Know Your Direction: Merit’s HeartSpan® Steerable Sheath Facilitates Catheter Navigation

Patients suffering from atrial fibrillation (AF) have a minimally-invasive curative treatment option thanks to advancements in cardiac ablation catheter technology. The use of one such advancement, the steerable sheath, has resulted in higher clinical success rates in comparison to using a traditional fixed sheath.1 But despite its clinical success, operating the steerable sheath has its challenges, such as knowing a sheath’s position when under fluoroscopy.

In an effort to anticipate clinicians’ needs, Merit Medical has designed a procedural solution called the HeartSpan® Steerable Sheath. It allows a clinician to move the distal tip from 0° and 180° to achieve the desired curve within the atrial chamber. Unlike any other steerable sheath on the market, the HeartSpan facilitates catheter navigation by offering a Neutral Position Indicator and a tactile click at the neutral position. For ease of use, its ergonomic handle displays two arrows that indicate the directional plane of the curve as the handle turns.

Reaching the desired catheter position by way of a steerable sheath has been shown to have several benefits. A randomized controlled study by Piorkowski et al. investigated the clinical outcomes of using a steerable sheath in comparison to a fixed sheath.1 The study prospectively included 130 patients with paroxysmal or persistent drug-refractory AF undergoing interventional cardiac ablation for the first time.

Results published in Circulation Arrhythmia and Electrophysiology showed that single procedure success was significantly higher in patients ablated with a steerable sheath (78% vs. 55% after 3 months; 76% vs. 53% after 6 months).1 Additionally, fluoroscopy time was lower in the steerable sheath group (33+/-14min vs. 45+/-17min). The authors concluded that using a steerable sheath improved catheter stability and catheter-to-tissue contact when compared to the traditional fixed sheath.

In addition to the Neutral Position Indicator, the HeartSpan has other state-of-the-art features that support procedural success. For navigating anatomical variations, the HeartSpan is available in three curl sizes. Its braided construction offers kink resistance and curve durability. A lower crossing profile enables seamless dilator to sheath transition for smooth advancement across the atrial septum. Radiopaque marker bands enhance visibility, and an atraumatic tip reduces the risk of atrial wall perforation. The HeartSpan’s shaft body is smooth and lubricious for easy vessel insertion.

Contact your Merit Representative for a clinical evaluation. Because when it comes to cardiac ablation catheters, you should always know your direction.

REFERENCES

  1. Piorkowski, C., Eitel, C., Rolf, S. et al. (2011). Steerable versus non-steerable sheath technology in atrial fibrillation ablation: a prospective randomized study. Circ Arrhythm Electrophysiol, Apr; 4(2): 157-65.

Merit Medical is pleased to sponsor an accredited webinar for Critical Care Nurses

Hemodynamic Monitoring is Monitoring Life

Watch the webinar

Earn: 1.00 CERP credit*

Course objective: Hemodynamic monitoring can be challenging, even for experienced nurses. This course establishes foundational knowledge related to the anatomy, physiology, and clinical care of patients on hemodynamic monitoring.

Speaker: Terry M. Foster, RN, MSN, FAEN, CCRN, CPEN, TCRN, CEN, Nurse Humorist

Terry M. Foster holds a Master’s Degree in Critical-Care and Trauma Nursing from the University of Cincinnati College of Nursing and Health, having previously earned his LPN and RN. His primary areas of nursing experience have always been in the Emergency Department and Critical-Care Units, holding several national certificates. Terry has lectured on a wide variety of clinical topics at nursing seminars and conferences throughout the USA, having given a total of over 5,000 formal presentations. He has authored more than 40 professional publications and is currently the Critical-Care Clinical Nurse Specialist in the six Emergency Departments at St. Elizabeth Healthcare in Edgewood, Kentucky. Read more about Terry Foster.

*This Program Has Been Approved by the American Association of Critical-Care Nurses (AACN) for 1.00 Synergy CERP Category A, File Number 21722.

The New Go-To: PreludeEASE™ Resists Compression Better Than the Leading Competitor

At Merit Medical, we’re dedicated to using the most advanced materials, designs, and manufacturing techniques with the goal of delivering solutions you can always depend on. Our PreludeEASE™ Hydrophilic Sheath Introducer is a perfect example of this commitment. Designed for strength, data shows the PreludeEASE resists compression better than the leading competitor—making it the New Go-To sheath.1

Compression resistance is an essential factor when considering a new sheath. Case studies have shown that if an arterial spasm occurs during a procedure, it can lead to the sheath compressing into the catheter, entrapping it within the vessel, and making removal of the catheter from the sheath difficult.2

Some thin-walled sheaths can be prone to compression and kinking that could result in difficult catheter manipulation. In the event of radial spasm, the catheter and sheath may need to be removed. Using a product with robust sheath tubing, like the PreludeEASE, may help clinicians avoid this problem. When tested against the leading competitor, the PreludeEASE displayed excellent compression-resistance performance.1

Other PreludeEASE advanced features include a large inner diameter for easier transitions and increased device compatibility and hydrophilic coating to facilitate insertion and removal as well as patient comfort.3 Moving smoothly from wire to dilator and dilator to sheath, the PreludeEASE streamlined design requires up to 30% less insertion force in comparison to the leading competitor.1

To accommodate varying patient anatomy, the PreludeEASE is available in multiple size configurations that range from 4F-7F diameters and can be customized in kits and packs to include other tools you need to achieve radial success.

Explore the New Go-To PreludeEASE and all it has to offer by visiting the PreludeEASE product page or talk to a knowledgeable Merit representative today.

REFERENCES

  1. In-House Data
  2. Popma, J. (2013). Radial Artery Complication: Case Presentation. SCAI 2013. [PowerPoint slides].
  3. Kiemeneij, F., Fraser, D., Slagboom, T., et al. (2003). Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths. Catheter Cardiovasc Interv, Jun; 59(2): 161-164.

I Am Merit: Fred Lampropoulos, Founder, Chairman and Chief Executive Officer



Thirty years ago, Merit Medical got its start by doing one simple thing: paying close attention to the clinical needs of physicians. At a time when glass syringes were the industry standard, Merit wanted to create something better. From this vision, the polycarbonate Coronary Control Syringe was born. It was the first of its kind and it was Merit’s first manufactured medical device on the market.

We sat down with Fred Lampropoulos, Chairman, CEO, and Founder of Merit Medical, to hear the full story of how this single innovation led to the rise of an international corporation that now employs almost 5,000 individuals and generates $750 million in global revenues.

“At the time, I had left as Chairman and CEO of Utah Medical, voluntarily. I really wanted to look at my life. I had thought about going to medical school,” Lampropoulos says. “After that, I decided I was going to start up a new company.”

In order to understand the clinical needs of the cardiology world, Fred did what any eager anthropologist would do and went native. He began spending much of his time with thoracic surgeons and cardiologists, scrubbing in on cases and observing everything possible. He describes this point in his life as a time he learned most simply by watching. Doing so allowed him to anticipate the needs of physicians and flex his creative muscles.

In one memorable instance, he describes a time when he noticed clinicians taking a spike, taping it onto a bottle of contrast media with the spike not fully inserted. “I could never figure out why they were doing that,” Lampropoulos recalls.  “I asked somebody and he said, ‘The stuff in this bottle is really expensive. We want to be able to have the spike where it’s at the lowest point possible. [The spike] either falls out, or someone will just barely tap it, and it’ll fall out. And you’ve got contrast [all over], which is very messy. So, we tape it.’”

This led to Fred’s first prototype.

“I came up with an idea that we’d develop a spike that had a little [part] you could push and the teeth would come over the head of the bottle and it would hold in there. It wouldn’t fall out,” Lampropoulos explains. “It was just observing and listening.”

As time went on, the art of observing and listening—that was once the foundation of a burgeoning business plan—turned into millions of dollars in sales and what sets Merit apart in the medical device industry today.

Referring to another unforgettable case, Fred describes a time when he observed a physician using a syringe filled with contrast and blood. “He was expelling it into a metal basin and [its contents] came up over the top and rolled down on the drape. It went all over the place,” Lampropoulos describes. “I went to the plant in the morning, got a couple of engineers together and said, “This is what I observed. This is what I heard. This is what I want to do.”

In a matter of hours, Fred’s team came back with a prototype, now sold as the Merit BackStop® Disposal Systems. “It was literally from just being there,” Lampropoulos says. “I think we have sold, over the years, 100 million dollars worth of those BackStops. But more important than just selling something is the fact that we have a containment device that helps to minimize bloodborne and airborne pathogens. That was the key. You can watch and listen, but it has to meet a customer need at the same time.”

As a US military officer and combat officer, Fred learned the importance of observing and listening, while simultaneously making decisions quickly. “You take a look at the business, how you strengthen it, and how you gain an advantage over your competitors,” Lampropoulos explains. “There are a lot of pieces that go into that.”

One significant piece that Fred attributes much of his success to is that of teamwork. An avid baseball fan, he compares the well-oiled machine that is Merit Medical to a “team that can play all the positions and can deliver runs and hits.” Full of “very competent, hardworking people who share a vision,” Merit Medical has been able to expand internationally.

With facilities in the US, The Netherlands, France, Ireland, China, Mexico, Brazil, Canada, Singapore, and Australia, Fred says Merit encompasses a core philosophy no matter where they are. “We’ve been able to build a company that really has encompassed a strategy. Whether you’re in Singapore, Galway, Tijuana, or Toronto, there’s a core of beliefs, standards, and efforts on how we all fit into this puzzle that ends up very candidly looking like a masterpiece.”

One only has to read Merit’s vision to see that it’s a customer-focused company in healthcare.  Determined each day to make a difference by “delivering products that improve the lives of people, families, and communities throughout the world,” Merit prides itself on driving the cost of medicine down. “I remember our inflation devices when we first started were selling for $85,” Lampropoulos continues. “Today, they sell for $30. We’ve made tools that make it easier for a physician to treat a patient. That’s a big deal.”

By providing tools that simplify and improve patient care, Merit has been able to make several primary therapies more accessible. Peritoneal dialysis, catheter ablation, uterine fibroid embolization (UFE), and the recent FDA-approved prostatic artery embolization (PAE) are only a handful of therapies Merit supplies with state-of-the-art tools and devices. “There are a lot of things we’re doing for patients, and in some cases, they wouldn’t have an alternative,” Lampropoulos notes. “We treat and save 15,000 lives a day. That number keeps going up.”

Looking into the future, Fred believes that in order to continue this crucial work, Merit must remain a steadfast leader in emerging therapies and technologies. Uninterested in short-term business deals, Fred says Merit will maintain its vision and invest long-term. “It’s a huge advantage over others who are being consolidated or are flipping a company or just trying to be a serial entrepreneur. It’s just never what I wanted to do,” Lampropoulos clarifies. “I wanted to build something of lasting value and I think we’ve done that.”

Long-term vision is what Fred says has done more than just make money. Because of the family values Fred has infused in his company, Merit has created countless jobs, fed and educated families, and helped send their children to college. “In some cases, we’re hiring their kids now as our engineers,” Lampropoulos adds. “That is very gratifying.”

From a community standpoint, Merit has supported the arts and sciences, as well as worked with homeless and youth centers—places where Fred believes Merit has a corporate responsibility. “It’s not some newfound belief. It’s something that we started out from the very beginning. I think we have been and have tried to be, within our means, a responsible corporate leader.”

When asked if he’s proud of all he has accomplished in the last 30 years, Fred remains humble. “I don’t think much about what I’ve done because I don’t have much time to do that,” he responds. “I don’t want to look at the back window, I want to look out the front window. Did we think we would be here today? The answer is we hoped we would be.”

Happy 25th Anniversary of Transradial Access!

Today, August 24th, marks the date 25 years ago when Dr. Ferdinand Kiemeneij performed the first radial access angioplasty in the Netherlands. Merit Medical is so pleased to celebrate this landmark anniversary with the physicians around the world who practice this patient-centric technique and with patients who have had a radial intervention.

Congratulations to Dr. Kiemeneij and fellow ThinkRadial Course Directors Dr. Sandeep Nathan (IC- University of Chicago, Chicago, IL) and Dr. Darren Klass (IR – Vancouver General and UBC Hospitals, Vancouver, CAN) for your efforts to move this technique forward.

THINKRADIAL COURSE INFORMATION

Navigating through vascular anatomy with the InQwire® Amplatz Guide Wire

Navigating through difficult vascular anatomy can be challenging, and finding just the right guide wire to do so can be even more difficult.  Ultimately, clinicians need a wire that is reliable and that can get them to their destination within the vasculature, even if the path is a tortuous one. Look no further, because the new InQwire Amplatz guide wire was designed to do just that.

A firm inner core, a smooth transition and a lubricous coating are key elements for reliable guide wire navigation. With those elements in mind, the InQwire Amplatz wire was carefully designed to be a tool for precision, agility, and strength. The wire’s firm construction provides an increased level of stiffness that delivers extra support and stability within the vasculature, specifically for enhanced navigation.

A flat outer wire coil allows a larger inner core to provide added stiffness which facilitates catheter placement and advancement of other devices, such as dilatation catheters and stent catheters during contralateral access. A smooth tapered transition from the shaft to the flexible tip, allows atraumatic negotiation of the most difficult vascular anatomy.

A proprietary outer coating was added to the entire surface of the wire to facilitate smooth navigation with less resistance against vessel walls. In testing the wire’s performance against the leading competitor, the InQwire Amplatz proved to be superior and was documented as having a 20% higher lubricity rating*. The Merit InQwire Amplatz wire requires considerably lower force per grams, therefore allowing catheters to move more easily over the wire.

The InQwire Amplatz is compatible with 0.035” & 0.038” devices and for added convenience the Amplatz wires are available in multiple tip configurations to include straight-tip wires in a variety of flexible profiles including 1.0cm, 3.5cm, 4.0cm, 6cm, and 7cm. A J3mm tip configuration is also available.

For additional information visit Merit.com/Amplatz or contact your local Merit representative.

*Data on file

I Am Merit: April Sanchez, Supervisor of Strategic Accounts Contract Management

An important part of Merit Medical’s business involves working with Group Purchasing Organizations and Integrated Delivery Networks around the United States. April Sanchez, Merit’s Supervisor of Strategic Accounts Contract Management, speaks about her team’s role to provide important financial impact and analysis of Merit’s contracts with these GPOs and IDNs. The efforts of Strategic Accounts allows Merit to form lasting relationships with customers and provides them with access to products to improve and save the lives of their patients.

Why Use a Closed-Flush Blood Sampling System?

A critically ill patient may enter the ICU because of organ failure, extreme dehydration, Sepsis, or some other complicated issue. In all of these conditions, a quick response is best for a positive patient outcome. Invasive hemodynamic monitoring allows a healthcare provider to access real-time information about the patient’s cardiac health. Additionally, blood samples are a routine and vital process to assess the patient’s lung function and perfusion. Multiple blood samples per day is not uncommon in the ICU; however, providers may be unaware of the inherent risks of drawing blood.

Each time a blood sample is drawn, the potential for contamination and blood discard is present. The CDC has made recommendations for improving blood sampling, including the use of a pressure monitoring system with a closed-flush (continuous-flush) sampling system. This type of system can help prevent air-borne contaminants from entering the blood stream. In a study comparing bacterial contamination in arterial lines, the results stated: “There was less microbial contamination of intraluminal fluid when BCS [a blood conservation system] was used for arterial catheterization.”1 Another study, measuring hemoglobin and hematocrit counts of critically ill patients having multiple blood samples drawn, indicated that the use of a closed blood sampling system was able to minimize blood count value changes.2

Merit Medical is proud to offer a portfolio of critical care products including invasive hemodynamic monitoring sets. The MeritransDTXPlus® with Safedraw® closed arterial sampling helps minimize the risk of infection and unnecessary exposure with a simple, closed, in-line arterial sampling system. Unlike other pressure monitoring systems, the EasyVent™ closed zero port allows clinicians to maintain a closed system when priming or zeroing the transducer (not opening the system to the ambient environment reduces patient risk and enhances overall safety).

A new critical care catalog and a brochure are available showing Merit’s critical care portfolio.

  1. Oto J, Nakataki E, Hata M, Tsunano Y, Okuda N, Imanaka H, Nishimura M. (2012 Aug). Comparison of bacterial contamination of blood conservation system and stopcock system arterial sampling lines used in critically ill patients. Am J Infect Control, 40(6):530-4. doi: 10.1016/j.ajic.2011.08.006. Epub2011 Nov 3.
  2. Rezende E, Ferez MA, Silva Junior JM, Oliveira AM, Viana RA, Mendes CL, Toledo Dde O, Ribeiro Neto MC, Setoyama TA. (2010 Mar). Closed system for blood sampling and transfusion in critically ill patients. Rev Bras Ter Intensiva,  22(1):5-10.

SwiftNINJA® Successfully Embolizes Post-EVAR Type II Endoleaks Using Transarterial Iliolumbar Approach

Endovascular aneurysm repair (EVAR) has been linked to the formation of type II endoleaks. The transarterial iliolumbar approach to repair this complication is occasionally difficult and associated with a lower technical success rate due to the anatomical features of the area.

However, earlier this year Dr. Yunosuke Nishihara of Saga-Ken Medical Centre Koseikan in Saga, Japan, discussed two cases in which the SwiftNINJA® Steerable Microcatheter successfully embolized type II endoleaks using the iliolumbar artery approach after attempts employing other microcatheters and conventional catheterization techniques had failed.

Case 1: A 68-year-old female patient

  • EVAR was performed in January 2014, immediately followed by a persistent type II endoleak and increased diameter of the aneurysm.
  • Transfemoral transarterial embolization was attempted in March 2015 but failed because selection of the iliolumbar artery and beyond was not possible.
  • At follow up, the aneurysm size was 15 mm greater than the previous year. Transarterial iliolumbar embolization using the SwiftNINJA was performed in March 2016.
  • The SwiftNINJA was articulated to cannulate a strong angle bifurcation. Locking and unlocking the tip of the SwiftNINJA at an angle along the bifurcation allowed for easy vessel selection and advancing of the guidewire.
  • After exchanging the catheter, the tip of the selective microcatheter was guided into the aneurysm sac; the endoleak cavity and feeding artery were embolized.
  • After embolization, no blood flow into the endoleak cavity was observed. 

Case 2: A 78-year-old male patient

  • EVAR was performed in January 2014, immediately followed by a persistent type II endoleak.
  • The aneurysm size was 8 mm greater than the previous year and the patient was admitted in March 2016 to undergo embolization via the transarterial iliolumbar approach using the SwiftNINJA.
  • The SwiftNINJA was the primary microcatheter used to cannulate the aneurysm and was guided to the bifurcation without a guidewire.
  • A guidewire was then successfully placed into the aneurysms feeding vessel and the SwiftNINJA was induced successfully.
  • After exchanging the catheter, the tip of the selective microcatheter was guided into the endoleak cavity.
  • The endoleak cavity was embolized and coil embolization was performed successfully on suspected feeding and/or outflow vessels.

Despite the complexities surrounding the transarterial iliolumbar approach, the author noted that the SwiftNINJA improved the selectivity of target vessels and provided enough support for guidewire introduction into acute bifurcating vessels to not allow catheter kickback. These device advantages can lead to other patient and clinician benefits.


“When this useful device [is] appropriately used, we can expect the reduction of operation time, X-ray exposure and the amount of contrast medium used.”

SwiftNINJA® Steerable Microcatheter

Merit Medical’s SwiftNINJA® Steerable Microcatheter is the single most advanced and only 180-degree articulating microcatheter on the market. Able to navigate difficult vasculature, the SwiftNINJA offers unparalleled performance by utilizing three main advantages: speed, control, and delivery.

To learn more about the SwiftNINJA, please click here:

https://www.merit.com/interventional-oncology-spine/accessories/microcatheters/swiftninja-steerable-microcatheter/

REFERENCE

Nishihara, Y. (2017). Embolization of post-EVAR type II endoleaks using SwiftNINJA® [White paper]. Sumitomo Bakelite Co., LTD., Tokyo, Japan: Medical Products Business Division.

Dr. Yunosuke Nishihara received payment from Sumitomo Bakelite Co., Ltd. for the performance of this study.

NextGenRadial programs and products from Merit Medical

In a press release issued last week, Merit Medical announced its Advanced ThinkRadial Program for Interventional Cardiologists (IC’s), with a curriculum focused on complex interventions accessed via the radial artery. The course will be co-proctored by Interventional Cardiologist Dr. Sandeep Nathan (University of Chicago) and special guest of honor, Dr. Ferdinand Kiemeneij (Tergooi Hospital in Blaricum, The Netherlands), the Father of Transradial Intervention. This course is unique because it focuses on moving IC’s with radial experience to the next level of radial interventions. It will include advanced case presentations, hands-on experiences, and a special presentation by Dr. Kiemeneij about left distal transradial access, the Next Generation of the Radial technique.

Merit is very fortunate to have Dr. Nathan and Dr. Kiemeneij co-proctor the upcoming Advanced Course for Interventional Cardiologists, which will be held October 13-14, 2017 at the Merit Medical Education Center in Salt Lake City, Utah. Dr. Kiemeneij will also co-proctor a total of five courses in 2018 at both the Merit Education Centers in Salt Lake City, Utah and in Maastricht, Netherlands.

Fully committed to the radial approach, Merit offers a full portfolio of radial products, from set-up and access to hemostasis, as well as the ThinkRadial Education Program. Dr. Kiemeneij recently tweeted about using the PreludeEASE for left distal transradial access, a next gen radial entry site in the hand. Read more about his statement in the press release or on twitter.

For more information about Merit Medical and the Next Generation of radial products and programs, visit Merit.com/NextGenRadial.

HeRO Graft Dramatically Reduces Infection Among Catheter-Dependent Patients

Approximately 80% of patients starting hemodialysis use tunneled dialysis catheters, while 25% of all prevalent patients have one placed as a bridge to permanent vascular access, or because all other options for permanent access have failed.1 And yet, catheter dependency still poses the risk of infection. Current research is now pointing to an alternative to catheter use among access-challenged hemodialysis patients: permanent subcutaneous arteriovenous graft devices. Data has shown that the HeRO™ (Hemodialysis Reliable Outflow) Graft is the only clinically proven permanent subcutaneous arteriovenous graft to reduce the risk of vascular access-related infections by 69% when compared to tunneled catheters.2

Unlike other graft devices, HeRO Graft technology improves long-term hemodialysis by way of a Venous Outflow component that’s placed in the right atrium, which then attaches to an adjacent ePTFE hemodialysis graft via a proprietary titanium connector. This mechanism allows for blood to return from an artery back to the heart, bypassing central venous occlusions—a common complication seen among catheter-dependent long-term dialysis patients.

When the HeRO Graft was compared to tunneled dialysis catheter use, access-related bacteremia rates were significantly lower (0.7 events/ 1000 days). Reported infection only occurred during the bridging period when a catheter was implanted prior to a HeRO Graft being used.2

In an effort to circumvent the 2-4 week bridging period and avoid this risk of infection, Merit launched the Super HeRO™ Adapter in 2016. Made with the same HeRO Graft technology, the Super HeRO Adapter has the advantage of wide range graft compatibility. In this instance, by connecting the Super HeRO Adapter to a compatible early cannulation graft, a patient can be implanted today and dialyzed the next, virtually eliminating the risk of access-related infection due to a bridging catheter.

The Super HeRO Adapter is also designed for long-term, access-challenged hemodialysis patients who still have a working Venous Outflow component but need a new graft. Available through the HeRO Ally™ Revision Kit, this option provides clinicians with the tools they need to replace an old graft with a compatible graft of their choice.

In addition, eliminating risks associated with vascular access infection can lead to healthcare cost-savings. A US healthcare model for provision of dialysis access predicted that in comparison to catheters, implementing HeRO technology could result in an average of 23% annual savings—with infection observed as one of the primary determinants of cost.3

In order to meet the diverse needs of patients, dialysis technology is continuously evolving. By taking advantage of innovative tools, clinicians can improve the dialysis experience for catheter-dependent patients, offering them better treatment and a new outlook on life.

As an option to help improve patient care and save on healthcare related costs, Merit Medical offers an in-depth, hands-on training course – THINK ACCESS – that covers techniques for HeRO graft implantation. To be considered for an upcoming THINK ACCESS course, visit the link below to sign-up.

https://www.merit.com/education/course_dates/#Hero

  1. Clin J Am Soc Nephrol. 2011;6: 2247-52.
  2. J Vasc Surg. 2009;50: 600-607.
  3. J Surg Res. 2012;177: 165-171.

SwiftNINJA® Steerable Microcatheter Should be Your “Work Horse” Device, New Case Report Suggests

In the May 2017 issue of Radiology Case Reports, Hinrichs, Marquardt, Wacker, and Meyer reviewed two potential solutions to successfully coil embolize patients with hepatointestinal collateral (HIC) vessels precluding radioembolization. The second solution presented is to use the SwiftNINJA® Steerable Microcatheter as a “work horse” device in appropriate situations, as opposed to a “problem-solving” device, as it is sometimes considered.

  • In the second case, a 59-year-old male is presented who suffers from bilobar multifocal hepatocellular carcinoma (HCC).
  • After coil embolization was performed on the right gastric artery, cystic artery and gastroduodenal artery, an angiogram revealed a small, reverse-curved HIC.
  • Radioembolization was determined to be contraindicated in the patient after catheterization of the HIC using regular microcatheters was unsuccessful.
  • After introduction to the SwiftNINJA Steerable Microcatheter®, the patient was brought back four weeks later.
  • The patient’s HIC was then accessed by positioning the SwiftNINJA® catheter tip near the origin and repeating inflection until the catheter tip hooked into the feeder. Once the SwiftNINJA® was locked in an inflected configuration, a 2-mm pushable straight coil was advanced.
  • Radioembolization was performed successfully 20 days later.

The authors note that given the numerous regular microcatheters that were used initially in the case without success, in appropriate cases it is more cost-effective to use the SwiftNINJA® first as a “work horse” device, rather than a “problem-solving” device.

“The [SwiftNINJA®] represents a new device class and has the potential to expand the armamentarium of interventional radiology in oncology patients and might be of high value in this and numerous other endovascular interventions.”

http://www.sciencedirect.com/science/article/pii/S1930043317301206

SwiftNINJA® Steerable Microcatheter

Merit Medical’s SwiftNINJA® Steerable Microcatheter is the single most advanced and only 180-degree articulating microcatheter on the market. Able to navigate difficult vasculature, the SwiftNINJA® offers unparalleled performance by utilizing three main advantages: speed, control, delivery.

To learn more about the SwiftNINJA®, please click here:

https://www.merit.com/interventional-oncology-spine/accessories/microcatheters/swiftninja-steerable-microcatheter/

REFERENCE

Hinrichs, J. B, Marquardt, S., Wacker, F. K, & Meyer, B. C. (2017). Coil embolization of reversed-curve hepatointestinal collaterals in radioembolization: potential solutions for a challenging task. Radiol Case Rep, http://dx.doi.org/10.1016/j.radcr.2017.04.006

New Interventional CRT Center of Excellence at MedStar

Merit Medical is pleased to announce a new Interventional CRT Center of Excellence at the MedStar Washington Hospital Center, Heart & Vascular Institute, in Washington, DC. Dr. Seth Worley, an internationally recognized expert in cardiac resynchronization therapy, began developing Interventional CRT techniques 18 years ago. He recently moved his practice to MedStar Washington Hospital to launch the hospital’s Interventional CRT program. Training opportunities will be available at the MedStar Center of Excellence beginning this September.

Interventional CRT is a progressive way of implanting LV leads using interventional cardiology tools and techniques. It uses an injection system and specially designed tools to facilitate CS Cannulation and LV lead placement. Utilizing these tools allows implanters to simplify their straightforward cases or provide options for challenging anatomies.

During the MedStar Center of Excellence courses, implanting physicians and fellows learn Interventional CRT techniques including CS Cannulation, Snaring, telescoping, venoplasty, visualization, and wire techniques.  Didactic presentations, hands-on workshops, and live case observations make these programs valuable for electrophysiologists looking for options for LV lead implantation.

In addition to in-person training, the Interventional CRT program offers step-by-step guides for cannulating the CS as well as an instructional video to assist implanting physicians. The Step-by-Step Guide is available as a booklet or poster that can be downloaded. New guides for Snaring and other techniques will be available soon.

MedStar Heart and Vascular Institute has been the premier destination for advanced, complex cardiovascular care in the Washington DC Metropolitan region for more than 55 years, and is consistently ranked as one of the top cardiovascular programs in the nation by U.S.News & World Report (www.medstarwashington.org).

For more information about Interventional CRT training opportunities and availability in the MedStar Center of Excellence programs, contact Marni Adams, Program Director ([email protected], 503-867-4150) or visit InterventionalCRT.com.

StabiliT Bone Cement Offers Physicians Key Clinical Advantages – An Interview with Dr. Jayson S. Brower

The success of percutaneous vertebral augmentation (PVA) relies on the quality of its bone cement. To relieve the pain that accompanies pathologic vertebral compression fractures, cement must be injected into affected vertebra with precision and control. To accomplish this, Merit Medical launched its proprietary StabiliT Bone Cement that offers physicians two significant advantages over other cements on the market.

“There are multiple factors that contribute to StabiliT Bone Cement’s advantages from my perspective as a treating clinician: extended working time and increased viscosity,” says Jayson S. Brower, MD, Radiologist at Inland Imaging Associates and Providence Sacred Heart Hospital in Spokane, WA. “With StabiliT cement, you have more control. Increased working time allows you to take your time. Because of its viscosity, you have more confidence in where you’re putting the cement into the bone.”

Using conventional high-viscosity bone cement often translates into shorter working times. Merit’s StabiliT Bone Cement maintains its high-viscosity with a working time of 35-minutes. When used with the original StabiliT Vertebral Augmentation System, higher levels of radiofrequency (RF) energy are initially applied to the cement to increase its viscosity but then taper off over the length of the procedure. This allows control of the polymerization, making the delivery of high-viscosity cement over an extended working time possible.

Maintaining this viscosity has its clinical benefits especially when managing common complications like cement extravasation. According to Dr. Brower, whether a physician is treating pathologic fractures or osteoporotic fractures, cement potentially leaking outside of the vertebral body is a widespread concern but one that a highly viscous cement can ameliorate.

“Because of StabiliT’s increased viscosity, you have confidence that this cement is far less likely to leak,” Dr. Brower explains. “If you have large fracture planes or are treating pathologic fractures due to vertebral metastatic tumors, you’re potentially concerned about cement leakage. For example, when there’s disruption of the posterior aspect of the vertebral body that reaches into the spinal canal, using StabiliT Bone Cement offers a huge advantage.”

What’s more, using bone cement that retains a high viscosity over the length of a procedure affords time to address or even revisit areas of concern. “StabiliT’s prolonged working time allows you to install a bit of cement, let it set up, go back, and place additional cement,” Dr. Brower continues. “Or if you don’t get the optimal spread, you can go back, form additional channels, and place additional cement in that same level.”

To offer these same benefits to physicians with varying clinical needs and patient requirements, Merit introduced the StabiliT MX Vertebral Augmentation System—a simplified system that only requires the use of a precision syringe to deliver high-viscosity cement.

“A great opportunity for the MX system would be in an outpatient practice, treating in an ambulatory setting,” Dr. Brower notes. “The lower cost, combined with increased control of the StabiliT Cement, would be a huge advantage. It could give a clinician the chance to use a potentially more expensive system in a cost-effective way and leverage the safety and efficacy of the MX cement in that outpatient setting.”

Limited working time and unreliable cement viscosity have often left physicians rushing to complete a procedure. StabiliT Bone Cement’s versatility and many clinical advantages, mainly its extended working time and dependable high-viscosity, have made it the bone cement of choice.

“I’ve used just about everything on the market and, through trial and error, I’ve realized there’s nothing quite like it. I use StabiliT Bone Cement exclusively,” Dr. Brower adds. “I think the clinical advantages warrant its use.”

Alicia Armeli and Dr. Brower are paid consultants of Merit Medical. For more information please refer to Instructions for Use. Consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

Targeted Vertebral Procedures for Vertebral Compression Fracture (VCF) and Metastatic Spinal Tumors

Learn the demographics, diagnoses and most current clinical evidence regarding minimally invasive procedures for the treatment of pathologic vertebral fractures and spine tumor ablation.

Announcing September Think Access™ Education Course

Have you signed up for the September Think Access™ training course yet? September’s training is the first time that superpowers have been combined, adding comprehensive training for both the HeRO®/Super HeRO® Graft and for Peritoneal Dialysis (PD) systems. We are happy to announce that training for this exclusive course will be held at the VISTA lab in Baltimore, Maryland Friday, September 15th through Saturday the 16th.

HeRO Graft and PD training at VISTA means you’ll have the opportunity to learn cutting-edge skills and have access to the latest technologies that will help support the advancement of your interventional and surgical procedures. September’s Think Access course is like no other because you’ll be able to rehearse, perfect, and perform techniques using cadavers (HeRO portion only) and simulators in a state-of-the-art facility. Broken up into two groups for more individualized instruction, training such as placing new implants and catheters as well as complications/tips and tricks will be covered. For HeRO, you’ll revisit existing implants, placement of the venous outflow component from different access sites, identifying the anastomosis and tunneling will be addressed. These topics will be put into practice again in the SIM Lab using VISTA’s advanced training models.

Clinical discussions will also be taking place throughout the course that focus on PD and HeRO Graft tips, troubleshooting, and clinical guidelines. You’ll be invited to dive into several case study discussions with other physicians, enabling you to familiarize yourself with HeRO and PD clinical scenarios that will help prepare you for challenging cases.

You’ll be taught by two of the foremost thought leaders, John H. Crabtree, MD Chair of PD University for Surgeons-North America and Jesse Garcia, MD, Vascular Surgeon at MedStar Heart & Vasculature Institute at MedStar Washington Hospital Center.

Dr. Crabtree has pioneered modifications and enhancements to the laparoscopic placement for peritoneal dialysis patients and has authored numerous articles covering dialysis catheters, implantation techniques, and resolution of dialysis access complications. He currently serves as Visiting Clinical Faculty at Harbor-UCLA Medical Center and as the Activity Director for ISPD-sponsored surgeon education programs for Europe.

Jesse Garcia, MD, is a board-certified general surgeon who specializes in vascular access surgery for patients diagnosed with kidney failure who need dialysis. His passion for practicing medicine began with his father, who led the cardiac surgery program at MedStar Washington Hospital Center into the 1980s.

Dr. Garcia is part of a team of vascular surgeons at MedStar Heart and Vascular
Institute (MHVI) that is performing the greatest volume of HeRO™ graft placements in the country. This unique new technology has made a dramatic impact on patients’ lives because it reduces significantly the risk and frequency of infection associated with the standard venous catheter use.

Sign up today to be part of September’s special Think Access training held at the VISTA Lab in Baltimore. We look forward to seeing you there!

PreludeEASE™ Hydrophilic Sheath Introducer: The New GO-TO

Merit Medical is committed to the radial approach, with a comprehensive portfolio of radial products supporting radial procedures from set-up and access through hemostasis, as well as the ThinkRadial training program for Interventional Cardiologists and Radiologists. And in this year, the 25th anniversary of radial access, we are happy to spotlight some of our key radial products, starting with the sheath used to gain access to the radial artery.

The has evolved to address the needs of radial interventionalists. The smooth transitions between wire to dilator, and dilator to sheath, have been fine tuned for patient comfort, resulting in up to 30% less insertion force, as compared to the leading competitor1. The hydrophilic coating further facilitates insertion and removal as well as patient comfort.2

Studies also show that the hydrophilic coating on sheath introducers can reduce the incidence of artery spasm and improve patient comfort during transradial diagnostic and interventional coronary procedures.3

The PreludeEASE™ maintains a robust design that resists kinking while still providing a large inner diameter for increased device compatibility. Combining a slim profile and a large inner diameter, the PreludeEASE provides optimal dimensions without compromising integrity or performance.

On May 31, 2017, Dr. Ferdinand Kiemeneij, “@ferdikiem”, tweeted about the PreludeEASE:

Available in 4F through 7F diameters and multiple lengths. Discover what the next generation of radial access products from Merit can do at merit.com/nextgenradial. #nextgenradial

  1. 6F data on file
  2. Kiemeneij F, Fraser D, Slagboom T, Laarman G, van der Wieken R. Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths.
    Catheter Cardiovasc Interv. 2003 Jun;59(2) 161-4.
  3. Rathore, S., Stables, R., Pauriah, M., Hakeem, A., Mills, J., & Palmer, N. et al. (2010). Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention. JACC: Cardiovascular Interventions, 3(5): 475-483. https://www.ncbi.nlm.nih.gov/pubmed/20488402

Announcing – ThinkPAE™ Education Course

Merit Medical is excited to announce the ThinkPAE™ – Interventional Techniques for Prostatic Artery Embolization education course, and the first course date on August 25-26, 2017 proctored by Dr. Shivank Bhatia.

Prostatic artery embolization (PAE) is a non-surgical treatment for lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH). BPH is the most common benign neoplasm in men, with more than half of men aged 60-69 years and as many as 90% aged 70-89 years having some symptoms.1

Clinically shown to reduce BPH symptoms and improve quality of life, PAE has become a viable alternative to surgical procedures, with minimal risk of urinary incontinence or sexual dysfunction such as impotence and retrograde ejaculation. PAE also offers a shorter recovery time compared to surgical options and can be performed via the femoral or radial artery. Merit Medical recently announced FDA 513(f)(2) (de novo) classification for prostatic artery embolization (PAE) indication for symptomatic BPH.

Merit Medical’s ThinkPAE™ education course will be taught by one of the world’s leading experts in PAE, Dr. Shivank Bhatia, and will include training to perform PAE via the radial artery, preferred by many patients for interventional procedures. The first course will be hosted at the Merit Medical Education Center in Salt Lake City, UT.

Dr. Shivank Bhatia is an Associate Professor of Interventional Radiology and Urology at University of Miami Miller School of Medicine. He has extensive experience with Prostatic Artery Embolization and has built a multidisciplinary program with the Department of Urology at University of Miami. Due to his significant collaboration with the Urology Department at University of Miami, he was awarded title of Associate Professor of Urology in 2015.

What are the learning objectives of the course?

  • Prostatic Arterial Anatomy – learn to identify and work around arterial anomalies
  • PAE Technical Aspects – learn the proper tools for technical success, imaging protocols and interpretation
  • Radial Access – learn the technique and benefits of radial access for PAE
  • Peer Collaboration – discuss a multidisciplinary approach to PAE
  • Complex Cases – learn how to navigate obstacles and complex cases

For more information about this course, download the course flyer.

Interested in attending? Please complete the Interest Form online at Merit.com/Education.

Due to the high demand and limited seating in this course, we will contact you within a few weeks about availability. Future dates will be announced soon.

  1. Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in America project: benign prostatic hyperplasia. J Urol 2005; 173: 1256–1261

StabiliT Bone Cement – Trusted Cement. Simplified Delivery.

Thirty years ago, the first-generation percutaneous vertebral augmentation (PVA) system was introduced for the management of painful pathologic vertebral compression fractures. Since then, PVA treatment has had dramatic improvements in both bone cement formulations and delivery systems.

For example, higher cement viscosity has been considered desirable in recent years, but as viscosity increases, working time decreases. Therefore, conventional high-viscosity cements, with relatively short working times, often result in cement clogging the delivery system prior to the physician completing a procedure.

To address such challenges head on, Merit Medical’s portfolio of StabiliT Bone Cement with expanded delivery options in the StabiliT Vertebral Augmentation Systems has two main advancements over the competition: 35-minutes extended working time with remotely controlled delivery and trusted high-viscosity bone cement.

Merit’s unique proprietary StabiliT Bone Cement formulation offers physicians time flexibility to do a procedure in a controlled fashion, regardless of its complexity and number of levels requiring treatment. Physicians can also routinely initiate procedures with a unipedicular approach and still have adequate working time to convert to a bipedicular procedure, if required, avoiding the need to rush or mix additional cement.

Complex procedures that necessitate extended working time can also depend on StabiliT Bone Cement maintaining its high-viscosity. Bone cement viscosity has been shown to correlate to procedural success. How bone cement interacts with the fractured vertebral body determines how the cement stabilizes a fracture and/or extravasates (leaks).1 In an ex-vivo assessment of vertebral augmentation procedures, Lador et al. noted that several factors, specifically cement viscosity and rate of delivery, could influence cement flow within and leakage out of the vertebral body.1,2 Georgy reported approximately 50% less cement leakage using a controlled delivery of ultra-high viscosity cement after cavity creation with an osteotome compared to a lower viscosity cement in balloon kyphoplasty cases.3

In the original StabiliT Vertebral Augmentation System, proprietary ultra-high viscosity bone cement is heated with radiofrequency (RF) as it passes through a warming cartridge and its polymerization is accelerated just prior to being delivered into the vertebra. The controller’s software algorithm applies more RF energy initially to rapidly increase the cement viscosity and then less as time goes on, enabling the delivery of the same ultra-high viscosity over an extended working time. Delivery of this ultra-high viscosity cement is remotely controlled by the physician at an optimized delivery rate.

In response to some physicians desiring this same control but in a simplified design, Merit launched the StabiliT MX Vertebral Augmentation System. The StabiliT MX uses high-viscosity bone cement that has the same clinical benefits and same 35-minute extended working time, but it doesn’t require a controller or RF energy. The StabiliT MX provides high-viscosity cement that’s hand delivered using an ergonomic precision syringe.

The StabiliT MX delivery syringe contains a quick release clutch mechanism that allows for immediate cement flow stoppage. The use of a 3-foot hydraulic line increases the distance from which cement is conventionally hand delivered, helping to minimize a physician’s radiation exposure.4 Other features include a unique vacuum-based mixing system and articulating instrumentation for site and size specific cavity creation.

PVA treatment has been shown to significantly relieve pain of vertebral compression fractures.5 Merit is committed to providing technology that gives physicians maximum control as well as flexibility in cement and delivery options in order to optimize patient care. By using Merit’s trusted cement and simplified delivery systems, why not bring these benefits to your practice?

Alicia Armeli is a paid consultant of Merit Medical. For more information please refer to Instructions for Use. Consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

 

REFERENCES

  1. Lador, R., Dreiangel, N., Ben-Galim, P., et al. (2010). A pictorial classification atlas of cement extravasation with vertebral augmentation. Spine J, Dec; 10(12): 1118-1127.
  2. Loeffel, M., Ferguson, S. J., Nolte, L. P., et al. (2008). Vertebroplasty: experimental characterization of polymethylmethacrylate bone cement spreading as a function of viscosity, bone porosity, and flow rate. Spine, May; 33(12):1352–1359.
  3. Georgy, B. (2013). Comparison between radiofrequency targeted vertebral augmentation and balloon kyphoplasty in the treatment of vertebral compression fractures: addressing factors that affect cement extravasation and Pain Physician, Sept-Oct; 16(5): E513-518.
  4. Radiology Masterclass. (n.d.). Basics of X-Ray Physics. Retreived from http://www.radiologymasterclass.co.uk/tutorials/physics/x-ray_physics_safety
  5. Mpotsaris, A., Abdolvahabi, R., Hoffleith, B., et al. (2011). Percutaneous vertebroplasty in vertebral compression fractures of benign or malignant origin: a prospective study of 1188 patients with follow-up of 12 months. Dtsch Arztebl Int, May; 108(19): 331-338.

Dr. Ferdinand Kiemeneij Returns to Merit Medical to co-proctor the October ThinkRadial Course

Merit Medical will be hosting the next ThinkRadial Education Course on October 13-14 for Interventional Cardiologists and Radiologists. Physicians are already looking forward to this course and the opportunity to learn from the “Father of Transradial Intervention,” Dr. Ferdinand Kiemeneij.  Merit is honored to once again have Dr. Kiemeneij proctor this course, to share his extensive knowledge and experience, as he did in the April ThinkRadial Course. This course will be held at the Merit Medical Global headquarters in Salt Lake City, UT on Friday, October 13 and Saturday, October 14, 2017.

Interventional Cardiologists who currently practice the transradial access technique, who want to advance their skills for more complex interventional procedures, will be proctored by Dr. Sandeep Nathan (University of Chicago) as well as Dr. Ferdinand Kiemeneij. Interventional Cardiologists attending the course will present their own complex cases for discussion and troubleshooting as well as observe complex taped cases. These physicians will learn how to navigate potential complications and increase their use of transradial for complex interventions.

Interventional Radiologists who are new to the radial approach as well as those who want to increase their knowledge and skill will be proctored by Dr. Darren Klass (Vancouver General and UBC Hospitals). Interventional Radiologists will be taught the data and economics supporting transradial access, learn about patient selection, room set-up, and equipment selection. They will learn and practice access and hemostasis techniques and discuss how to navigate potential complications. Both groups will have the opportunity to practice the radial technique on cadavers.

Dr. Kiemeneij performed the first transradial coronary angioplasty in 1992, followed by transradial stenting in the same year and stenting on an outpatient basis in 1994.

Dr. Klass is an expert in transradial radioembolization and is developing a robust hardware platform for radial access to the liver. His practice is 90% radial for liver interventions and fibroid embolization.

Dr. Nathan describes his mindset as “radial first” and utilizes the transradial approach in more than 75% of his coronary cases. He believes that transradial “is a golden opportunity to improve patient comfort and safety, without compromising procedural efficacy.”

The October ThinkRadial Course is a full day and a half of didactic presentations, taped cases and hands-on training opportunities, complimented by a group dinner and presentation by the guest of honor, Dr. Ferdinand Kiemeneij.

To register for a course, visit our Education Page

For more information, please visit ThinkRadial.com

Accuracy matters. We help you get there.

Since Merit Medical’s founding, we’ve set out to build the world’s most customer-focused healthcare company by understanding customers’ needs and innovating a diverse range of products that improve the lives of people. Our Interventional Oncology & Spine (IOS) products illustrate just this, and we are excited to present several of them to you at the World Conference of Interventional Oncology (WCIO) 2017.

We continually hear from our physician customers that they need tools to help deliver therapies to difficult anatomy. So, our focus for this year’s WCIO is to highlight two devices that aim to provide these navigation solutions, with the ability to reach challenging anatomy with accuracy.

SwiftNINJA® Steerable Microcatheter – The SwiftNINJA® steerable microcatheter is the most advanced and only 180° articulating microcatheter on the market today. It allows for positioning and re-direction within the vessel without the need for a micro guide wire. The proprietary straight-tip catheter articulates up to 180° in opposing directions to rapidly select the most challenging and complex vasculature during embolization procedures.

“The frequent insertion and removal of guidewires during superselective catherization can be minimalized by using a microcatheter with an articulating tip. Using a SwiftNINJA® can potentially simplify and shorten the procedure.”
-Dr. Yasuaki Arai, Chief, Department of Diagnostic Radiology, National Cancer Center of Japan

STAR™ Tumor Ablation System – The STAR™ Tumor Ablation System is designed for the palliative treatment of painful metastatic spinal tumors. Included in this system is the SpineSTAR® Ablation Instrument, which allows for precise navigation through the pedicle and into the desired areas of the vertebra-containing tumor, allowing for fast, targeted tumor ablation.

“There are a number of features of the [SpineSTAR®] device that I really like. The articulating tip allows and facilitates reaching to areas in the vertebrae that are not possible with a straight fixed device.”
-Dr. Aaron Frodsham, Interventional Radiology, University of Utah Huntsman Cancer Center

Come to booth #510 to learn more about navigation with the SwiftNINJA® and SpineSTAR®.

WCIO will also be conducting several workshops where you can view these products.

Friday, June 9 | 9:15-10:45am | MSK & Spine Interventions
Saturday, June 10 | 9:15-10:45am | Ablative Therapies
Saturday, June 10 | 1:30-3:00pm | Hepatic Intra-Arterial Therapies

Click here to learn more about Merit’s WCIO attendance and workshops.

For a complete step-by-step guide to delivery, refer to Instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

Merit Medical loves Critical Care Nurses!

Merit Medical recently joined the Critical Care community and was pleased to attend the AACN’s National Teaching Institute and Critical Care Exposition (NTI) in Houston May 23-25, 2017. At our first-ever NTI expo booth, we met hundreds of critical care nurses over ice cream at the Merit Ice Cream Café, during in-booth educational sessions, and while discussing our critical care product portfolio.

Our booth featured the Merit Ice Cream Café, which provided a fun treat throughout each of the ExpoEd presentations. Adhering to our commitment to education, the Merit-sponsored presentations were well attended, providing CERP credits and valuable information. Nurses learned techniques for preventing CLABSIs as well as strategies for treating Sepsis successfully.

For those who wish to review the information presented on their own time, the presentations are available for download:

      • Preventing CLABSIs: Tales from the Front Line (Donna Schweitzer, RN, APN, CCNS, CCRN)
      • Sepsis Survival for Patients and Nurses (Alexander Johnson, MSN, RN, CCNS, ACNP-BC, CCRN)

We showcased our full line of safety and infection control products, including the DualCap® Disinfectant Cap, as well as our hemodynamic portfolio, including the DTXPlus® Blood Pressure Monitoring System, the SafeDraw Closed Loop Blood Sampling System, and the accessories that go with them.  You can learn more about these products and download brochures:

DualCap: https://www.merit.com/cardiac-intervention/solutions/infection-control/dualcap/
DTXPlus: https://www.merit.com/cardiac-intervention/critical-care-solutions/

In addition to discussing Merit Critical Care products, Merit Representatives in attendance at NTI also enjoyed visiting with hundreds of nurses to gather feedback about future products and innovations that we may be able to develop to support your needs at your hospitals.

Our first NTI was a memorable and fun experience. We thank all those nurses who made a stop at the Merit Medical Booth. It was impressive to see the level of sincere concern that you have for the health and safety of your patients. Our critical care and safety products provide continuity across the patient-care continuum, supporting the nurses we care about so much!

Merit Introduces InQwire® Amplatz Diagnostic Guide Wire

Elevate the Fine Art of Navigation

The right guide wire accomplishes many things. It can serve both diagnostic and interventional purposes. The right guide wire is versatile and facilitates procedures of various clinicians, including interventional radiologists, interventional cardiologists, vascular surgeons, and interventional nephrologists. But most of all, the right guide wire can help you get the job done.

That’s why Merit Medical is proud to launch the InQwire® Amplatz diagnostic guide wire.

Choosing the right guide wire starts with familiarizing yourself with its performance characteristics. The InQwire Amplatz guide wire is held at a very high standard by six pillars of performance:

Stiff Shaft Construction

Stiff guide wires provide the support needed to introduce catheters and other devices during procedures. Available in multiple lengths, the InQwire Amplatz’s larger inner core wire provides additional stiffness, which improves stability of devices within the vessels and enhances navigation of the devices throughout the vasculature. The InQwire Amplatz delivers push and navigation without compromising tip flexibility.

Multiple Tip Configurations

Tip flexibility means more tip configuration options to help navigate through tortuous anatomy. InQwire Amplatz’s straight tip wires are available in a variety of flexible profiles, including 1.0 cm, 3.5 cm, 4.0 cm, 6 cm, 7 cm, and J3 mm configuration.

Atraumatic Tip Design

The combination of the smooth transition of the distal weld joint, and the soft flexible atraumatic tip assists with negotiation of the most difficult anatomy.

Improved Lubricity

The InQwire Amplatz goes even further to support manipulation and advancement of catheters and other devices through the vessels with its proprietary PTFE coating. This feature provides improved lubricity along the entire wire surface, ensuring smooth manipulation throughout the vasculature. Data show Merit’s InQwire Amplatz is 20% more lubricious than the leading competitor.*

Device Placement Support

Not only does the lubricious coating help smooth advancement of devices through vessels, it reduces friction along the wire. Combined with this special coating, added stiffness provides extra support to facilitate advancement of devices, stability during device placement, and with exchanges during contralateral access. Highly-radiopaque material supports visibility.

Compatibility

The InQwire Amplatz is compatible with 0.035 in. and 0.038 in. devices, translating into more device options for your procedures.

And if all of these product benefits aren’t enough, Merit offers an extensive product offering to meet the needs of your most complex procedures.

Now that you’re familiar with all of InQwire Amplatz’s advantages, ask yourself:

Does your guide wire do that?

* Data on file   703991001/A

June 2017 ThinkHeRO: Gain hands-on experience with the HeRO® graft at the World-Class MITIESM Lab

Have you signed up for the June ThinkHeRO course yet? If you haven’t, you’ll want to because June’s training is the last ThinkHeRO course held in 2017 at the world-class Houston Methodist Institute for Technology, Innovation & Education (MITIESM).

What does this mean for you if you attend June’s ThinkHeRO training?

HeRO graft training at MITIE means you’ll have the opportunity to learn cutting-edge skills and have access to the latest technologies that will help support the advancement of your interventional and surgical procedures. June’s ThinkHeRO course is like no other because you’ll have the opportunity to rehearse, perfect, and perform techniques using cadavers in a state-of-the-art cadaver lab. Broken up into two groups for more individualized instruction, skills training such as placing a new implant, revising an existing implant, placing the venous outflow component from different access sites, identifying the anastomosis and tunneling will be addressed. These topics will be put into practice again in the SIM Lab using MITIE’s advanced training models.

Clinical discussions will also be taking place throughout the course that focus on HeRO graft tips, troubleshooting, and clinical guidelines. You’ll be invited to dive into several case study discussions with other physicians, enabling you to familiarize yourself with HeRO clinical scenarios that will help prepare you for challenging cases. At the end of the training, you’ll also receive help on how to build your own HeRO program.

One more reason you’ll want to reserve your seat for June’s ThinkHeRO course is that you’ll be taught by one of ThinkHeRO’s foremost leaders, Eric Peden, MD, Chief of Vascular Surgery at Methodist DeBakey Heart and Vascular Center. Dr. Peden has a rich history as both a surgeon and an instructor with vast experience and expertise that he’ll share with ThinkHeRO attendees. As the recipient of multiple accolades, Dr. Peden has been awarded the A.O.R.N. Distinguished Surgeon Award and Attending Teaching Award (Vascular Surgery Fellows). His stellar background also includes instructing at Baylor College of Medicine as Assistant Professor of Vascular Surgery before joining Methodist as Assistant Professor of Cardiovascular Surgery.

Visit us at https://www.merit.com/education/course_dates/#Hero and sign up today to be part of June’s special ThinkHeRO training held at MITIE. We look forward to seeing you there!

Your Safety Is Our Priority: Merit to Showcase Safety Products at NTI 2017

Thirty years ago, Merit Medical pioneered a clear-as-glass polycarbonate syringe to reduce the risk of a glass syringe breaking in the hand of a healthcare provider. Since our beginning, we’ve consistently prioritized solutions to procedural challenges, with the goal of making patient care safer for medical professionals like you.

Keeping up with this tradition, we’re excited to showcase our innovative safety products at the AACN’s National Teaching Institute & Critical Care Exposition (NTI) in Houston, TX, May 23-25.

Come to Booth 4300 to get an up-close look at Merit’s innovative safety products:

The DualCap System™

The DualCap System is a uniquely designed disinfecting cap system for use on both the male luer connector at the end of the IV tubing and the needle-free valve. The DualCap System consists of two caps designed to help prevent intraluminal contamination, as well as device cross-contamination.

MiniStop® Disposal Systems 

MiniStop Disposal Systems have a seal-tight lid to prevent fluid leakage after a procedure, providing quick and safe fluid waste elimination.

ShortStop® Temporary Sharps Holder 

Merit’s ShortStop was designed to prevent sharps injuries to both the clinician and the patient. With its distinctive bullseye design, the ShortStop holds needles and scalpels in a protected environment before, during, and after procedures.

BackStop® Disposal Systems

Our BackStop Disposal Systems have a seal-tight lid to prevent fluid leakage after a procedure, providing quick and safe fluid waste elimination.


Futura® Safety Scalpels

Protecting clinicians and patients, the Futura Safety Scalpel has spring retraction technology to minimize the risk of accidental cuts. Its one-handed activation combines convenience and rapid response for any surgical procedure.


Medallion® Syringes 

Medallion syringes are designed to facilitate compliance with national safety goals that require labeling of all medications on and off the sterile field. Available in seven color options with custom printing or a frosted field for writing information directly, Medallion Syringes take the guesswork out of medication labeling.


PAL™ Pen & Labels

Merit Medical’s PAL – Pen and Labels – were designed to streamline and help make labeling medication easier. PAL labels are designed to stick even when wet and can be customized with a variety of color choices for safety and convenience. The PAL pen is sterile, has a fine point, and is smear resistant.


DriPAD™ 

The DriPAD is a super absorbent pad that controls, isolates and traps biofluids while also containing and preventing the spread of odors. This premium pad can absorb up to 35x its weight in fluids, making them more efficient than the leading absorbent pad on the market. That’s up to 10x more absorption power than alternative pads!* Stop by Booth 4300 to learn about the DriPAD’s environmental, clinical, and financial advantages.


DTXPlus®

Safedraw arterial blood sampling systems are designed to reduce unnecessary blood discard and blood spillage. The system’s self-sealing, silicone septum facilitates easier blood sampling for clinical testing.


Merit Advance® Angiographic Safety Needles

The unique design of the Merit Advance Safety Needle allows clinicians to easily activate a low profile safety mechanism, shielding the needle bevel after use. The hub of this introducer needle is transparent for visibility and designed with an ergonomic feel for ease of handling.

 

Don’t forget about our in-booth presentations! Combining safety technology with education, Merit is hosting expert critical care nurses to address bloodstream infection prevention and treatment of SEPSIS:

Sepsis Survival for Patients and Nurses

Addressing the new definition of sepsis and mandatory CMS reporting.

Alexander Johnson, MSN, RN, ACNP-BC, CCNS, CCRN 

TUESDAY, MAY 23

10:45 am to 11:15 am
11:30 am to 12 noon
1 pm to 1:30 pm

Preventing CLABSIs: Tales from the Frontline

Discussing protocols to prevent bloodstream infections and how newer technologies and education have helped reduce the occurrence. A specific case will be discussed.

Donna Schweitzer, MSN, CCNS, CCRN 

WEDNESDAY, MAY 24

10:45 am to 11:15 am
11:30 am to 12 noon
3:15 pm to 3:45 pm

Click here to learn more about Merit’s NTI events, our expert critical care speakers, and to get a full list of other Critical Care and Infection Control products we’ll be showcasing.

*Data on file 

For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

Expert panel to discuss Interventional CRT Implant Techniques at the Rhythm Theater during HRS 2017

Merit Medical and Discover Interventional CRT would like to invite physicians attending HRS 2017 to save space on their program schedules for an invaluable presentation on Thursday, May 11th from 3:15-4:15pm in Rhythm Theater #2 titled, Interventional CRT Implant Techniques.

Leading the lecture are some of the field’s top electrophysiologists: (Chair) Kenneth A. Ellenbogen, MD, of Medical College of Virginia/VCU School of Medicine in Richmond, VA.; Jagmeet P. Singh, MD, DPhil, of Massachusetts General Hospital Heart Center in Boston, MA.; Seth Worley, MD, of MedStar Washington Hospital Center in Washington, DC; and Kevin Jackson, MD, of Duke University Medical Center in Durham, NC.

Interventional CRT Implant Techniques will explore how these leading physicians are utilizing interventional techniques to overcome difficult anatomy during LV lead placement. Experts will share clinical experience, novel approaches, and discuss whether anatomy or electrical timing should determine LV lead location. For more information about this timely event, please visit https://www.merit.com/hrs2017/. We look forward to seeing you there!

NTI 2017: Partner with Us Across the Patient Care Continuum

Merit Medical is making its debut at the 2017 AACN’s National Teaching Institute & Critical Care Exposition (NTI) in Houston, TX, on May 23-25. After 30 years of bringing quality, innovative products to medical professionals, we’re continuing the Merit tradition at this year’s NTI by introducing our critical care portfolio and demonstrating how we can partner with you across the patient care continuum.

Visit us at Booth 4300 and look forward to the following events we have planned through our Merit Education Theater:

  • Earn CERP credits while learning about infection control from expert critical care nurses.
  • Get an up-close look at our Critical Care and Infection Control products.
  • Learn about our Patient Care Continuum promise to you and product continuity that spans the patient care continuum.
  • Meet the Merit team at the Merit Ice Cream Café! Enjoy ice cream on us and learn about the many ways we can partner with you.

In-Booth Presentations You Won’t Want to Miss (Booth 4300):

Sepsis Survival for Patients and Nurses
Addressing the new definition of sepsis and mandatory CMS reporting.
Alexander Johnson, MSN, RN, ACNP-BC, CCNS, CCRN 

TUESDAY, MAY 23
10:45 am to 11:15 am
11:30 am to 12 noon
1 pm to 1:30 pm

Preventing CLABSIs: Tales from the Frontline
Discussing protocols to prevent bloodstream infections and how newer technologies and education have helped reduce the occurrence. A specific case will be discussed.

Donna Schweitzer, MSN, CCNS, CCRN 

WEDNESDAY, MAY 24
10:45 am to 11:15 am
11:30 am to 12 noon
3:15 pm to 3:45 pm

Learn more about Merit’s NTI events, our expert critical care speakers, and specific Critical Care and Infection Control products we’ll be showcasing.

Alicia Armeli is a paid consultant of Merit Medical. For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

Featuring the HeartSpan® Fixed Curve Transseptal Sheath at HRS 2017

Our excitement for HRS 2017 is building because it means we’re getting closer to showcasing some of our most exciting products.

One highly anticipated product, The HeartSpan® Fixed Curve Transseptal Sheath, is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. Available in a kit that contains a sheath, a dilator, and a J-tipped guidewire, the HeartSpan is designed for seamless dilator to sheath transition for ease of insertion and to reduce trauma when crossing the atrial septum.

To facilitate access to a variety of cardiac structures and sites, the sheaths are available in various sizes, lengths, and tip curve configurations—including the NEW ML1 and ML0 curves with intended anterior to lateral and superior to lateral positions, respectively. Both of these curves can be used as possible pulmonary vein isolation (PVI) ablation targets.

Other key features include:

  • Integrated Hemostatic Valve
    Designed to reduce air introduction and backflow
  • Lubricious Coating
    Reduces friction when exchanging electrophysiology (EP) catheters
  • Radiopaque Dilator
    Enables visualization

To learn more about the HeartSpan and its many product features, stop by booth 1549 for hands-on demonstrations of all Merit EP products.  For a schedule of all educational opportunities offered by Merit Medical at the upcoming HRS2017, visit Merit.com/HRS2017.

We are looking forward to seeing you there!

Alicia Armeli is a paid consultant of Merit Medical. For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

ThinkRadial and Merit Medical are Honored to Have Dr. Ferdinand Kiemeneij Co-Proctor this Week’s ThinkRadial™ Education

Today is the first day of our April ThinkRadial™ course and we couldn’t be more excited to have Guest of Honor Dr. Ferdinand Kiemeneij, MD, PhD, co-proctoring the IR and Advanced IC sections.

Dr. Kiemeneij is working side-by-side with co-proctors Sandeep Nathan, MD, MSc, FACC, FSCAI, interventional cardiologist at the University of Chicago Medical Center in Chicago, Ill., and Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, interventional radiologist at Vancouver General and UBC Hospitals in Vancouver, Canada.

Read the full article over at ThinkRadial.com

Join Us At HRS 2017!

Merit Medical and Discover Interventional CRT are pleased to announce training opportunities at HRS 2017. From May 10-12 in Chicago, Ill., HRS attendees can learn techniques and technologies from some of electrophysiology’s foremost leaders. Here’s a preview of what you can expect:

Thursday, May 11

LV Lead Delivery: Providing Options with a Simplified Approach
Booth 1549
9:45-10:15am
In-booth presentation by Dr. Seth Worley of MedStar Washington Hospital Center in Washington, DC. Dr. Worley will be available throughout the day for hands-on training.

Rhythm Theater—Interventional CRT Implant Techniques
Rhythm Theater #2
3:15-4:15pm
Dr. Kenneth A. Ellenbogen of Medical College of Virginia/VCU School of Medicine with expert panel discuss how leading physicians are utilizing interventional techniques to overcome difficult anatomy during LV lead placement.
Want more information?

Friday, May 12 

In-Booth Meet the Experts Hands-on Training
Booth 1549
9:30-10:30am and 3:00-4:30pm
Attendees have two opportunities to meet with interventional CRT experts as they share their advanced techniques for LV lead placement.

Throughout HRS, attendees will also get hands-on demonstrations for Merit EP products, including the new ML1 and ML0 HeartSpan® Fixed Curve Transseptal Sheath shapes. For more information about this year’s HRS schedule, visit https://www.merit.com/hrs2017/

10 Reasons Why IR’s and IC’s Should Attend April’s ThinkRadial™ Course

By Alicia Armeli

Twenty-five years ago, the first transradial coronary intervention was performed. This sparked the start of the Radial Revolution—a medical movement that put transradial procedures on the map as a way of treating patients without surgery. In honor of this progress, Merit Medical is hosting a special ThinkRadial® course April 21-22 for Interventional Radiologists and Interventional Cardiologists. Here’s why you won’t want to miss it.

  1. Get a Front-Row Seat to Learn from the Father of Transradial Intervention

For the first time, Merit is honored to have the “Father of Transradial Intervention” himself—Dr. Ferdinand Kiemeneij—as the special guest of honor at a US ThinkRadial course. In 1992, Dr. Kiemeneij was the first to perform a transradial coronary intervention at the Onze Lieve Vrouwe Gasthuis in Amsterdam. Attendees will be able to learn from Dr. Kiemeneij’s knowledge, expertise, and technique as he co-proctors this one-of-a-kind training opportunity. Read more about Dr. Kiemeneij in this special News Blog.

  1. Stellar Proctors: a Chance to Be Trained by the Best

Alongside Dr. Kiemeneij, well-known physicians who are experts in the transradial technique will be proctoring attendees. Interventional Radiologist Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, of Vancouver General and UBC Hospitals will be instructing Interventional Radiologists, while Sandeep Nathan, MD, MSc, FACC, FSCAI, of the University of Chicago Medical Center will be training Interventional Cardiologists.

  1. New Advanced Interventional Cardiology Curriculum

To help Interventional Cardiologists advance to the next level of transradial, for the first time, the April ThinkRadial program features an Advanced Curriculum for Interventional Cardiologists. IC attendees will be able to share and troubleshoot complex cases, learn advanced transradial techniques, and hear an invaluable presentation by Dr. Kiemeneij about new radial techniques and advancements in the field.

  1. True Hands-On Experience

Interventional Radiologists will have the opportunity to learn the radial technique through direct experience using cadavers, while Advanced Interventional Cardiologists will gain hands-on practice using ultrasound-guided access on realistic arm models.

  1. Beginner Interventional Radiologists Welcome

Everyone must start somewhere! Merit invites Interventional Radiologists with little to no transradial experience to the training course, as well as those wanting to improve their technique. Introductory information, including patient prep and room set-up, will be presented.

  1. Gain Knowledge By Learning From Each Other

Each advanced Interventional Cardiology attendee will present his/her own complex case for discussion and team troubleshooting. Learning from fellow Interventional Cardiologists can help you better understand potential complications and how to navigate them successfully.

  1. Look Ahead

Physicians attending the course will learn how to implement the procedure in more complex interventions, expanding your ability to use the transradial approach in more situations. In addition, Dr. Kiemeneij will present new transradial techniques that demonstrate what’s coming down the pipe!

  1. Visit Salt Lake City and See Where Merit Does Its Magic

The ThinkRadial course will be held in beautiful Salt Lake City, Utah, at the Merit Medical Education Center.

  1. Networking

This training event includes a group dinner where attendees can meet and greet each other, as well as listen to a memorable presentation by Dr. Kiemeneij.

  1. It’s On Us

Merit Medical will pay or reimburse for certain travel and other expenses associated with attending this program in accordance with the AdvaMed Code of Ethics and will appropriately disclose per the Sunshine Act. Travel and reimbursement information will be provided during the registration process.

To learn more about registration, visit Merit.com/Education. We hope to see you there!

Alicia Armeli is a paid consultant of Merit Medical. For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

Want to Learn More About Transradial Access?

Two of the Leaders in IR Transradial Access Invite Interventional Radiologists to Attend a Special “Intro to Transradial” Dinner Event

By Alicia Armeli

On Monday, March 27, 2017, from 6-9p at Ristorante Morini in Midtown, NYC, Merit Medical and ThinkRadial™ will host a special “introduction to transradial” dinner event to promote clinical benefits and present introductory training information to interventional radiologists. A uniquely beneficial learning opportunity, attendees will have the chance to listen to well-known interventional radiology radialists, Dr. Aaron Fischman of Mount Sinai in NYC and Dr. Darren Klass of Vancouver General and UBC Hospitals in Vancouver, Canada, as they give informational didactic presentations over dinner.

Topics for discussion will include the clinical benefits of transradial access and fundamental tips to get started, such as case selection, patient prep, room setup, catheter selection, and hemostasis. What’s more, Dr. Fischman and Dr. Klass will share their expertise by offering a valuable Q & A radial panel discussion.

Aaron Fischman, MD, is the Director of Vascular and Interventional Radiology at The Mount Sinai Health System and Associate Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai. He is also Associate Professor of Radiology and Surgery in the Division of Vascular and Interventional Radiology at The Mount Sinai Medical Center. A leader of the transradial technique, Dr. Fischman has led the way using transradial for oncologic liver interventions and uterine fibroid embolization. Dr. Fischman has shared his knowledge and experience by authoring and co-authoring many peer-reviewed publications and lecturing worldwide about novel techniques for minimally invasive interventions.

Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, is an interventional radiologist at Vancouver General and UBC Hospitals in Vancouver, Canada. He performed the first transradial radioembolization and chemoembolization of the liver in Canada and is developing a robust hardware platform for radial access to the liver. His practice is 90% radial for liver interventions and fibroid embolization.

This one-of-a-kind dinner event is open to interventional radiologists who want to learn the basics of transradial access and how to get started. Merit representatives will also be available to answer any “next-step” questions physicians may have. Seating is limited!
RSVP today at Merit.com/Education

Alicia Armeli is a paid consultant of Merit Medical. For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

“Father of Transradial Intervention,” Ferdinand Kiemeneij, MD, PhD, to be the Special Guest of Honor and Co-Proctor for Upcoming ThinkRadial™ Education Program in April

By Alicia Armeli

In order to keep up with the growth and progress of interventional medicine, Merit Medical is hosting a dynamic ThinkRadial™ training course on April 21-22 at Merit Medical headquarters in Salt Lake City, Utah. For the first time in the US, world-renowned Interventional Cardiologist Ferdinand Kiemeneij, MD, PhD, will be attending as the special guest of honor, co-proctoring the interventional radiologist and brand new advanced interventional cardiologist courses, lecturing at both training sessions.

Recognized as the “Father of Transradial Intervention,” Dr. Kiemeneij first began applying transradial access to angioplasty and stent placement procedures as early as 1992. This led to stenting on an outpatient basis in 1994. Since then, Dr. Kiemeneij has been lecturing and teaching physicians the transradial technique, as well as its many advantages over transfemoral access. More than two decades later, the European Society of Cardiology (ESC) gave the transradial approach the highest degree of recommendation over transfemoral access for coronary angiography and Percutaneous Coronary Intervention (PCI) in patients with Acute Coronary Syndromes (ACS).1

Sought after worldwide, Dr. Kiemeneij was invited in 2013 to build an intervention program at the Tergooi Hospital in The Netherlands. The author of numerous clinical articles and a 2016 book entitled, Transradial Coronary Interzentions, Dr. Kiemeneij has built his practice by combining writing, proctoring, lecturing, and training fellow physicians the world over.

Dr. Kiemeneij will co-proctor advanced interventional cardiologist attendees with venerated Interventional Cardiologist Sandeep Nathan, MD, MSc, FACC, FSCAI, of the University of Chicago Medical Center in Chicago, Ill. He will co-proctoring the interventional radiologist portion with esteemed Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, Interventional Radiologist at Vancouver General and UBC Hospitals in Vancouver, Canada. Dr. Kiemeneij will also share his knowledge and expertise during the groups’ hands-on trainings. Following the Friday sessions, Dr. Kiemeneij will give an invaluable presentation at a special group dinner event.

Space for this program is limited. To submit your interest in this upcoming Think Radial training course and learn from the “Father of Transradial Intervention,” talk to your Merit Representative or visit Merit.com/Education.

Alicia Armeli is a paid consultant of Merit Medical. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

  1. European Society of Cardiology. (2015). ESC Guidelines Recommend Radial Approach for Percutaneous Coronary Interventions in ACS. Retrieved February 11, 2017, from http://www.escardio.org/The-ESC/Press-Office/Press-releases/esc-guidelines-recommend-radial-approach-for-percutaneous-coronary-interventions-in-acs

Eric Peden, MD, Leads Think HeRO Graft Training Course

By Alicia Armeli

Eric Peden, MD

March 30-31 marks the start of this year’s Think HeRO Graft™ training courses. Held at the Houston Methodist Institute for Technology, Innovation & Education (MITIESM), the course will be led by HeRO® Graft pioneer Eric Peden, MD.

One of Houston’s own, Dr. Peden is Chief of Vascular Surgery at Methodist Cardiovascular Associates, Methodist Hospital at the Texas Medical Center in Houston, Texas. He also serves as Assistant Professor of Cardiovascular Surgery at the Institute for Academic Medicine—Houston Methodist and Weill Cornell Medical College in New York City, NY. Previous to these posts, Dr. Peden was an Assistant Professor of Vascular Surgery at Baylor College of Medicine.

Dr. Pedens experience with the HeRO Graft goes back over a decade. One of its principal investigators, Dr. Peden was one of the first to research the outcomes of HeRO Graft use in access-challenged patients with venous obstruction. His passion and dedication in the field of peripheral vascular disease continues as he currently oversees various ongoing outcomes projects and is principal investigator for multiple clinical trials.

At the top of his field in both surgery and instruction, Dr. Peden is a Fellow of the American College of Surgeons (FACS) and received the A.O.R.N. Distinguished Surgeon Award in 2008 and Attending Teaching Award (Vascular Surgery Fellows). In other leadership roles, he was elected to the Board of Directors of VASA in 2013, has served as a VASA Practicum lecturer, and a regular speaker at SVS and ASDIN.

Register now because space is limited! To participate in this upcoming Think HeRO Graft training course and learn from Dr. Peden himself, talk to your Merit Representative or visit Merit.com/Education.

Alicia Armeli is a paid consultant of Merit Medical. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

#NextGenRadial Provides Tools and Skills Clinicians Need for Transradial Access

By Alicia Armeli

For well over a decade, transradial access has been used for coronary interventions. In comparison to the transfemoral approach, research has linked transradial with increased patient preference and fewer vascular complications.1,2 A more cost-effective approach that has success rates similar to the transfemoral technique, transradial access is expanding into other fields of medicine.3,4

Once reserved as an alternative mode of arterial access, the interventional radiology community is now debating whether radial artery access could provide higher patient care value under the “best practices” concept.5 With the growing number of physicians choosing transradial for interventional coronary and radiology procedures, Merit Medical has developed #NextGenRadial—the only second generation of radial products on the market. Combined with their innovative hands-on ThinkRadial™ training courses, Merit provides the skills and tools physicians need to launch new radial practices or successfully bring existing practices to the next level.

The femoral artery has been the traditional access point for the majority of interventional procedures, but a recent notable shift has taken place. Just last year, the European Society of Cardiology (ESC) gave the radial approach the highest degree of recommendation over femoral access for coronary angiography and Percutaneous Coronary Intervention (PCI) in patients with Acute Coronary Syndromes (ACS).6

“New data shows that the radial approach is superior to the femoral not only in terms of vascular complications and major bleeding events but also in reducing all-cause mortality,” said Professor Marco Roffi (Switzerland), Task Force Chairperson in an ESC press release. “It is recommended that centers treating ACS patients implement a transition from transfemoral to transradial access.”6

To demonstrate its superiority, multiple studies have emerged. The well-known MATRIX Study, a 2015 randomized multicenter trial by Valgimigli et al. compared radial with femoral access in patients with ACS with or without ST-segment elevation myocardial infarction and who were about to undergo coronary angiography and PCI.7 Consisting of 8,404 patients, results showed fewer adverse events among those who underwent the transradial approach (9.8% or 410) in comparison to those who underwent transfemoral (11.7% or 486).

Given these results, the authors of the study concluded that “radial as compared to femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality” and that transradial access should be the “default approach in patients with an acute coronary syndrome undergoing invasive management.”7 Other randomized investigations provide data that show transradial access to be associated with shorter hospital stay.8 The 2011 multicenter RIVAL trial showed transradial access to be patient-preferred, with 90% of those who underwent the transradial approach designating it as their access site of choice if they needed another procedure.1

Patients undergoing transradial non-coronary interventions are also seeing benefits. A 2015 feasibility study by Posham et al. reported that transradial access was well tolerated among patients receiving a range of peripheral vascular interventions, including chemoembolization, visceral intervention, and uterine artery embolization.9 In this single-center review, 936 patients were evaluated for 1,512 transradial noncoronary procedures between April 2012 and July 2015. Results published in the Journal of Vascular and Interventional Radiology showed transradial access to have a technical success rate of 98.2%. Major complications and minor complications were minimal at 0.13% and 2.38% respectively. A total of 27 cases (1.8%) required crossover to transfemoral access.

Taking patient and clinician safety a step further, a superiority study by Khayrutdinov et al. showed that utilizing the radial technique for UFE and PAE led to reduced procedural time, thereby minimizing radiation exposure.10

From a cost benefit standpoint, the transradial approach can save money. In 2013, Amin et al. published results of a multicenter study that evaluated costs of transradial and transfemoral PCI from a contemporary hospital perspective.3 Over 7,000 procedures were performed between January 2010 and March 2011. Of these, 17% of patients underwent the transradial approach. In comparison to transfemoral, transradial was associated with shorter hospital stays (2.5 vs. 3.0 days) and fewer bleeding events (1.1% vs. 2.4%).  Total cost savings for transradial access was $830 per patient, of which $130 were procedural savings and $705 were post procedural savings. Even greater savings were seen in high-risk patients.3

Despite these findings, only 20% of interventional procedures in the US are performed via transradial access.11 Low adoption of the transradial approach may be related to challenges learning the technique. And yet, data taken from the CathPCI Registry demonstrate that operator proficiency improves with greater transradial experience. Despite the learning curve of about 30 to 50 cases, patient safety is still maintained with high procedural success and low rates of mortality, bleeding, and vascular complications.12

As awareness of the radial technique increases among patients and physicians, Merit has developed the renowned ThinkRadial training program in an effort to provide comprehensive exposure to the next generation of transradial operators. Getting its start in 2014, ThinkRadial invited the best and brightest to spearhead the course. Leading the Interventional Cardiology Courses is Sandeep Nathan, MD, MSc, FACC, FSCAI, an Associate Professor of Medicine and Medical Director of the Cardiac Intensive Care Unit at the University of Chicago Medical Center, where he also serves as the Co-Director of the Cardiac Catheterization Laboratory and Director of the Interventional Cardiology Fellowship Program.

In 2015, Merit extended its cutting-edge ThinkRadial course to interventional radiologists by bringing on Interventional Radiology ThinkRadial Course Director Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, an Interventional Radiologist at Vancouver General and UBC Hospitals, and head of the MRI Division for Vancouver Acute in Vancouver, Canada. Well-known across borders, Dr. Klass performed the first transradial radioembolization and chemoembolization of the liver in Canada.

Throughout the program, ThinkRadial attendees are split into cardiology and radiology specific tracks, but also have several opportunities to learn from each other as a combined group. In their specific tracks, they participate in didactic presentations and discuss taped cases that cover a range of topics, including patient selection, access technique, and potential complications. What’s more, hands-on training with cadavers and simulation training models provide physicians at every level of experience with radial solutions needed for their own practice.

“After attending the ThinkRadial course, I had all the tools I needed to begin transitioning my practice to radial,” said Shivank Bhatia, MD, Interventional Radiologist at the University of Miami Health System, and ThinkRadial Alumni, January 2016. “My first case post ThinkRadial was supported by Merit Medical; their reps did a great job with in-service for the entire support staff, making the introduction of radial products seamless. Using a radial approach has led to great patient experiences, reduced procedure time and overall improved patient satisfaction. I intend to be “radial first” within the next six months to one year.”13

Crossing continental lines, ThinkRadial courses are offered in Europe, South Africa, South America, and Asia—in addition to the US courses offered both at Merit Medical’s Utah headquarters and regionally.

The Course Directors emphasize providing a full radial “education,” as opposed to just a training, so that attendees have the knowledge they need to personalize the experience once they head back to their practice. “The class provided me with a template approach but the foresight to adapt the training to my practice as I saw fit,” explained Mohammad A. Bilal, MD, DABR, Director of Vascular and Interventional Radiology at John T Mather Memorial Hospital, Port Jefferson in Long Island, NY, and ThinkRadial Alumni, April 2016. “I was most excited to leave with the proper set of tools to implement the approach.”13

To fully equip this next generation of experts, Merit provides one-of-a-kind #NextGenRadial products to facilitate each step of transradial access.

Set-up: Merit Rad Board® and Accessories

The reusable Rad Board fits all cath lab and radiology procedure tables and is reversible for right- or left-side access—making it an economical choice.  Putting safety first, a section of Xenolite TB is embedded in the Rad Boards and has shown to help reduce radiation scatter exposure levels by up to 44% at waist height and up to 25% at neck height, according to an independent survey.* Convenient uprights on the sides form a reservoir with the drape to keep devices and fluids on the board. Cutout handles allow for convenient moving and transport.

Each Rad Board accessory—Rad Board Xtra™, Rad Trac™ and Rad Rest®—provide additional support for radial access procedures. The Rad Board Xtra allows for 90° perpendicular extension of the arm during access, while the Rad Trac encourages easy placement of the Rad Board when the patient is on the table. The soft Rad Rest arm cushion boosts patient comfort by providing ergonomic wrist and elbow support during radial access procedures.

Access: PreludeEASE™ Hydrophilic Sheath Introducers

PreludeEASE is Merit’s newest line of Hydrophilic Sheath Introducers. Studies show that hydrophilic coating on sheath introducers can reduce the incidence of artery spasm and improve patient comfort during transradial diagnostic and interventional coronary procedures.14

PreludeEASE kink-resistant tubing helps to provide procedural reliability. Smooth transitions between wire to dilator and dilator to sheath were designed for ease of insertion and can help enhance patient comfort. Available in 4F through 7F diameters and multiple lengths, PreludeEASE anticipates various clinical needs and diverse patient anatomy without compromising its slim profile and large inner diameter.

Diagnostics: Performa® Diagnostic Cardiology Catheters

Merit’s Performa diagnostic cardiology catheter is designed with improved shaft strength for better pushability and torque. Made from Nylon Pebax® material selected to give the Performa improved kink resistance, its flat-wire braid design offers greater stability and increased torque. A large inner lumen enables increased flow rates. The Performa’s winged polycarbonate hub offers enhanced handling and control and the radiopaque tip allows shaft visualization under fluoroscopy to ensure accurate placement. Anticipating individual patient needs, Merit’s diagnostic catheters come in radial specific shapes and lengths. Also available is the Performa Multipack, which combines all three typical workhorse catheters in one convenient package.

Hemostasis: Safeguard Radial™ Compression Device

The Safeguard Radial Compression Device is a 26-cm long self-adhesive wristband designed to assist with hemostasis following radial access procedures. The band allows for adjustable compression of the radial puncture site with an inflatable bulb and standard Luer valve for easy inflation and deflation with any standard Luer syringe.

A clear window allows for better visualization of the puncture site and the size and shape of the bulb minimizes compression of surrounding nerve structures or other areas. The one-size-fits all cloth wristband offers greater patient comfort and fits securely around the wrist.

Through evidence-based data, education, and products, Merit Medical’s #NextGenRadial toolkit provides physicians with the skills, products—and above all—the confidence they need to take full advantage of the radial approach. A technique where the data speaks for itself, radial access is no longer the future of medicine—but the present. Will you be part of the Next Generation?

Alicia Armeli is a paid consultant of Merit Medical. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

 

REFERENCES

  1. Jolly, S., Yusuf, S., Cairns, J., et al. (2011). Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. The Lancet, 377(9775): 1409-1420. doi: http://dx.doi.org/10.1016/S0140-6736(11)60404-2
  2. Feldman, D., Swaminathan, R., Kaltenbach, L., et al. (2013). Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention—an updated report from the National Cardiovascular Data Registry (2007–2012). Circulation, 127: 2295-2306. doi: http://dx.doi.org/10.1161/CIRCULATIONAHA.112.000536
  3. Amin, A., House, J., Safley, D., Chhatriwalla, A., Giersiefen, H., Bremer, A., Hamon, M., Baklanov, D., Aluko, A., Wohns, D., Mathias, D., Applegate, R., Cohen, D., & Marso, S. (2013). Costs of transradial percutaneous coronary intervention. Journal of the American College of Cardiology Cardiovascular Interventions, 6(8): 827-834. doi: 10.1016/j.jcin.2013.04.014. https://www.ncbi.nlm.nih.gov/pubmed/23871512
  4. Rao, S., Ou, F., Wang, T., Roe, M., Brindis, R., Rumsfeld, J., Peterson, E. (2008). Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention—a report from the National Cardiovascular Data Registry. Journal of the American College of Cardiology Cardiovascular Interventions, 1(4). doi: 10.1016/j.jcin.2008.05.007. https://www.ncbi.nlm.nih.gov/pubmed/19463333
  5. Guimaraes, M., Tamada, R., Anderson, et al. (2016). Radial access for interventional radiology procedures. Just an alternative access or an excellent model aligned with the upcoming changes of the healthcare reform? Journal of Vascular and Interventional Radiology, 27(3): S47-S48. doi: http://dx.doi.org/10.1016/j.jvir.2015.12.133
  6. European Society of Cardiology. (2015). ESC Guidelines Recommend Radial Approach for Percutaneous Coronary Interventions in ACS. Retrieved November 14, 2015, from http://www.escardio.org/The-ESC/Press-Office/Press-releases/esc-guidelines-recommend-radial-approach-for-percutaneous-coronary-interventions-in-acs
  7. Valgimigli, M., Gagnor, A., Calabró, P., et al. (2015). Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. The Lancet, 385(9986): 2465-2476. doi: http://dx.doi.org/10.1016/S0140-6736(15)60292-6
  8. Romagnoli, E., Biondi-Zoccai, G., Sciahbasi, A., et al. (2012). Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. Journal of the American College of Cardiology, 60(24): 2481-2489. doi: 10.1016/j.jacc.2012.06.017. http://www.sciencedirect.com/science/article/pii/S0735109712023662
  9. Posham, R., Biederman, D., Patel, R., et al. (2016). Transradial approach for noncoronary interventions: a single-center review of safety and feasibility in the first 1,500 cases. Journal of Vascular and Interventional Radiology, 27(2): 159-166. doi: 10.1016/j.jvir.2015.10.026. https://3g6fc347p04i2t7uf32fjw56-wpengine.netdna-ssl.com/wp-content/uploads/2016/04/Posham-Fischman-TRA-Non-Coronary-Sinai.pdf
  10. Khayrutdinov, E., Arablinskiy, A., Vorontsov, A., Moscow/RU, & Omsk/RU. (2015). The Olbert International Radiology Symposium—The benefit of transradial artery approach in patients undergoing peripheral artery embolization. Retrieved November 14, 2016, from https://3g6fc347p04i2t7uf32fjw56-wpengine.netdna-ssl.com/wp-content/uploads/2015/01/IROS-2015.pdf
  11. Bilazarian, S. (2015). Medscape. Radial Access: Get Onboard or Get Left Behind. Retrieved November 16, 2016, from http://www.medscape.com/viewarticle/837729
  12. Hess, C., Peterson, E., Neely, M., et al. (2014). The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry. Circulation, 129(22): 2277-2286. doi: 10.1161/CIRCULATIONAHA.113.006356. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4048735/
  13. ThinkRadial Transradial Intervention Course. (Oct 2016). Attendee Testimonial.
  14. 14. Rathore, S., Stables, R., Pauriah, M., Hakeem, A., Mills, J., & Palmer, N. et al. (2010). Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention. JACC: Cardiovascular Interventions, 3(5): 475-483. https://www.ncbi.nlm.nih.gov/pubmed/20488402

*In-house data

Alicia Armeli is a freelance writer and editor who specializes in medical technology, health, and wellness.

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Merit’s Family of Drainage Products Supports Drainage Procedural Needs Every Step of the Way

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By Alicia Armeli

Proper drainage is necessary for the removal of fluid buildup, as well as diagnosis. From access to intervention, Merit Medical provides a diverse portfolio of drainage products to support procedural needs throughout each step. With products designed in multiple configurations for specific drainage needs and kits that can be tailored to meet clinical challenges head-on, Merit helps deliver patient-care that’s efficient, while still being cost-effective.

Merit’s MAK-NV™ Introducer System

At the start of every drainage procedure, avoiding delays and complications could be as simple as choosing the right introducer system. Merit’s MAK-NV™ Introducer System and Valve Adapter—for mini access in non-vascular applications—were designed to help circumvent clinical challenges, such as introducer tip peel-back, inability to determine the exact location of the introducer tip, and difficulty visualizing the needle tip. In doing so, the MAK-NV Introducer System makes for easy visualization that leads to quick access into the drainage area.

VALVE ADAPTER FOR MAK-NV™

Starting with a tapered dilator and introducer tip, the MAK-NV allows for smooth transitions and movement over the guide wire, which can help minimize buckling and the incidence of introducer peel back during insertion. Introducer systems without tapered tips may be more prone to catching on tissue, potentially leading to peel back. Once inserted, the MAK-NV Introducer System’s distally placed radiopaque marker tip can help to determine its precise location more easily. For better needle visualization, the MAK-NV Needle has 1 cm echo-enhancement also placed at the distal end. Other needles without echo-enhancement technology may not be as easy to visualize when using ultrasound imaging.

One-Step™ Centesis Catheters

Echo-enhancement can be beneficial, particularly during interventional centesis procedures. Pneumothorax is a common complication of thoracentesis. Yet, studies have shown that using real-time ultrasonography is a modifiable factor that reduces pneumothorax risk.1 Merit’s One-Step™ Centesis Catheters have echo-enhanced needles that aid with visualization when using ultrasound. What’s more, the Valved One-Step™ Centesis Catheter has a self-sealing valve to decrease the risk of pneumothorax, as well as prevent fluid leakage during centesis procedures. Both the One-Step and Valved One-Step Centesis Catheters employ a tapered tip for smooth transitions that can decrease resistance and patient discomfort. To maximize performance, each device is designed with large drainage holes and pigtail tips.

Valved One-Step™ Centesis Catheter

Merit drainage products reach beyond centesis procedures. For biliary and all-purpose drainage needs, the ReSolve® line of biliary, locking, and non-locking drainage catheters are designed to help lessen trauma to surrounding tissue, support more precise placement, and provide unimpeded drainage.

Biliary drainage procedures are associated with significant catheter-related complications that occur in up to 22% of procedures.2 A common complication of percutaneous biliary drainage is catheter obstruction—usually the result of bile stones, biliary sludge, blood clots, or intestinal debris.2  Bench top data show Merit drainage catheters to have larger drainage holes, faster flow rates, larger drainage area, and larger catheter inner diameters when compared to leading competitors.

ReSolve® Biliary Locking Drainage Catheters

These qualities can be observed in the ReSolve® Biliary Locking Drainage Catheters, which have multiple large holes laid out in two different drainage hole patterns to accommodate targeted drainage of various lesion locations, thus offering up to 4x more drainage area when compared to leading competitors. In combination with radiopaque marker bands, the ReSolve Biliary Locking Drainage Catheter also has depth markers to facilitate fast and accurate positioning. To increase patient comfort and avoid irritating surrounding tissue, the hydrophilic-coated tip of the catheter is located inside an atraumatic pigtail curve. The ReSolve Biliary Locking Drainage Catheter can either be locked to prevent movement, or unlocked to reposition the catheter. If needed, its polyurethane material allows for long-term indwelling time.

ReSolve® Locking Drainage Catheter

For all-purpose drainage needs such as nephrostomy procedures, Merit offers the ReSolve® Locking and Non-Locking line of drainage catheters. Featuring many of the same advantages as their biliary counterpart, ReSolve Locking and Non-Locking Catheters employ hydrophilic coating and tapered tips. The tip of the locking drainage catheter can be found inside a locking pigtail, while non-radiopaque depth markers on the catheter shaft act as a reference for correct positioning. Large drainage holes of locking catheters maximize percutaneous drainage.

To emphasize cost savings and time efficiency, Merit offers ReSolve+™ Biliary Locking Drainage Catheters and ReSolve+™ Locking Drainage Catheters. Both offer all the same clinical benefits of their parent ReSolve products but with fixation device options. Each come with either the Revolution™ Catheter Securement Device or the StayFIX® Fixation Device.

Revolution™ Catheter Securement Device

Fixation and securing devices can improve patient comfort by reducing irritation to tissue surrounding the catheter, as well as avoiding the potential for catheter dislodgment. The Revolution Catheter Securement Device is a needleless and economical product designed with patient and clinician safety in mind. Easily positioned, the Revolution Catheter Securement Device holds a catheter in place, leaving the insertion site visible for cleaning and monitoring.

Its sister product—the suture-free StayFIX Fixation Device—is made only for percutaneous non-vascular catheters. This cost-savings option is designed to stop catheter migration, movement, and accidental removal. Made of soft water-resistant material, StayFIX remains secure for up to 7 days, allowing for patients to shower without removing the device. Additionally, its hydrocolloid material can reduce skin irritation by absorbing any fluid leaking from the insertion site.

Working alongside Merit’s catheters are several more accessories that together aim to improve the overall patient experience and increase procedural efficiency.

VacLok® Vacuum Pressure Syringe

This includes innovative devices created for common difficulties clinicians face. For example, abscess drainage and thrombus aspiration are often associated with clinician hand fatigue. To avoid this challenge and associated procedural delays, Merit has developed the VacLok® Vacuum Pressure Syringe. The VacLok creates a sustained negative vacuum by pulling back on the plunger and locking the device in place. With a clear polycarbonate barrel available in several sizes, fluid can be continuously collected and its volume monitored.

Drainage Depot™ Drainage Bags

For procedures that don’t use syringes but collect fluid in drainage bags, Merit supplies Drainage Depot™ Drainage Bags along with adjustable length drainage tubing and a VELCRO® brand leg strap that can meet a variety of patient sizes. With easy-to read volume markings, a twist valve for tidy disposal, and an internal anti-reflux valve—Depot Drainage Bags assist in improving the drainage process.

Merit Marquis® Series Stopcock

Taking efficiency to another level, the Merit Marquis® Series Stopcock accessories provide an added element of control to catheter procedures. With a larger easy-to-hold handle, the Marquis is simple to use with an effortless grip and turn motion. Described as “a cut above the rest,” the Marquis Series Stopcock is available in different pressure ratings, luer options, and has a patented airless rotator that prevents air bubbles from forming.

ReSolve Locking Drainage Catheter Tray

To increase convenience of drainage procedures, Merit offers standalone drainage options, kit configurations, or procedural trays. The MAK-NV kit comes with a variety of needles and guide wires, along with a large diameter introducer. Examples of ready-to-use trays include the ReSolve Locking Drainage Catheter Tray, the Safety Paracentesis Procedure Tray, and the Thoracentesis & Paracentesis Set (TAPS). Each kit includes all the products needed to perform a corresponding drainage procedure—minimizing procedural delays, while still ensuring a safe working environment.

Each member of Merit’s drainage family works together to provide an integrative approach to drainage procedures. By understanding and supporting clinician needs, Merit can help you deliver patient-centered, efficient, and cost-effective care. Welcome to the family.

Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

REFERENCES

  1. Gordon, C., Feller-Kopman, D., Balk, E., & Smetana, G. (2010). Pneumothorax following thoracentesis: a systematic review and meta-analysis. Archives of Internal Medicine, 170(4): 332-339. doi: 10.1001/archinternmed.2009.548. https://www.ncbi.nlm.nih.gov/pubmed/20177035
  2. Huang, S., Engstrom, B., Lungren, M., & Kim, C. (2015). Management of dysfunctional catheters and tubes inserted by interventional radiology. Seminars in Interventional Radiology, 32(2): 67-77. doi: 10.1055/s-0035-1549371. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4447882/

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

A STAR™ Is Born: Spinal Tumor Ablation with Radiofrequency Significantly Reduces Pain Associated with Metastatic Spinal Tumors

STAR-header

By Alicia Armeli

Each year, 400,000 people in the US alone suffer from bone metastases.1 Frequently seen in the spine—and specifically in the vertebrae—spinal tumors make up 40% of all bone metastatic disease.2,3 Pain associated with this condition can be excruciating.

Merit Medical’s STAR™ Tumor Ablation System (Spinal Tumor Ablation with Radiofrequency)—a unique device designed for the palliative treatment of painful metastatic spinal tumors—has been found to significantly reduce patient reported pain, often decreasing the need for pain medications, and improving overall quality of life.3,4

Historically, treating patients with metastatic spinal tumors has been a challenge. Traditional pain management is a balancing act that involves pain control, local tumor control to avoid neurological damage, and mechanical stabilization to preserve function.2  Treatments include pain medicines, chemotherapy, radiation therapy, and/or surgery. However, surgery may be avoided due to coexisting health problems or diminished life expectancy.3

A minimally invasive alternative that has been found to successfully treat spinal metastatic lesions is targeted radiofrequency ablation with the STAR Tumor Ablation System. Recognized in version 2014 of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Adult Cancer Pain as an interventional strategy for treatment of local bone pain, radiofrequency ablation can provide rapid pain relief by localized tumor destruction—often in a single outpatient session.5

Anchala et al. conducted a multicenter retrospective study of the STAR Tumor Ablation System involving 92 patients with a total of 128 metastatic spinal lesions from five academic centers who underwent targeted radiofrequency ablation between March 2012 and March 2013.3 Results published in Pain Physician Journal reported all 96 procedures to be technically successful without complication or thermal injury. Average Visual Analogue Scale (VAS) Scores showed that reported pain reduced significantly from 7.51 out of 10 before the procedure to 1.73 post-procedure, which stayed consistent at 6 months (1.75).

What’s more, the authors noted that 54% of the patients participating at the largest center were able to decrease their pain medication dosage. At the same center almost two-thirds of the lesions treated with the STAR Tumor Ablation System were located in the posterior vertebral body—a location previously considered difficult to access. Post ablation images confirmed the size of ablation zones matched those measured with device feedback and showed no further growth or canal extension of treated tumor.

Also significant to note, the STAR Tumor Ablation System was able to treat these patients without having to interrupt their primary cancer treatment. “For late-stage cancer patients, extreme back pain due to spinal tumors degrades quality of life; and until now, limited minimally invasive procedural options for immediate pain relief have been available,” said Nam D. Tran, MD, PhD, a neuro-oncology surgeon at Moffitt Cancer Center, Assistant Professor of Oncology and Neurosurgery at the University of South Florida College of Medicine in Tampa, Fla., and co-author of the study. “This multi-center study validates t-RFA (targeted radiofrequency ablation) as a treatment option that provides rapid, lasting pain relief without the need to interrupt the patient’s primary cancer therapy.”6

The STAR Tumor Ablation System procedure begins with a small puncture at the desired access site and the SpineSTAR® device is inserted into the affected vertebra by way of a working cannula. Active steering capability of the ablation instrument allows for precise navigation through the pedicle and into the desired areas of the vertebra-containing tumor. Once in place, radiofrequency energy is emitted through a bipolar electrode resulting in thermal necrosis of the adjacent tissue while two thermocouples on the electrode simultaneously monitor the tissue temperature. This real time feedback gives physicians the control to create site-specific ablation zones. The radiofrequency energy administration is stopped once the proximal thermocouple measures 50°C . When clinically indicated, the SpineSTAR device allows for precise repositioning within the vertebral body to produce overlapping ablation zones.

An advantage radiofrequency ablation therapy has is that it’s effective on its own and can also be used in conjunction with other treatments. Whether this means patients can continue their prescribed cancer regimen uninterrupted—as noted in the aforementioned study—or as part of a synergistic approach to pain management, ablation has the advantage of flexibility. Coupling pain management therapies can benefit patients with pain that’s hard to manage using traditional forms of treatment, such as radiation therapy.

Although a conventional course of radiation therapy delivered over a series of days to weeks is considered standard care for persistent pain, it has its drawbacks. Statistics show that approximately 60% of patients obtain partial pain relief and only 32% of patients respond with complete palliation.7 Additionally, pain relief following radiation therapy isn’t immediate and can take several weeks.2 Moreover, radiation treatment does have dosage limits. Once dose thresholds of the adjacent normal tissue, such as the spinal cord in the case of spinal metastatic lesions, have been met, recurrent pain at a previously treated site often can’t be retreated.2

A previous feasibility study suggested that combining radiation and ablation therapies may work together to achieve better outcomes compared to using each as a standalone treatment.8  The effect of combined treatments on metastatic spinal tumors was recently reported by Greenwood et al. who carried out a retrospective study, which analyzed medical records of 21 patients with 36 metastatic spine lesions—including radioresistant tumors—treated with the combination of radiation therapy and targeted radiofrequency ablation using the STAR Tumor Ablation System between March 2012 and June 2014.2

Post-procedure outcomes showed patient reported pain measured with the numerical rating scale (NRS) to decrease significantly from an average 8 out of 10 pre-treatment to 4.3 at 1-week and 2.9 at 4-weeks post-treatment. Opioid pain medication use also reduced in 62% of the patients and general activity level increased in 81% of patients at a 4-week follow-up. Post-procedural imaging showed stable treated disease in 12 of 13 and 10 of 10 patients at 3- and 6-months, respectively.

Based on these findings, the authors considered it effective to use ablation and radiation therapies together to treat pain in patients with metastatic spinal lesions and could be an option for those with radiation resistant tumors.

From its start in 1992 treating a handful of patients with benign bone tumors, radiofrequency ablation therapy transformed into an established method of treating metastatic bone disease.3

Almost two decades later in 2012, following FDA 510(k) clearance, DFINE Inc. introduced a percutaneous radiofrequency ablation device purpose built for the palliative treatment of spinal metastatic lesions. Acquired by Merit Medical earlier this year, DFINE Inc. and its unique line of medical devices—including the STAR Tumor Ablation System—are now a part of Merit’s growing portfolio of state-of-the-art oncology products.

It’s estimated that half or more of cancer patients may experience bone pain.1 Metastatic bone lesions are exceedingly common among these individuals and have been found to be the most prevalent cause of chronic pain in this population.3 These tumors have been seen in up to 80% of cancer patients at the time of death, with spinal metastases occurring in about 50% of these cases.3

The STAR Tumor Ablation System can be an option for these patients by offering rapid relief and improved quality of life.4 “If you look at a lot of the treatments that are used [to treat metastatic spine tumor pain], quality of life and life expectancy are not included. And they should be factored in,” explained Jack Jennings, PhD, MD, Diagnostic Radiologist, Associate Professor of Radiology at the Washington University School of Medicine, and Director of Musculoskeletal and Spine Interventions at Mallinckrodt Institute of Radiology in St. Louis, Mo. “Daily we physicians see these patients suffering with pain that has dramatically affected the life they have left.”9

 

REFERENCES

  1. Smith, H. (2011). Painful osseous metastases. Pain Physician, 14(4): E373-405. http://www.painphysicianjournal.com/linkout?issn=1533-3159&vol=14&page=E373
  2. Greenwood, T., Wallace, A., Friedman, M., Hillen, T., Robinson, C., & Jennings, J. (2015). Combined ablation and radiation therapy of spinal metastases: a novel multimodality treatment approach. Pain Physician, 18(6): 573-581. http://www.painphysicianjournal.com/current/pdf?article=MjQ1Mg%3D%3D&journal=92
  3. Anchala, P., Irving, W., Hillen, T., Friedman, M., Georgy, B., Coldwell, D., Tran, N., Vrionis, F., Brook, A., & Jennings, J. (2014). Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: a multicenter retrospective study. Pain Physician, 17(4): 317-327. http://www.painphysicianjournal.com/current/pdf?article=MjEyOA%3D%3D&journal=83
  4. Bagla, S., Sayed, D., Smirniotopoulos, J., Brower, J., Neal Rutledge, J., Dick, B., Carlisle, J., Lekht, I., & Georgy, B. (2016). Multicenter prospective clinical series evaluating radiofrequency ablation in the treatment of painful spine metastases. CardioVascular and Interventional Radiology, 39(9): 1289-1297. doi: 10.1007/s00270-016-1400-8. https://www.ncbi.nlm.nih.gov/pubmed/27343124
  5. National Comprehensive Cancer Network. (2016). NCCN Guidelines. Retrieved October 18, 2016 from https://www.nccn.org/professionals/physician_gls/f_guidelines.asp
  6. Merit Medical Systems Inc. (2014). Press Release: Multi-Center Trial Shows Significant Pain Relief For Spine Cancer Patients Following Targeted Radiofrequency Ablation Treatment. Retrieved October 20, 2016 from, https://www.merit.com/category/press-release/
  7. Sze, W., Shelley, M., Held, I., & Mason, M. (2004). Pallation of metastatic bone pain: single fraction versus multifraction radiotherapy – a systematic review of the randomised trials. The Cochrane Database of Systematic Reviews. (2): CD004721. https://www.ncbi.nlm.nih.gov/pubmed/15106258
  8. Di Staso, M., Zugaro, L., Gravina, G. L., Bonfili, P., Marampon, F., Di Nicola, L., Conchiglia, A., Ventura, L., Franzese, P., Gallucci, M., Masciocchi, C., Tombolini. V. (2011). A feasibility study of percutaneous radiofrequency ablation followed by radiotherapy in the management of painful osteolytic bone metastases. European Radiology, 21(9): 2004-2010. doi: 10.1007/s00330-011-2133-3. https://www.ncbi.nlm.nih.gov/pubmed/21533865
  9. Merit Medical Systems Inc. (2016). STAR™ Tumor Ablation System. Retrieved October 17, 2016, from https://www.merit.com/interventional-oncology-spine/spine-ablation/ablation/star-tumor-ablation-system/

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

Achieve Radial Access with Ease

By Alicia Armeli

PreludeEase™—Merit Medical’s newest line of Hydrophilic Sheath Introducers—has made the transradial artery approach even better. Studies show that hydrophilic coating on sheath introducers can reduce the incidence of artery spasm and improve patient comfort during transradial diagnostic and interventional coronary procedures.1

In recent years, the transradial approach has become increasingly popular for diagnostic and interventional coronary procedures. In comparison to transfemoral access, the transradial approach is linked to fewer vascular complications, shorter hospital stays, and reduced mortality.2 Financially, using the transradial technique may reduce direct and indirect hospital costs, while minimizing the overall financial burden from a larger social perspective.3,4

Notwithstanding these benefits, vascular complications can arise. More specifically, radial artery spasm is a common complication during transradial procedures and can lead to severe patient discomfort and diminished procedural success.1,5

A team of researchers at the Liverpool Heart and Chest Hospital in Liverpool, UK, examined the impact hydrophilic-coated sheath introducers had on the rate of radial artery spasm.1 In all, 790 patients scheduled for a transradial coronary procedure were randomly assigned hydrophilic-coated or uncoated sheath introducers. Results published in the Journal of the American College of Cardiology showed that radial artery spasm was seen significantly less in patients using a hydrophilic-coated sheath introducer (19.0% vs. 39.9%). Within the hydrophilic-coated group, less discomfort was also reported (15.1% vs. 28.5%). Sheath length didn’t influence these outcomes.

These results only mirror findings of numerous other studies. Saito et al. found sheath introducers with hydrophilic coating to lessen friction resistance by 70% in an in vitro model, which helped with sheath removal.6

A study published in Catheterization and Cardiovascular Interventions further investigated whether hydrophilic coating reduced the required force of sheath removal and any associated patient discomfort.5 Through a randomized double-blind comparison, Kiemeneij et al. analyzed 90 patients undergoing transradial percutaneous coronary intervention. Each patient received a sheath of identical length and diameter—the only difference being the presence or absence of hydrophilic coating.

Findings showed 3 patients (7%) in the coated group reported discomfort versus 12 patients (27%) in the uncoated group. Required force, measured in maximum and mean pullback force, was also significantly lower in the coated group.5

In addition to hydrophilic coating that extends to the sheath tip, the kink-resistant PreludeEASE tubing helps to provide procedural reliability. Smooth transitions between wire to dilator and dilator to sheath were designed for ease of insertion and can help enhance patient comfort. Available in 4F through 7F diameters and multiple lengths, PreludeEASE anticipates various clinical needs and diverse patient anatomy without compromising its slim profile and large inner diameter.

PreludeEASE sheaths are available in a variety of kit configurations, including one and two-part access needles, several guide wire options, a BowTie™ Guide Wire Insertion Device, and more. In addition, Merit can customize PreludeEASE radial access kits to meet both specific and a wide variety of clinical needs.

PreludeEASE Hydrophilic Sheath Introducers complement Merit’s growing line of products designed to support radial access procedures from preparation to hemostasis. In this way, PreludeEASE can help interventional cardiologists not only perform radial access procedures with success—but with ease.

Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

REFERENCES

  1. Rathore, S., Stables, R., Pauriah, M., Hakeem, A., Mills, J., & Palmer, N. et al. (2010). Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention. JACC: Cardiovascular Interventions, 3(5): 475-483. https://www.ncbi.nlm.nih.gov/pubmed/20488402
  2. Schussler, J., Vasudevan, A., von Bose, L., Won, J., & McCullough, P. (2016). Comparative efficacy of transradial Versus transfemoral approach for coronary angiography and percutaneous coronary intervention. The American Journal Of Cardiology, 118(4): 482-488. http://dx.doi.org/10.1016/j.amjcard.2016.05.038
  3. Amin, A., House, J., Safley, D., Chhatriwalla, A., Giersiefen, H., & Bremer, A., et al. (2013). Costs of transradial percutaneous coronary intervention. JACC: Cardiovascular Interventions, 6(8): 827-834. doi: 10.1016/j.jcin.2013.04.014. https://www.ncbi.nlm.nih.gov/pubmed/23871512
  4. Kołtowski, Ł., Filipiak, K., Kochman, J., Pietrasik, A., Huczek, Z., & Balsam, P. et al. (2016). Cost-effectiveness of radial vs. femoral approach in primary percutaneous coronary intervention in STEMI – Randomized, control trial. Hellenic Journal Of Cardiology, 57(3): 198-202. http://dx.doi.org/10.1016/j.hjc.2016.06.005
  5. Kiemeneij, F., Fraser, D., Slagboom, T., Laarman, G., & van der Wieken, R. (2003). Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: A randomized double-blind comparison of coated and uncoated sheaths. Catheterization And Cardiovascular Interventions, 59(2): 161-164. http://dx.doi.org/10.1002/ccd.10444
  6. Saito, S., Tanaka, S., Hiroe, Y., Miyashita, Y., Takahashi, S., & Satake, S. et al. (2002). Usefulness of hydrophilic coating on artery sheath introducer in transradial coronary intervention. Catheterization And Cardiovascular Interventions, 56(3): 328-332. http://dx.doi.org/10.1002/ccd.10202

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

What Is the Super HeRO?

superhero

By Alicia Armeli

Short of leaping tall buildings at a single bound, the Super HeRO™ Adapter is living up to its name.

“The Super HeRO gives you options to customize your approach—unique patients unique procedures.” –Dr. Stephen E. Hohmann, MD, FACS, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, Texas

“The new HeRO Graft Adaptor gives vascular access surgeons a variety of options on which graft to use instead of the standard PTFE. I currently use the ACUSEAL graft, which can be cannulated in 24 hours and there is no need for a bridge catheter. Removing the permcath at the same time as the insertion of the HeRO Graft decreases the risk of infection for these dialysis patients with central vein pathology and no need to come back for an additional procedure to remove the catheter.” –Dr. Jesse Garcia, MD, MedStar Washington Hospital Center, Washington, DC

“The Hero Adapter has opened a new window of opportunity in the creation and rescue of complex hemodialysis access.”—Dr. David Varnagy, MD, FACS, Vascular Institute of Central Florida, Orlando, Fla.

These are only a few of the positive comments made by vascular surgeons regarding the newest addition to the growing family of Merit Medical dialysis devices. The Super HeRO Adapter and its accompanying HeRO Ally™ Revision Kit are a one-of-a-kind dynamic duo of dialysis technology that offer surgeons the same safety and efficiency of the original HeRO™ (Hemodialysis Reliable Outflow) Graft—but with the added flexibility of more graft options to choose from.

Proper vascular access is essential for dialysis adequacy. And yet vascular access complications are the leading cause of morbidity among dialysis patients and add to high healthcare costs.1 It’s these same complications that lead to hospitalization of dialysis patients between one and two times every year.2

Central venous stenosis is a common and serious vascular complication that involves the narrowing of the veins leading to the heart. These central veins are often the final common route used for dialysis, and once occluded, vascular access is eventually lost and life expectancy diminishes.3

This is a serious health risk for patients requiring dialysis, especially those who are catheter-dependent. Central venous stenosis is linked to external catheterization, as studies have shown that approximately one out of four patients with venous stenosis has a history of central venous catheter placement.4

Catheters are used in approximately 80% of patients starting dialysis and 25% of all prevalent patients as a bridge to permanent vascular access or because all options for permanent access have been exhausted.5  Patients using a catheter are not only at risk for venous stenosis but are four times more susceptible to access-related infection than patients with a graft and eight times more at risk than those who have a fistula.6

To bypass venous stenosis and improve long-term dialysis, various permanent subcutaneous arteriovenous graft devices have been manufactured as a solution for dialysis patients who have exhausted all other access options.

One such product called the HeRO Graft was approved by the FDA in 2008. In comparison to catheters, it’s the only clinically proven permanent subcutaneous arteriovenous graft to reduce the risk of vascular access-related infections by 69%, improve adequacy of dialysis by up to 32% (1.7 Kt/V), and cut interventions needed to maintain access function by more than half.7 Studies have also linked the HeRO Graft to high cumulative patency rates that reach 87% at two years.8

But unlike other graft products, the HeRO Graft doesn’t depend on venous anastomosis to bypass venous stenosis. Instead, a radiopaque silicone Venous Outflow component reinforced with kink and crush-resistant nitinol braid is placed in the right atrium and securely attaches to an adjacent ePTFE hemodialysis graft by way of a proprietary titanium connector. This mechanism allows for blood to return from the veins back to the heart.

Now, eight years after the launch of the HeRO Graft, the Super HeRO Adapter emerges as an additional way to help access-challenged patients with central venous stenosis.

superheroadapterseal_sm

Graft compatibility is what makes the Super HeRO Adapter a one-of-a-kind product and a superior alternative to catheters. By having the same safety, dialysis adequacy, and patency advantages of the standard HeRO Graft but with a wider range of compatible graft products to choose from, using the Super HeRO could mean the difference between contracting and avoiding infection.

Researchers at the University of Miami Hospital in Miami, Fla., demonstrated the validity of this premise by examining the safety and efficacy of the standard HeRO Graft in comparison to tunneled dialysis catheters. Thirty-six access-challenged patients with venous stenosis were implanted with the HeRO Graft and followed over a course of almost 9 months.7

Results published in the Journal of Vascular Surgery showed that access-related bacteremia rates were significantly lower among patients using the HeRO Graft (0.7 events per 1000 days), but that infection only occurred during the bridging period when a catheter was implanted prior to the HeRO graft being used.7

Circumventing the 2-4 week bridging period and avoiding the risk of infection is one of the major advantages of the Super HeRO Adapter, especially since infection is a frequent cause of hospitalization and the second most common cause of death among dialysis patients.9 By connecting the Venous Outflow component to an early cannulation graft, a patient can be implanted today and dialyzed the next, virtually eliminating the risk of access-related infection due to a bridging catheter.

Early cannulation grafts compatible with the Super HeRO Adapter include GORE® ACUSEAL grafts and FLIXENE® Standard Wall grafts. If an early cannulation graft isn’t used, the Super HeRO Adapter also works with single-wall options, including GORE-TEX® and IMPRA®.

Cost savings advantages seen with the standard HeRO Graft can also be applied to the Super HeRO Adapter. A US healthcare model for provision of dialysis access predicted that in comparison to catheters, using the HeRO Graft could result in an average of 23% annual savings.10 Dialysis centers could save over $3000 per patient each year.11 And hospitals can save thousands in hefty admission costs that accrue because of device-related infections—rates that would commonly range between $23K to $56K per stay.12,13

These cost savings are being recognized around the globe. At the University Hospital at Birmingham, a British economic study analyzed the cost of introducing the HeRO Graft in the UK.14 Shakarchi et al. compared the cost of the HeRO Graft versus tunneled dialysis catheters by carrying out a 1-year cost-consequence decision analytic model that measured vascular access function, infection, device thrombosis, and associated costs over four 3-month intervals.

Based on a 100-patient cohort managed with the HeRO Graft, results of the study revealed 6 fewer failed devices, 53 fewer access-related infections, and 67 fewer device thromboses compared to patients managed with catheters.14  The authors concluded that even though the initial device and placement costs for the HeRO Graft are more expensive than catheters, the savings that occur because of fewer device complications and longer effective device patency minimizes these costs. Overall, a net 1-year savings of £1200 per patient was estimated for patients managed with the HeRO Graft.

Another cost-effective option offered by the Merit team is the HeRO Ally Revision Kit—a viable solution for long-term dialysis patients who still have a functioning Venous Outflow component—but need a new graft. The Revision Kit contains the tools needed to place a new Super HeRO compatible graft, which includes the Adapter, Support Seal, Graft Expander, Vascular Clamp, and Syringe for Heparinized Saline. Sold separately from the Super HeRO itself and compatible grafts, the HeRO Ally gives clinicians the freedom to purchase their compatible graft of choice.

By using these tools—whether it’s the Super HeRO, HeRO Ally Revision Kit, or the standard HeRO Graft—clinicians are offering access-challenged patients who’ve exhausted all other options a longer life expectancy and—above all—hope.

“It’s exciting to know that there’s something out there,” said Kay, referring to the HeRO Graft.15 After experiencing failure with traditional access grafts and catheters, Kay was faced with no other options—until her doctor suggested the HeRO Graft. “I’m not so depressed now,” Kay told Merit Medical. “I’m on the go more. I go places more and do things more.”

The HeRO products can also give loved ones peace of mind. “We have less to worry about,” explained Katie, Kay’s daughter and caregiver.14 “We’re not worried about infection. We’re not worried about clotting. The dialysis is just more efficient. She feels better.”

Merit Medical’s HeRO technology not only saves the lives of countless dialysis patients, but also enhances them. “I consider it my lifeline,” Kay said. “It keeps me alive.” And if that’s not the true mark of a superhero, I don’t know what is.

 

REFERENCES

  1. Hemachandar, D. (2015). Analysis of vascular access in haemodialysis patients—single center experience. Journal of Clinical and Diagnostic Research, 9(10): OC01-4. doi: 10.7860/JCDR/2015/13342.6611. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625272/
  2. Adib-hajbagheri, M., Molavizadeh, N., Alavi, N. S., & Abadi, M. H. M. (2014). Factors associated with complications of vascular access site in hemodialysis patients in Isfahan Aliasghar hospital. Iranian Journal of Nursing and Midwifery Research, 19(2): 208-214. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4020033/
  3. Beathard, G. A. (2016). Central vein stenosis associated with hemodialysis access. Retrieved October 5, 2016, from http://www.uptodate.com/contents/central-vein-stenosis-associated-with-hemodialysis-access
  4. Kundu, S. (2009). Central venous obstruction management. Seminars in Interventional Radiology, 26(2): 115-121. doi: 10.1055/s-0029-1222454. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3036427/
  5. Al-Solaiman, Y., Estrada, E., & Allon, M. (2011). The spectrum of infection sin catheter-dependent hemdialysis patients. Clinical Journal of the American Society of Nephrology, 6(9): 2247-2252. doi:  10.2215/CJN.03900411. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3359000/
  6. National Kidney Foundation. (2012). A Clinical Update on an Alternative Vascular Access for the Catheter-Dependent Hemodialysis Patient. Retrieved October 6, 2016, from https://www.kidney.org/sites/default/files/12-10-4487_KBB_ClinicalUpdateOnAlternateiveVA.pdf
  7. Katzman, H., McLafferty, R., Ross, J., Glickman, M., Peden, E., & Lawson, J. (2009). Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. Journal Of Vascular Surgery, 50(3): 600-607.e1. doi: 10.1016/j.jvs.2009.04.014. http://dx.doi.org/10.1016/j.jvs.2009.04.014
  8. Gage, S., Katzman, H., Ross, J., Hohmann, S., Sharpe, C., Butterly, D., & Lawson, J. (2012). Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] Graft implants for hemodialysis treatment. European Journal Of Vascular And Endovascular Surgery, 44(1): 93-99. doi: 10.1016/j.ejvs.2012.04.011. http://dx.doi.org/10.1016/j.ejvs.2012.04.011
  9. Laurin, L., Harrak, H., Elftouh, N., Ouimet, D., Vallee, M., Lafrance, J. (2015). Outcomes of infection-related hospitalization according to dialysis modality. Clinical Journal of the American Society of Nephrology, 10(5): 817-824. doi: 10.2215/ CJN.09210914. http://cjasn.asnjournals.org/content/10/5/817.full
  10. Dageforde, L., Bream, P., & Moore, D. (2012). Hemodialysis Reliable Outflow (HeRO) device in end-stage dialysis access: a decision analysis model. Journal Of Surgical Research, 177(1): 165-171. doi: 10.1016/j.jss.2012.04.041. http://dx.doi.org/10.1016/j.jss.2012.04.041
  11. Yost, L., Dinwiddie, L. (2010, Nov.). Impact of the use of the HeRO vascular access graft vs. tunneled dialysis catheters on dialysis provider economics in an era of bundling. Poster session presented at ASN, American Society of Nephrology, Denver, CO.
  12. Ramanathan, V., Chiu, E., Thomas, J., Khan, A., Dolson, G., & Darouiche, R. (2007). Healthcare costs associated with hemodialysis catheter–related infections: a single‐center experience. Infection Control And Hospital Epidemiology, 28(5): 606-609. doi: http://dx.doi.org/10.1086/513617
  13. O’Grady, N., Dellinger, E., Gerberding, J., Heartd, S. Maki, D., Masur, H., McCormick, R., Mermel, L., Pearson, M., Raad, I., Randolph, A., & Weinstein, R. (2002). Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics, 110(5): e51.
  14. Al Shakarchi, J., Inston, N., Jones, R., Maclaine, G., & Hollinworth, D. (2016). Cost analysis of the Hemodialysis Reliable Outflow (HeRO) Graft compared to the tunneled dialysis catheter. Journal Of Vascular Surgery, 63(4): 1026-1033. doi: 10.1016/j.jvs.2015.10.089. http://dx.doi.org/10.1016/j.jvs.2015.10.089
  15. Merit Medical Systems, Inc. (2016, Aug 26). HeRO® Graft – Kay and Katie: A Patient’s Story of Receiving a HeRO Graft. [Video File]. Retrieved from https://youtu.be/OztHLxZ2CG8

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

Physician Faculty to Impart their Commitment to Interventional Spine Procedures during Upcoming Education Program

Amish Doshi, MD Course Director

Amish Doshi, MD
Course Director

As an interventional neuroradiologist, Dr. Amish Doshi, Associate Professor of Radiology and Neurosurgery, Chief of Neuroradiology and the Director of Spine Imaging and Interventions at the Mount Sinai Hospital in New York City, has had the opportunity to treat a variety of disorders of the head, neck and spine.  Throughout his career, he has developed a special interest in the diagnosis and treatment of spine disorders through both imaging interpretation and spinal interventional procedures.

After years of observing benefits for his patients, he chooses to focus on vertebral augmentation and radiofrequency ablation to treat spinal fractures and spinal tumors. With improvements in cement viscosity, navigational instrumentation and use of radiofrequency technology, especially in the field of spinal tumor treatment, Dr. Doshi has increased his focus on the treatment of local tumor control and pain palliation in the setting of metastatic disease to the spine.

Dr. Doshi will imbue his knowledge of and experience in targeted vertebral procedures later this week at the Interventional spine training course hosted by Merit Medical at Mount Sinai. During the course, physicians will gain hands-on cadaver experience with the minimally invasive procedures of vertebral augmentation, vertebroplasty and spine tumor ablation, using Merit’s StabiliT® Vertebral Augmentation Systems and the STAR™ Tumor Ablation System.

Other program faculty members include Dr. Reade De Leacy, Director of Neurointerventional Spine for Mount Sinai Hospital: Dr. Ramsey. Abadir, Chairman of Radiology and Director of Interventional Radiology, Orange Regional Medical Center in Middletown, NY; Dr. Michael Hallisey, Chief, Vascular & Interventional Radiology, Hartford Hospital, Hartford, CT; Dr. Avi Beck, Quantum Imaging and Therapeutic Associates, Lewisberry, PA; and Jennifer Merhar, R.N., Jefferson Radiology, Outpatient IR Center, Hartford, CT.

Merit Medical plans to announce its 2017 schedule for Interventional spine training courses in the coming weeks. To learn more, visit Merit.com/PEC.

Merit Medical Launches Think Hero Graft Training Program

Merit Medical’s inaugural Think HeRO Graft Training Course was held at the Methodist Institute for Technology, Innovation & Education (MITIE) in Houston, TX on September 22 and 23.

ThinkHeroGraft is an education program that prepares surgeons and physicians to use the HeRO® Graft as a method for end-stage dialysis access, for patients with central venous stenosis who would otherwise be catheter-dependent.

Proctor Dr. Eric Peden, Chief of Vascular Surgery at the Houston Methodist DeBakey Heart & Vascular Center, led engaging discussions and hands-on training with a cadaver lab, which allowed attendees to practice actual implantation procedure steps.

Dr. Peden, who has over 10 years of experience working with HeRO Graft and was one of its principal investigators, shared his best practices in patient selection, implantation techniques and maintenance strategies.

Attendees learned the clinical science and healthcare economics of the Hero Graft, identification of patient candidates and contraindications, as well challenges and complications.

Please contact your Merit Representative for future Think Hero Graft training opportunities.

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Merit Medical Hosts Physician Education Course at Washington University in St. Louis

September 17th, 2017

Merit Medical hosted 12 physicians for a Physician Education Course on minimally invasive vertebral therapies on Saturday, September 17th, 2017 at Washington University in St. Louis.  The Physician Education Course program is a focused cadaver lab workshop designed to deliver detailed information on appropriate use of Merit’s technology and the minimally invasive procedures of vertebral augmentation, vertebroplasty and spine tumor ablation, using Merit’s StabiliT® Vertebral Augmentation Systems and the STAR™ Tumor Ablation System. Expert faculty is chosen to present the supporting clinical data and share their tips and tricks.

To learn more or sign up for a future course visit https://www.merit.com/pec/

The DriPAD™: Super Absorbent Technology that Helps to Provide Better Patient Care

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From assisting a patient with incontinence care, to assisting in reducing room-turn over time, the DriPAD has numerous applications and can be used in multiple areas within a hospital. Having up to 10x more absorption power than alternative pads, using a product with a higher absorbency means fewer pads used per patient—which supports hospital cost-cutting initiatives and reduces biohazard waste disposal costs.

Through super absorbent technology, the DriPAD soaks up to 35x its weight in fluids. Each DriPAD features a robust polypropylene backing to provide a barrier that prevents leakage with a specially treated absorbent core that wicks moisture away from the skin for ultimate protection. This can help provide better patient care both during procedures and in the post-surgical-care environment.

The DriPAD not only keeps patients dry, but it also helps control odors through an EPA registered Silver Ion agent. Many hospitals are looking for ways to continuously deliver positive outcomes while being environmentally friendly. Furthermore, just one DriPAD replaces many underpads, reducing the amount of unnecessary trash in landfills.

Available in various sizes and absorption capacities, the DriPAD extends its care beyond the hospital, making it easy to use at home.

I Am Merit: Matt Wiker, Director of Global Materials

As Merit Medical’s global footprint continues to grow, Matt Wiker, Merit Medical Director of Global Materials, speaks about his role to ensure that Merit’s customers, and ultimately patients and hospitals, receive high quality products when and where they need them.

I Am Merit: Allen Guo

AllenGuo

My Opportunities in China with Merit:

I started working at Merit 6 years ago as an Operations Supervisor. Before that, I worked at GE Healthcare under the medical system machines division in Beijing. I was promoted to Operations Manager after 1.5 years and was further promoted to my current position of Senior Operations Manager after another 2 years. My operations coverage has also been extended from Mainland China to the rest of the Hong Kong, Taiwan, Southeast Asia areas and Korea. The reason why I stayed at Merit is really simple and straight-forwarded: great people and plenty of opportunities.

Merit in Mainland China:

In 2010, I was one of 3 people working for Merit in a small 700-square-meter warehouse (7534 square feet). Now, I have a team of 10 people with 8 employees working at our newly-established 1800-square-meter (20,000 square feet) warehouse and distribution center handling distribution in Mainland China. One team member looks after the forecast and planning in Mainland China and the final team member is located in Hong Kong and provides operation supports to the region. Over the past 5-6 years Merit has dramatically expanded with a steady double-digit growth rate. We have increased the numbers of sales licenses to over 50. These licenses are issued by the Chinese government to sell medical devices within China. One of the major growth factors can be attributed to Merit’s strong sales team, who work with 400 different distributors in China’s key cities.

Facing the Challenge of Growth:

As a department head leading the Asia operation, I have built up a reliable, responsible and passionate operation team. I lead my team to overview the sales forecasts to establish a proper supply chain, while maintaining a high order fulfillment rate for the entire Asia region. Apart from managing Merit’s warehouse in Beijing, we also have a third party logistics warehouse in Hong Kong as the regional distribution center.

Merit’s Vision in China:

Being customer oriented is the main vision that I focus on. Operation is a supporting function that I have two groups to serve, my internal and external customers.  Sales and Marketing teams are my internal customers. Mutual understanding on their specific needs and special requests are the vital elements for me to provide necessary supports to them. Distributors and hospitals, who purchase our products are my external customers. My main focus is to lean the operation process in order to improve the order implementation efficiency; as well as improve the forecast accuracy and the order fulfillment rate.

Friends, Family and Football:

When I’m not analyzing supply/demand numbers, I like to play football with my friends, not American football but European football, “soccer”. I also like to go to gym after work. The majority of my leisure time is spent with my family. I’ve been married for 8 years to my wife Yuanyuan and have two daughters. One is 5-years-old, her name is Sherry and her little sister has just arrived last month on March 29. I call her little beauty at the moment, but still haven’t given her an English name. We are welcome to any suggestion!

New High Flow Pigtail Valved One-Step™ Centesis Catheters

OSV_OS_PigStaightFullgreen

We are excited to announce the release of the new high flow Pigtail Valved One-Step™ Centesis Catheter!

These catheters have been designed for safe, controlled insertion with decreased procedure times.

The distal obturator prevents the needle from puncturing and shearing the catheter, and protects the clinician from accidental needlestick. The self-sealing valve also minimizes the risk of air infiltration, and fluid leakage.

The sharp needle and smooth transitions ease insertion and decrease patient discomfort, while the depth markers and echo-enhanced needle help with fast and accurate placement.

Procedure times may be decreased due to the fast flow rates. When compared with a leading competitor, the high flow Valved One-Step Centesis Catheter has a 16% faster flow rate*. The fast flow rates are due to the pigtail protecting the large drainage holes from occlusion, kink-resistant material, and large catheter and hub inner diameters.

To incorporate the high flow Pigtail Valved One-Step Centesis Catheter into your practice, contact your Merit Medical sales professional today or visit merit.com to learn more.

*Tested with 5F X 10 cm straight catheters

Merit Medical is Looking Forward to SIR this Weekend

Liu-and-Klass

Merit Medical and ThinkRadial will host several exciting events at the Society of Interventional Radiology annual meeting in Vancouver, BC, Canada from April 3-6. A series of activities taking place in Merit’s booth, #419, will provide attendees with a chance to learn about Merit’s innovative offerings through both hands-on experience and interactive presentations from transradial intervention and embolotherapy experts.

The first of Merit’s live presentations will take place from 9:30 am to 10:30 am on April 5. In this session, Dr. David Liu, MD, FRCPC, FSIR, will discuss “The Development and Evolution of a Hepatocellular Carcinoma Embolotherapy Program: Rationale, Experience and Approach at Vancouver General Hospital”. From 12:00 pm to 1:00 pm on April 5, Dr. Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, will host “Transradial Approach – Beyond the Basics: A Discussion of Cases and Tips With Expert Interventional RadialistTM, Dr. Darren Klass.”

Booth visitors will also have several opportunities to interact with and learn more about Merit’s product line supporting transradial intervention, including the most comprehensive offering of transradial access tools for Interventional Radiology; patient set-up, access, angiography, intervention and hemostasis, and for the first time, the Performa® Transradial Peripheral Angiographic catheter in longer lengths for peripheral radial access. ThinkRadial’s one-of-a-kind radial vascular model will also be available for hands-on product demonstrations.

Merit will also showcase products dedicated to the latest in embolotherapy interventions, including Embosphere® Microspheres, QuadraSphere® Microspheres (cleared in US and now additionally indicated for hepatoma), and HepaSphereTM Microspheres (indicated for use with or without doxorubicin outside the US).

At SIR, Merit will also showcase the following products:

  • HeRO® Graft, recently acquired from Cryolife, Inc
  • CorVocet™ Biopsy System*
  • SwiftNINJA® Steerable Microcatheter**
  • PAK™ Pedal Access Kit***
  • Advocate™ PTA Catheters
  • SPINR™ High-Performance Guidewire Controller
  • One-Step™ Centesis Catheters with Pigtail
  • Performa® Transradial Peripheral Angiographic catheter in longer lengths

Additionally, Merit team members will be available to discuss their recent transition from a distributor model to a direct sales model for Canadian customers.

* Not available in EU or CAN.
** Available in EU. Not available in US or CAN.
*** Not available in CAN.

I Am Merit: Melissa Green

IMG_3584-2Nearly 20 Years at Merit! In 1992 I went to work for Mallinckrodt in Angleton, TX. I was in Production working on the Performa and Trax catheters (now Merit’s Concierge Catheter). In 1998, Merit Medical acquired a small division of Mallinckrodt and that’s when my career with Merit began. We operated in the Angleton facility until 2014, and now our entire operation has been moved to a brand new facility in Pearland, TX.

When Merit acquired Mallinckrodt I moved first into a shipping/receiving role and was then promoted to Planner nearly 15 years ago.

Analyzing Data is my Passion as a Planner. I really enjoy my role as Planner. I am responsible to make sure we can meet the demands of our customers by ensuring adequate inventory of our products. I review sales orders and forecasts and compare them against worldwide inventory, and then work with Production to ensure that they’ve scheduled enough product to meet upcoming orders. If inventory is running low I notify Production and Marketing so that more product is manufactured, and I keep our customers and sales staff informed through the Customer Service teams worldwide. I love analyzing the data, working with the numbers and putting all the pieces together like a puzzle.

My New Role with Merit Endotek. Last year, I moved into a dual Planning and Purchasing role for all Merit Endotek products. So in addition to my Planning responsibilities, I ensure the availability of all raw materials needed to manufacture the Endotek products. If raw material inventory is running low in relation to customer order forecasts, I work with our vendors to order additional raw materials.

New Faces Everywhere. Merit has been a good company for me to work for. I have a great support staff and enjoy my peers and managers. When Merit first bought Mallinckrodt we were a small team. Now I see new faces everywhere. It has been fun to watch the company grow and know that I’ve played a role in all of it.

When I’m not at Work. When I’m not at Merit, I enjoy spending time with my family back in Angleton. I have two children – a daughter who is 23 and attends college and a son in high school.

I Am Merit: Linda Sigvardt

Linda3The story behind Merit’s Travel Department

I’ve worked in the travel industry for over 30 years. It could have been my love of airplanes or the desire to experience exotic cultures in remote countries that drove me to work in the travel industry. I’ve always known my place would be in corporate travel sphere. My involvement with Merit started over 15 years ago, first as account manager with Travel Zone and as they were sold, I moved to Hess Travel and Merit followed. Then Fred approached me with a job offer to manage Merit’s travel internally. I’ve been at Merit for 2 ½ years now and have seen significant changes and major improvements with the value Merit receives with its travel arrangements.

The one-woman travel agency

When I started working for Merit, Fred gave me three main directives. The first directive was to establish a duty of care plan, which ensures the safety of all Merit employees while traveling. The duty of care is one of the most important areas of my work. We want to ensure that every Merit employee is accounted for in any situation. The second directive was to establish beneficial vendor relationships, which provide Merit with the lowest possible rates and best customer service. Merit has negotiated rates with several airlines, car companies, hotels and AAA to improve Merit’s savings globally. Sometimes it just comes down to waivers and favors and Merit’s travel department have the privileges and benefits available. The third directive was to organize and establish travel policies for Merit employees. The guidelines we’ve established in the travel department are focused on providing Merit employees with the most seamless travel experience possible. These guidelines also ensure Merit with the lowest possible travel costs and provide the traveler with our duty of care.

My time to travel

I really do love to travel and have been to 11 countries and 30 states.  In 2014, I had the opportunity to travel to the Merit facilities in the U.S. and Europe to do field research. They were fast and furious trips, but they proved to be very valuable tools for me in assisting our travelers. Nothing can replace the “boot on the ground” experience for gathering information on airports and hotels near our facilities. When I’m not working, I spend a lot time with my daughter Chandler. If I have to pick our favorite things to do together, I would have to say hiking and shopping. We love to be in the mountains and in nature on a good trail. But we also love to shop just as hard as we hike.

I Am Merit: Esko Holt

Esko-Holt

First things first – Your Name is so Unique! Esko is a family name, it was my grandpa’s name. My grandfather was one of 13 kids. He grew up here in Richmond, Virginia next to a Russian family, and one of their children was named Esko. That’s where my great grandfather got the name for my grandfather and why my parents named me Esko.

Your Role at Merit: I have worked for Merit for 10 years. I landed here because I worked for a company called Medsource Packaging for two years and we were acquired by Merit. I took some time off and returned to Merit six months after the acquisition. I came back as a purchasing and planning agent. Ten years later I now manage the Purchasing and Planning departments.

I am responsible for scheduling all the production and for purchasing the raw materials for Richmond facility.

What happens at Merit’s Richmond Facility? Merit’s Richmond facility is responsible for custom kits, sterile medical procedure trays that carry all the tools a clinician needs to perform a specific procedure. Merit has the unique ability to customize our kits to meet our customers’ needs .

How have you seen the Merit Richmond Facility grow since you started? From the time Merit acquired Medsource through last year, sales at the Richmond facility have grown significantly. This demonstrates that the need for custom kits for physicians is obviously growing. We look at custom kits as a service provided for our customers and not just another product. It’s a service that makes their job easier by saving time and money for the clinicians.

What do you like about Merit: I really like the people at Merit, we are a family group. Everyone works well together. A lot of the employees from Medsource are still here with me for the last ten years. I really enjoy working directly with the Merit sales representatives to look for solutions for their customers.

After Work: When I’m not with my Merit family, I love to run. I’ve run several half-marathons. I’m also married with three kids: my youngest is a daughter, age 11; my middle is my son age 13; and my oldest is another daughter age 19.

Article: Transradial access for IR’s is gaining traction –An interview with three Interventional Radiologists

InterventionalNews

In its November issue, Interventional News reports that transradial access for Interventional Radiologists is gaining traction, as evidenced by the full room of attendees at a satellite symposium about the radial approach, sponsored by Merit Medical during the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting in September. In the article, Interventional News interviews the three symposium speakers, all interventional radiologists who are experts in the radial approach: Dr. Christoph Binkert, a professor of Radiology in Zurich, Switzerland; Dr. Aaron Fischman, an Interventional Radiologist and assistant professor of Radiology and Surgery, Mount Sinai Medical Center, New York, USA; and Dr. Darren Klass, Interventional Radiologist, Vancouver Coastal Health, Vancouver, Canada.

The three physicians outline the benefits to patients of radial artery access over transfemoral access and potential complications and data that shows a very low complication rate. They also comment on the need for radial-specific devices. In his commentary Dr. Klass discusses reasons why many interventional radiologists are hesitant to change to the radial approach and some of the reasons why these hesitations should be overcome. Finally, the article includes the top tips for starting a radial service, as provided by Dr. Klass.

Read the full Interventional News article.

Medical Design and Outsourcing features Merit Medical President and CEO Fred Lampropoulos in a Spotlight on Leadership

SJ Campus Nov 2015 Wide

In its January issue, Medical Design and Outsourcing features a Spotlight on Leadership by Merit Medical President and CEO Fred Lampropoulos, who describes Merit’s history of and continuous pursuit of innovation. View the full article: http://www.medicaldesignandoutsourcing.com/spotlight-on-leadership-merit-medical-continues-its-history-of-innovation/

I Am Merit: Jason Hansen

Jason Hansen

Like a true engineer, Jason drafted a diagram of his work.

Merit has been a great place to start my career. I graduated from the University of Utah in Biomedical Engineering in 2010. My education was the catalyst for my work in the medical industry. I studied advanced mathematics and physics, but my major also focused on engineering principles related to biology, chemistry, biomechanics, biomaterials, etc. It provided me with a solid foundation and Merit hired me out of college as an Engineering Tech. I worked hard in this position and was promoted to Manufacturing Engineer followed by the promotion to my current position, Engineering Project Manager for the last 3 1/2 years.

Engineering Project Manager. I have the responsibility to lead multidisciplinary teams to achieve specific project objectives. This involves initiating, planning, executing, monitoring, controlling, and closing projects. Over the past few years, I’ve been responsible for managing multiple product acquisitions and integrating the products into Merit. I am also responsible for product transfers, new product development, product improvements, product design and material changes.

My part in Merit’s vision. Merit’s vision of being the most customer-focused company in healthcare, has a clear influence on my work. A great example of this would be after the acquisition of the Centros hemodialysis catheter. Merit received multiple requests to include a stiffening stylet to facilitate over-the-wire procedures. My team and I worked with the customers to determine the specific needs, developed prototypes, received feedback, made improvements and repeated this process. The end result was the stiffening stylet currently sold today. My work at Merit is always influenced and focused on fulfilling the needs of the customer.

How my work makes a difference. When I was younger, my grandpa had end stage renal disease and was required to undergo dialysis treatment. I was very close to grandpa and when the doctors only gave him a few years to live, it was really hard for me personally. However, due to the innovative medical devices (like Merit’s Centros) and outstanding treatment, he lived for seven more years. Knowing the work I do at Merit every day improves the lives of others drives me to develop and manufacture the most innovative and highest quality products on the market.

Living life to the fullest. When I’m not working, I spend all of my time with my family in the outdoors enjoying life. My wife Ashlee and I have two kids, Milo 4-year-old boy, Kaylee 2-year-old girl, and #3 (boy) is due in March. We spend a lot of time in the outdoors; camping, fishing, riding 4 wheelers, and boating. Just last summer, we spent 32 nights under the stars camping as a family. My kids love the outdoors and could play in the dirt all day.

I Am Merit: Stephanie Poulsen

Senior Product Manager Stephanie Poulsen speaks about her role guiding strategies for the development of products used for diagnostic and interventional procedures. And more recently, her focus on products specific to the radial approach, a technique that has grown significantly around the world because it allows patients to get up and return to their lives faster. In her I am Merit video interview, Steph shares why she believes that her work at Merit is truly important and how it has touched her life personally.

I Am Merit: Casey Holland

Casey Holland reviewing clinical research with her staff.

Casey Holland reviewing clinical research with her staff.

Casey Holland, Clinical Operations Manager for Merit Medical, Rockland, Massachusetts, USA.

Perspective. I started working with BioSphere in 2007 in Quality and Regulatory Affairs, which worked closely with Medical Affairs. I worked hard during this period of time. I was really starting to focus and gain perspective on my career, which lead me to make the transition into Clinical Research in 2009. Then Merit acquired BioSphere in 2010 and I became a Merit employee. In 2012, I obtained my Masters degree from Northeastern University in Regulatory Affairs for Drugs, Biologics and Medical Devices. My Masters degree gave me detailed knowledge of all regulations pertaining to the development and commercialization of medical device products. Currently, I oversee all operations for three FDA approved clinical trials using Merit Medical products.

Most Rewarding. I feel that every part of my work is rewarding. Being the Clinical Operations Manager comes with great responsibility and importance. I manage a staff of ten highly specialized individuals here at the Merit office in Rockland, Massachusetts. We run three clinical trials involving hundreds of patients. The importance of clinical trials can’t be understated. All of my efforts are directed towards helping people. The development of innovative new treatments and products are important to the ever changing Healthcare Industry. Clinical trials are a crucial part of the innovation and development. I’m not a doctor. I’m not a nurse. But I am making a difference in the lives of patients through medical research. Having found my way of helping people, is what’s truly rewarding.

My Part in Our Vision. Merit Medical has the vision to “make a difference by understanding our customers needs.” Being the Clinical Operations Manager my work is directed towards understanding and documenting the needs of the patient. Just because a treatment is being used today, doesn’t mean that the treatment should be used tomorrow. Understanding the needs of the customer requires research and the development of new treatments. Clinical research gives us the ability to understand these needs and bring new products to the market.

New York Yankees? Absolutely not. No way. Not ever. I’m from Boston, our sports teams are a way of life here. Being from Boston, it’s not even a question of being a fan of our teams. We just are. We are Boston Strong. I just went to a Patriots game last weekend. It’s hard to explain, it’s just a real big thing and not just for the Red Sox, it’s for all our sports teams.

I Am Merit: Brandon Beck

Brandon presenting a manufacturing flow chart for an NPI project.

Brandon Beck, Senior Engineer for Merit Malvern, Pennsylvania, USA

My story here began 20 years ago: I started working here in the now “Merit Malvern” office twenty years ago, right after graduating from Penn State University. When I started it was Thomas Medical and I was a supervisor who worked on the team that built the Classic Sheath, a device for implanting leads for pacemakers and defibrillators. Years later we were acquired by GE Healthcare and then in December 2012, by Merit Medical. Now I’m a Senior Manufacturing Engineer, which means I look after our manufacturing processes to ensure efficiencies and quality, including ECN’s and validations. I review work that others produce and mentor other engineers so they can grow in their professions.

Thomas, then GE, then Merit: The transitions from company to company has been a positive experience. There’s a group of us who have been together for 15-20 years and have gone through these transitions together, making it all feel familiar. However, looking back over the past 20 years, I have been presented with so many varying opportunities and challenges. My goals from day-to-day and year-to-year are never the same. This has made working here feel new, exciting and challenging all the time.

What do you enjoy most about being a Manufacturing Engineer: I love solving problems all day long. Sometimes I feel like a CSI investigator. I love to fix and improve things so I spent many months training to receive my Lean Manufacturing and Six Sigma Black Belt certifications. Several years ago, we found that we were carrying six months of inventory for one of our most popular products. Utilizing lean and six sigma techniques and working with a team to determine how to reduce waste – we reduced the number of people working on that line by half and now only carry a two week inventory. These efficiencies benefit Merit and our customers.

Tell us about a project you feel most proud of: I’m proud of many of the projects I’ve worked on but the first one that comes to mind is the Steerable Sheath. I was the lead manufacturing engineer working with R&D and it was the first new project coming out of R&D Malvern incorporating lean manufacturing techniques. The steerable sheath is the most complex product we’ve built in Malvern because it has the most parts and several new unique processes. We’re already at 98% yield and labor is the smallest portion of the cost of the product.

After work: I married my wife Meredith the same week I was hired by Thomas Medical, 20 years ago, and my marriage and my career here are still going strong! Meredith and I have three teenagers – two sons and a daughter. Matthew is in college and Christopher and Sarah are in high school. I love hockey and played ice hockey at Penn State. But my real hobby passion is disc golf. Disc golf allows me to see beautiful places while playing a competitive and fun sport. I look forward to playing disc golf at the Solitude Mountain Resort in Big Cottonwood Canyon next time I am in Utah to visit HQ.

Merit Medical to Exhibit Dialysis Product Line at Controversies in Dialysis (CiDA) Conference in New Orleans, October 29-30, 2015

The world’s premier dialysis access conference will be held in New Orleans, LA. We look forward to meeting the attendees who come to CiDA to discuss unique techniques and devices for hemodialysis and peritoneal dialysis access.

Merit Medical’s full suite of innovative dialysis products are designed to help improve your patient’s quality of life when treating end-stage renal disease (ESRD).

Our comprehensive dialysis product line features long-term hemodialysis catheters and peritoneal dialysis implantation kits, catheters, and accessories. These products are designed to meet the unique clinical needs of the ESRD patient.

For every step of your dialysis procedure, Merit Medical offers high-quality products for dialysis therapy. From preparation to intervention, our products will help you achieve the clinical, economical, and procedural efficiency that is essential for delivering the best possible care.

We look forward to seeing you at CiDA!

Nate Smith
Senior Product Manager
Hemodialysis

Lynette Ruppel
Senior Product Manager
Peritoneal Dialysis

I Am Merit: Michelle Molin-Savelkoul

Michelle Molin-Savelkoul
Manager, Customer Service for Europe, Middle East, Africa (EMEA)
photo: Leon Vrijdag Fotografie

Tell us about managing Merit Medical’s Customer Service for all of Europe, Middle East and Africa: I manage Merit Medical’s customer service for our distributors, direct customers (hospitals) as well as the tender department for all of Europe, Middle East, Africa and Russia (EMEA). When I started (on November 3, 2008), there were three of us in the Distributor Customer Service department for EMEA and approximately 20 people at our facility. Over the past 7 years the number of employees increased to just over 60 people and I now manage 24 customer service employees, soon to be 25 before the end of this year!

I work from our European Headquarters in beautiful Maastricht in the very southern region of The Netherlands on the border of Belgium and Germany.

Tolerance is Key for EMEA Customer Service: The biggest (and most rewarding) challenge for our EMEA Customer Service team is working with 75 countries that speak 12 different languages. This includes 14 countries that sell direct to hospitals and 61 distributor countries. Our team services 1,830 external customers and 75 Merit EMEA sales representatives! Our team speaks Spanish, Portuguese, Danish, Swedish, Russian, English, French, German, Dutch, Norwegian, Finnish and Italian and at all times we need to make sure that someone who speaks that language is available to speak with customers calling in.

Tolerance is a very important trait to have when you work in EMEA customer service because we must be familiar with and sensitive to so many different cultures. So I’m sensitive to having a team with a good vibe and I look for people who can maintain a sense of humor while managing so many customers and nationalities.

On why it’s all important to Michelle: I once had a job opportunity to work for a company in a different industry. It didn’t feel important to me – medical devices save lives, they are important and that’s why I love this industry. This was confirmed recently when my husband David suddenly had a heart attack at age 39. Products like the ones that Merit manufactures saved his life. We got married this past weekend after 15 years of being together. I would trust Merit products to go into my husband’s body – I know that we make the highest quality and we do everything we can to produce the best we can.

What about Merit do you enjoy: Merit has a family feeling, it’s like a second home. The people in this company give you that second family feeling. And Customer Service feels to me like the center of everything. We provide all of the information to planning so they can ensure products ship on time, to finance, to logistics, to regulatory, to marketing, to the customer, internally and externally. To them we are the face of Merit.

I have especially enjoyed working with Justin Lampropoulos – he helped me move up from distributor customer service representative to my current position as Customer Service Manager for EMEA. He has motivated me all along the way. His vision for Merit to be the most customer-focused company has been my mantra for our EMEA customer service team – give every country what they need – do anything and everything we can for the customer. That’s what makes Merit very unique in our industry.

After work: On the weekends I love to take my two daughters horseback riding. Yadira is 11 and Yuna is 8. Horses really help me to destress from the week and it’s an activity we love doing together.

Merit Medical featured in Utah Business Connect magazine

Justin Lampropoulos, Executive Vice President of Sales, Marketing & Strategy for Merit Medical Systems, recently contributed the article, “The Building Blocks of Sustainable International Growth,” to Business Connect Utah magazine. In his article he shares key insights into growing a business internationally, including finding shared culture and values, developing successful channels and building a brand in a new market.

Merit Medical derives nearly 50% of its business from global markets outside the United States. This global success and Merit’s continued growth stems from smart, forward-thinking tactics as well as the company’s stated vision to deliver the best health care possible. Merit uses this universal foundation to follow through globally on its corporate vision: Each day we are determined to make a difference by understanding our customers’ needs, and innovating and delivering a diverse range of products that improve the lives of people, families, and communities throughout the world.

Read the Business Connect Utah article.

ThinkRadial™ Establishes Influential Presence at CIRSE

Largest Interventional Radiology Event of the Year Is Site for Transradial Education from Leading Industry Source ThinkRadial™
 

LISBON, PORTUGAL – September 26, 2015 – Merit Medical Systems, Inc. and its renowned ThinkRadial™ education program will host a targeted symposium at this year’s Annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting.  The ThinkRadial™ Symposium “Transradial Approach in Interventional Radiology” will provide attendees with the latest information about utilizing the radial artery for interventional radiology procedures.

ThinkRadial™ Symposium at CIRSE – “Transradial Approach in Interventional Radiology”

WHEN: Sunday, Sept. 27, 2015 – 13:00 – 14:00
WHERE: Auditorium 6
WHO: Moderator: Professor Dr. Christoph A. Binkert – CIRSE Scientific Programme Committee Deputy Chairperson, Director of Department of Radiology and Nuclear Medicine and Chief of Radiology at Kantonsspital Winterthur, Winterthur, Switzerland.

Speakers: Dr. Darren Klass, Interventional Radiologist at Vancouver Imaging, working at Vancouver General and UBC Hospitals in Vancouver, Canada; and Dr. Aaron M. Fischman, Assistant Professor of Radiology and Surgery in the Division of Vascular and Interventional Radiology at The Mount Sinai Medical Center.

Merit Medical/ThinkRadial™ Booth #45 The Merit Medical CIRSE booth will feature information about its embolics and radial product portfolios as well as ThinkRadial™, a program powered by Merit Medical that offers immersive radial training courses, advanced workshops, and ongoing education and support.

WHEN: Sept. 26 – 30, 2015
WHO: Available for briefings with the media

  • Justin Lampropoulos, Executive Vice President, Merit Medical Sales, Marketing and Strategy and recognized as one of the “40 Medtech Innovators Under 40” by the industry. 
  • Rob Jenkins, Executive Vice President, EMEA

Physicians Partner with Merit to further the field of Interventional Radiology In conjunction with CIRSE, Merit Medical has partnered with several well-respected physicians to highlight its commitment to advancing the field of interventional radiology. This powerful branding campaign called “Starts with ME,” profiles Dr. Darren Klass, Interventional Radiologist at Vancouver Imaging, working at Vancouver General and UBC Hospitals in Vancouver, Canada; Dr. Amman Bolia –Consultant Radiologist for the University Hospitals of Leicester NHS Trust in Leicester, United Kingdom and nominated for a Pioneer in Performance award by CIRSE; and Dr. Christoph A. Binkert, CIRSE Scientific Programme Committee Deputy Chairperson, Director of Department of Radiology and Nuclear Medicine and Chief of Radiology at Kantonsspital Winterthur, Winterthur, Switzerland.

The campaign demonstrates that Merit Medical is committed to a company culture that takes a listen-first approach to product development to best support its clinician customers’ efforts to advance their fields and achieve better patient outcomes.

Visit http://startswithme.com/.

To schedule an interview at the ThinkRadial booth or to attend the ThinkRadial Symposium contact: Theresa Gubler 001-801-208-1100, [email protected].

ABOUT ThinkRadial™ ThinkRadial, powered by Merit Medical Systems, Inc., is a community of clinicians and experts committed to furthering transradial access for better patient outcomes and healthcare economics. ThinkRadial provides trainings, clinical field assistance, patient resources and promotional opportunities for physicians seeking to begin or advance their transradial practice. The ThinkRadial world-class, hands-on transradial training is offered at sites in numerous countries around the globe. These courses are designed to provide comprehensive exposure to transradial interventional skills ranging from case selection and preparation to procedural logistics and equipment selection as well as a significant focus on technical skills, troubleshooting and management of complications. ThinkRadial.com, guided by an impressive roster of Board of Advisors (thinkradial.com/advisors/), provides access to a comprehensive library of peer-reviewed articles, clinical literature, books, numerous videos, and a blog on the transradial approach. Please visit www.thinkradial.com.

I Am Merit: Michelle Xu

Michelle Xu, Asian Channel Management Supervisor

Above all else, Merit Asia’s third employee, Michelle Xu, Channel Management Supervisor, enjoys working with her dedicated Merit colleagues “who never say never.”

Working for Merit Asia as it continues to grow: I joined Merit Asia five and a half years ago in 2010 as an Administration Assistant. I was the third employee then, and now, as of the end of September, we have 89 employees with Merit Asia! I enjoy working for Merit because it is a friendly, flexible and open environment to present your opinions, share your ideas and discuss better solutions. A good work ethic is always encouraged and outstanding performance is rewarded. Merit provides us with different kinds of opportunities to thrive.

Her responsibilities as Channel Management Supervisor: As Asian Channel Management Supervisor I manage 380 distributors in Mainland China and 30 distributors in Southeast Asia. My key responsibilities include conducting due diligence, legal documentation review, on-line compliance training and Agreement and Letter of Authorization as well as distributor performance evaluation and incentives calculation. In addition to my distributor responsibilities I manage sales promotion control, internal process improvements, data analysis and dealer training. Channel Management is an important function that acts like a “doorkeeper,” to monitor distributors’ qualification and activities, and like a “bridge,” to build up a channel and connect external distributors with internal Merit sales representatives. As the Channel Management Supervisor, I ensure that Merit is receiving maximum benefit from our distributors and contribute to the overall sales organization.

On what she enjoys most about Merit: No doubt, if nothing else, THE PEOPLE! People are precious to Merit. All of our incredible achievements have come from the Merit team’s continuous efforts and amazing creations. I enjoy my colleagues who are professional, dedicated and never say never. I am delighted to work with them and celebrate every milestone moment together.

How she spends her time outside of work: I am an outdoor enthusiast and like swimming, spinning, mountain climbing and hiking. I will travel around the world during my annual holiday. Reading books and cooking are also my favorites during my spare time.

I Am Merit: Sarah Spangler

Sales Engineer Sarah Spangler customizes Merit Medical products and devices for Merit’s OEM (Original Equipment Manufacturer) customers. Sarah spends her days collaborating with the OEM sales team, customers and other Merit engineers to ensure that we can provide a product that meets the customers’ needs and procedures. Watch her video interview.

I Am Merit: Ricardo Alvarez

Ricardo always tries to include his team – because his team makes him feel successful.

At Merit Medical’s newest facility in Tijuana, Mexico, Manufacturing Manager Ricardo Alvarez does everything he can to ensure his employees feel successful – because his team is what makes Ricardo feel successful.

The path to becoming the 2nd employee at Merit Tijuana: I moved my family to Tijuana in January 2014 when I accepted a position with Integra, a contract manufacturer to Merit for seven years. At Integra I assembled a high performance team to produce Merit products with high standards for Safety, Quality, Delivery and Costs. This April, I had the privilege to become part of the Merit family as the Manufacturing Manager and second employee at the new Merit Tijuana Mexico Plant.

Ricardo’s Hiring Philosophy: I currently have 190 total employees covering Engineering, Facilities, Maintenance and Production. I always try to include my team because my team makes me successful. When I hire I look more at personality and values. I take interviewees to the manufacturing floor to see whether they are passionate and enjoy what they do. Technical skills can be learned, but personality and values is so important because they need to fit well with the team and the company’s vision.

How Ricardo Shapes the Merit Culture in Tijuana: Right now we’re the new kids on the block in Tijuana. But my goal is for employees to stay here a long time because many on our corporate team have 15-20 years seniority! And I believe we can achieve that goal if we follow the Merit culture treating people the best we can and looking after our employees’ personal lives. For example, here at Merit we provide free transportation to and from work, lunch and snacks and life insurance – these benefits are not typical around Tijuana and we want to be the best!

On his Commitment to Work and Family: My passion is Manufacturing Operations and I feel a high degree of responsibility to ensure every single device is manufactured with quality, delivered on time, meets standard costs and exceeds the expectations of our customers, so they can use my products or any other Merit device to improve their quality of life. My best hobby is my family: my wife Alessandra Aranda is my motivation, she supports me in many ways, listening, coaching and living in the manufacturing world with me. We have two children, Constanza age 9, she loves to do yoga, and Andre who is 2 is getting ready to play Soccer! We enjoy biking or simply watching a movie together and the best feeling is to end up the week every Sunday with the work done and the family happy!

I Am Merit: Maeve Harris

Maeve Harris

The large decal on the wall of Maeve’s pack area was her unique idea to make the room special and different. It remains one of the most colorful work spaces throughout all of Merit’s facilities

At Merit Medical’s Galway facility, Quotes and Samples Analyst, Maeve Harris, enjoys meeting directly with physician customers and helping them find solutions that make their jobs more efficient.

Maeve’s Unique Role at Merit Medical: A Merit sales rep from Europe or a distributor from the Middle East or Asia will come to me if one of their physician customers wants a procedure pack. They’ll tell me what they want in that procedure pack and I’ll price it out and build a non-sterile sample to send to the customer. The procedure pack will include everything the doctor needs for that specific procedure, from devices to accessories that Merit doesn’t manufacture, like drapes. These packs save a lot of time for the hospitals and make the doctor’s job more efficient. Once the doctor orders the pack, my job is done until they want to make a change – then they come back to me.

Why she loves coming to work every day: The doctors come to our Vision Building in Galway to meet with me and pull product from our shelves. We collect it all in the pack work area and I build the pack with the customer. I get to meet many new people all the time – our international sales reps and our customers. Every day is different. I really enjoy being able to find solutions for our customers and seeing their appreciation for the opportunity to visit the beautiful Merit facility and the customized efforts we make on their behalf.

On why she stays settled at Merit: I grew up in the middle of Ireland. I’ve lived in several places, as distant as Australia. I’ve tried a few different careers. I was a bit of a wanderer until I moved to Galway to work for Merit six years ago. I started on the production line and later became team leader, eventually helping to start Merit’s custom packs business in 2012 – the first production lot was very exciting! I feel very lucky to have been moved up from production – Merit has given me opportunities. There’s always something new for me to learn here and it keeps me going.

After work: I love hiking in the mountains and beauty of Ireland. I come from a large family – four sisters and one brother and my nieces keep me very busy!

If you could send one message to our customers: Merit provides a very individually tailored product and experience for our customers. Other companies claim that they customize, but they don’t customize like we truly do.

Successful Summer ThinkRadial Training Course

The ThinkRadial team is grateful to the clinicians who came from around the US and England to join them for the two-day training course hosted at Merit Medical’s beautiful campus in Salt Lake City, Utah. The program was kicked off on Thursday with welcome remarks, a tour of the facility and an enjoyable evening welcome reception with Merit and the course attendees.

TR1

Dr. Sandeep Nathan of the University of Chicago, Associate Professor of Medicine and Director, Interventional Cardiology for the University of Chicago Medical Center, was the featured faculty presenter. Beyond his engaging presentations and demonstrations on transradial approach, Dr. Nathan fielded many questions from attendees regarding potential roadblocks, which devices to use and when and how he would approach certain complications that could arise. At the end of the course Dr. Nathan provided his contact info to attendees so they could send him questions once they were back in their own practice.

TR2

On Friday evening, the ThinkRadial team organized a trip to the charming mountain town of Park City so the group could see the area. Before heading home on Saturday, attendees participated in a lively review of potential transradial complications and how to address them.

ThinkRadial is looking forward to hosting another group of clinicians at the next course scheduled for September 24-26 at the beautiful Merit Medical Vision Building in Galway, Ireland—then back to Utah October 22-24th. Click here to learn more and to register: https://thinkradial.com/for-clinicians/courses/

I Am Merit: Connie Ackerman

Connie Akerman

Merit Medical’s Production Planning Manager on her approach to Planning, her work/family balance and how she takes her responsibilities “personally.”

Connie’s History with Merit: “I’ve worked with Fred (as in Fred Lampropoulos, Founder, Chairman and CEO of Merit Medical) for more than 32 years, starting in 1983 at Utah Medical. I started on the production line and moved up through several positions to Planning. Fred brought me to Merit Medical’s Planning Department in 1991 as a Planner for our production and molding facilities. In 2011, I was promoted to Manager of Production Planning for all manufacturing out of Merit’s Utah HQ and today I manage seven, soon to be eight Planners.”

Her Loyalty to Merit Medical: “Fred’s dedication, drive and commitment to his employees makes Merit feel like a home away from home. Fred is just as committed to the people here as he is to the business. And that’s why we’ve grown like we have – it’s incredible to see how far we’ve come! Sometimes you just want to say slow down!! But he just keeps going. Fred has inspired my work ethic and set my drive. I’m not sure I could work for someone other than Fred or anywhere other than Merit for these reasons.”

On her Approach to Planning: “I see Planning as the hub of Merit. We could stop a hospital from completing procedures if a product doesn’t get there. Therefore my job is an important step in saving a patient’s life – and I take this responsibility personally. This drives me in everything I do, from my persistent personality to get things done, to hiring Planners who share this same drive. I’m going to do everything in my power to make sure we meet our customers’ needs by getting their orders to them on or ahead of time. We love to beat lead times! We have the strongest planning department we’ve ever had – everyone is proactive and communication flows freely between us and the Customer Service department to ensure our customers have the best experience possible.”

After Work: “When I leave the office my family is my life. I’m married to Rob and we have two kids – Jacob who is 18 and will be leaving for college in the fall, and Kallie, 16, who just got her driver’s license! My kids are my everything to me – we love hanging with our two dogs, camping and 4-wheeling together. At night when I get home I do mom stuff – cook, clean, etc. Late at night I can’t resist reading my Merit emails – but when I’m home – being a wife and a mom is my priority.”

1500 Shipments Per Day. Delivery to over 100 Countries. 20 Languages Spoken.

It’s not FedEx. It’s not UPS. It’s not TNT. It’s a global medical device company: Merit Medical. Today Merit Medical opened its recently expanded Europe, the Middle East, and Africa (EMEA) distribution center and corporate office in Maastricht, the Netherlands. This advanced distribution center and the service it provides hospitals, physicians, and nurses in more than 100 countries throughout the EMEA region shows Merit Medical continuing its quest to be the most customer-focused company in healthcare.

Merit Medical’s ConcierGE® Guiding Catheter Now Available in Radial-Specific Shapes

Minimizing the number of catheter exchanges is important for transradial interventions in order to reduce the likelihood of spasm.1 Using catheters with radial-specific shapes may help radial operators minimize the number of catheter exchanges that can result in spasm.1

To meet the needs of radial diagnostic and interventional procedures, Merit Medical now offers the Ultimate 1 shape in both diagnostic catheters and ConcierGE® Guiding Excellence catheters with radial-specific shapes.

ConcierGE has approximately 30% more kink resistance2 and better torque response3 than the leading guiding catheter brands.

Cardiologists will now have the ability to match their guiding catheter to the shape of their diagnostic catheters, helping to reduce the need for multiple catheter exchanges.

Merit’s Performa Ultimate™ diagnostic cardiology catheters include four radial–specific shapes including the Ultimate shape, which can be used in both right and left coronary arteries using a single catheter.

ConcierGE and Performa Ultimate–more shapes give radialists more options for successful access.

Guido Sanduilli
Marketing Director
Cardiovascular Division

1 Kwan et al, http://www.ptca.org/radial/optitorque_kwan.html
2 Data on File. Test results are based on 6F guide catheter comparison.
3 Data on file. At ½ hub rotation.

InQwire® Diagnostic Guide Wire Available in Baby J Configuration To Facilitate Transradial Intervention

Manipulating diagnostic guide wires through radial vasculature can sometimes be a little more complex than the pathways used during femoral access. To help facilitate radial navigation, Merit offers its InQwire diagnostic guide wire in both the standard J 3.0 mm curved tip as well as a 1.5 mm smaller ”baby” J tip configuration. The smaller, more closed J tip can help you navigate through the vasculature without selecting unwanted branches along the pathway.

The InQwire guide wire is precoated over the entire wire surface for smooth, consistent coverage that resists flaking. Smooth PTFE coating means less friction which improves trackability, lubricity, and durability. InQwire wires also have precise J-tip memory that ensures tip shape retention during utilization.

Catalog Code
Diameter
J Tip
Length
Configuration
IQ35F210J1O5
0.035″
(0.89 mm)
1.5 mm
210 cm
Standard
IQ35F210J1O5F
0.035″
(0.89 mm)
1.5 mm
210 cm
Firm
IQ35F210J3
0.035″
(0.89 mm)
3.0 mm
210 cm
Standard
IQ35F220J3
0.035″
(0.89 mm)
3.0 mm
220 cm
Standard
IQ35F260J1O5
0.035″
(0.89 mm)
1.5 mm
260 cm
Standard,
Exchange
IQ35F260J1O5F
0.035″
(0.89 mm)
1.5 mm
260 cm
Firm
Exchange
IQ35F260J3
0.035″
(0.89 mm)
3.0 mm
260 cm
Standard
Exchange

Having the right tools for your radial procedure provides the efficiency and effectiveness that can help ensure a successful outcome for your patients. Contact your local Merit Sales Representative to learn more about InQwire for radial and our extensive line of products for radial approach.

Penny Goldman
Senior Product Manager

Merit Medical EP Group Announces Launch of HeartSpan® Steerable Sheath Introducer

Merit Medical continues to add to its extensive line of products for Electrophysiology. The HeartSpan Steerable Sheath Introducer offers control, coverage and comfort for Electrophysiologists when navigating cardiac chambers. The 8.5F HeartSpan Steerable Sheath Introducer’s braided construction provides kink resistance and curve durability. The distal tapered tip creates a smooth transition from the dilator to sheath introducer to reduce trauma to the atrial septum.

CONTROL 

  • Softer, flexible tip
  • Smooth transition from dilator
  • Responsive curve deflection
  • Braided construction for kink resistance

COVERAGE 

  • Bidirectional (180-degree) deflection
  • Small curl (16.4 mm)
  • Medium curl (22.4 mm)
  • Large curl (36.0 mm)

COMFORT 

  • Ergonomic shape
  • Improved grip size

The HeartSpan line of products also includes the HeartSpan® Fixed Curve Braided Transseptal Sheath with braided steel shaft for excellent torqueability and the HeartSpan® Transseptal Needle designed to be exceptionally responsive with enhanced stiffness.

Our EP team is excited to introduce this new steerable sheath designed to help EPs extend their options.

Merit Offers Radial Internal Mammary Catheter for Navigating LIMA Grafts

Transradial cardiac catheterization in patients with previous coronary artery bypass graft surgery can be technically challenging.

Impress

Since the majority of CABG patients have a left internal mammary artery (LIMA) graft to the left anterior descending artery (LAD), many radial operators choose to perform catheterization procedures in CABG patients from a left radial approach using standard femoral diagnostic catheters. However, other operators have reported success with the right radial access to the LIMA. Right radial access for right radial LIMA angiography provides more comfortable access from the right side of the patient, reduces back strain, and the need to reach over the patient, especially patients who are obese.

For patients with LIMA grafts, Merit Medical now offers a Radial Internal Mammary catheter to facilitate navigation to the left internal mammary from the right transradial approach. The Merit Radial Internal Mammary catheter is available in 4F and 5F, 110 cm lengths. The Impress® material offers a highly torqueable shaft with a soft, tapered atraumatic tip.

Combining Merit’s broad offering of products for radial approach with your clinical expertise can help achieve the improved outcomes you expect from the radial approach including reduced complications, quicker ambulation, and increased patient comfort.

For more information about the Impress Radial Internal Mammary catheter and Merit’s growing portfolio of products for your radial procedures, visit the product page on merit.com.

Tami Anderson
Senior Product Manager

Malagari Safety and Efficacy Study of HCC TACE with HepaSphere™ Microspheres 30-60µm

Malagari photo of doc

Dr. Katerina Malagari et al conducted a study of 45 patients with hepatocellular carcinoma (HCC) treated with the new 30-60 µm size HepaSphere Microspheres. The study found that “TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality.”1 The overall objective response from the study was “(CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9% of cases.”1 The results were published in Cardiovascular Interventional Radiology in February 2014.

HepaSphere 30–60 µm is a new size of a loadable microsphere that has a dry caliber of 30–60 µm that expands to 166–242 (197 ± 31) µm in saline and 145–213 (148 ± 45) µm after loading with doxorubicin. HepaSphere Microspheres’ unique properties offer the following advantages:

Targeted:       Flow directed due to spherical shape.

Absorbing:     Rapidly absorbs aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI.*

Conforming: Compresses in the vessel lumen, providing more surface contact with vessel intima.

Expanding:    Expands up to four times the stated dry diameter when hydrated.

HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: Embolisation of hepatocellular carcinoma and embolisation of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

Antonio Rivera
Senior Product Manager
1 Malagari K, Pomoni M, Moschouris H, Kelekis A, et al. Chemoembolization of hepatocellular carcinoma with Hepasphere 30-60 . Safety and efficacy study. Cardiovasc Intervent Radiol. 2014 Feb;37:165-175.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.

Next Generation of the Merit Snares iPad® App Is Now Available

I am pleased to announce the availability of the next generation Merit Snares for iPad. This app is designed to help customers when selecting the appropriate EN Snare® or ONE Snare® product configuration for use in a desired vessel. The app also provides the technical product code specifications for reference and ordering purposes.

Interested in downloading Merit Snares for iPad? You can download it from the App Store via the following link: https://itunes.apple.com/us/app/merit-snares/id951074703?ls=1&mt=8

Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare Endovascular Snare Systems go hand-in-hand to provide physicians with both single loop and triple loop options to help meet clinically-challenging case that may arise.

Jesse Hansen
Director of Marketing

Klass Doxorubicin Dose Escalation Study Examines Dose & Delivery for the Treatment of HCC

The purpose of Dr. Darren Klass, et al’s study — “The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatocellular carcinoma: a dose escalation study” — was to investigate “the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma (HCC).”1  The study included 25 patients, randomly assigned and divided into 4 subgroups each receiving bland, 25 mg, 50 mg, 75 mg of doxorubicin-loaded HepaSphere™ Microspheres.

Klass and his colleagues published the following results:

  • 56% of patients demonstrated complete response according to EASL criteria as opposed to 0% according to RECIST (v1.0) criteria.
  • Residual tumor was identified in all groups (0 mg: 35%±28.5%; 25 mg: 42%±30.4%; 50 mg: 3.6%±3.3%; and 75 mg: 49.29%±32.6%).
  • No difference was noted between bland embolic and drug-loaded groups. Subset analysis did demonstrate a significantly increased degree of necrosis in the 50 mg-loaded group (p=0.018).
  • Strong correlation existed between arterial phase Computer Tomography EASL-based response and histopathology (r=0.81; p<0.0001).

The study concluded that “Histology correlates strongly with one-month post-procedural imaging and response optimized at 50 mg of loading per vial. Adverse events were a reflection of embolization, with no relationship between loading dose or administered dose of doxorubicin.”

Merit Medical’s HepaSphere Microspheres are indicated for use in embolization of blood vessels with or without delivery of doxorubicin HCI for therapeutic or preoperative for the embolization of hepatocellular carcinoma and embolization of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

HepaSphere Microspheres offer targeted embolization that is flow directed due to their spherical shape, they rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI,* and compress in the vessel lumen, providing more surface contact with vessel intima. HepaSpheres expand up to four times the stated dry diameter when hydrated. For more information on HepaSphere Microspheres, go to the HepaSphere product page or contact us.

Antonio Rivera                                                                                                                                                                                                                                                                                                                                   Senior Product Manager

 

1 Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Research. 2014 Jul;34(7):3597-3606.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.

 

Merit Medical To Exhibit Dialysis Product Line at American Society of Diagnostic and Interventional Nephrology (ASDIN) in Orlando, February 13-15, 2015

Merit Medical is exhibiting at the 11th Annual Scientific Meeting of the American Society of Diagnostic and Interventional Nephrology in Orlando, Florida to introduce attendees to its expanding line of Hemodialysis and Peritoneal Dialysis products. The Merit Medical dialysis product suite includes the following key products:

  • The CentrosFLO® Hemodialysis Catheter, invented by Dr. Stephen Ash, was shown in a recent retrospective study to have statistically greater patency after three months due to its self-centering, curved-tip catheter which is designed to reduce thrombosis and fibrin sheath formation.1
  •  

  • The ProGuide™ Hemodialysis Catheter has a step-tip with an appositional bump design intended to reduce arterial insufficiency by keeping the tip of the catheter from sucking up against the vessel wall. The ProGuide is well known as an exchange catheter due to its easy, over the wire placement capability.
  •  

  • The Flex-Neck® line of Peritoneal Dialysis Catheters allow for up to 35% higher flow rates than other catheters currently on the US market. The Flex-Neck Classic and ARC shapes are designed to accommodate various tunneling techniques and exit site options. Our unique Implantation Systems are designed to streamline your specific implantation technique.
  •  

  • The Merit Percutaneous Implantation Kit for peritoneal dialysis (PD) catheter placement is designed to accommodate stylet or over-the-wire placement using ultrasound-guided access and fluoroscopy. To see how the kit is used, watch the PD Percutaneous Implantation Video.

Visit Merit Medical at Booth 207 to learn more about this broad line of products designed to enhance the practice of dialysis interventions and catheter placements.

Nathan Smith
Senior Product Manager
  Lynette Ruppel
Senior Product Manager

1Data on file

ONE Snare® Microsnare Sizes Approved for Sale in Europe

Merit Medical’s ONE Snare microsnare sizes are CE marked and available for sale in Europe. These new ONE Snare product configurations are available in loop diameters of 2 mm, 4 mm and 7 mm, with a 2.3F – 3F snare delivery catheter.

The ONE Snare suite of endovascular snares are now available in 15 kit configurations with 10 loop diameters ranging from 2 mm to 35 mm. These sizes complete the suite of ONE Snare product configurations and give physicians additional choices and options when foreign body manipulation or retrieval procedures arise. Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare® Endovascular Snare Systems go hand-in-hand to provide physicians with both single-loop and triple-loop options to help meet any clinically-challenging case that may arise, because having options matters.

To learn more, visit the ONE Snare product webpage.

Merit Medical Showcased Products for Lead Implantation at International Symposium on Clinical Pacing in Rome

I’ve just returned from the XVI International Symposium on Progress in Clinical Pacing that was held in Rome, Italy. The symposium was a big success. Merit Medical was a sponsor of this meeting dedicated to the treatment of cardiac arrhythmias where innovation and new diagnostic and therapeutic techniques are discussed.

Dr. Seth J. Worley of Lancaster, Pennsylvania was one of the Course Directors of a half-day symposium on Interventional Device Implantation that was conducted over three sessions with Dr. Buongiorni from Pisa, Italy and Dr. Torkel Steen from Oslo, Norway as co-chairs. Some of the topics discussed were:

  • “How to Cross a Subclavian Occlusion for Venous Access”
  • “Snares for LV Lead Implantation: the most powerful technique for difficult LV lead insertion that often replaces venoplasty and anchor balloons”
  • “Interventional vs. Traditional Approach to Device Implantation”

Dr. Worley is the inventor of Merit’s Worley™ LV Delivery System. This telescoping system provides the options and tools needed to overcome the challenges of complex LV lead location and to help deliver leads, even in difficult cases. Clinical evidence has shown that a telescoping support catheter system can reduce implantation times, provide easier access to the target vessel, and improve chances for successful CRT implantation.1

To learn more about Merit’s products for CRT implantation, click on the links below.

Worley™ Advanced CSG

Worley™ Advanced LVI

Worley™ Vein Selector

Matt Toone
Marketing Director, EP

1 Jackson KP, Hegland DD, Frazier-Mills C, Piccini JP, Koontz JI, Atwater BD, Daubert JP, Worley SJ. Impact of using a telescoping-support catheter system for left ventricular lead placement on implant success and procedure time of cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2013 May; 36(5):553-8.

ReSolve® Biliary Locking Drainage Catheter receives 510(k) clearance!

I am pleased to announce that the ReSolve® Biliary Locking Drainage Catheter has received 510(k) clearance and is available for sale in the US.

The ReSolve Biliary Locking Drainage Catheter has been available in Europe since July of this year and has had good success.

These catheters are indicated for drainage of bile within the biliary system. Often biliary systems need to be decompressed due to bile duct stones, extrahepatic, or intrahepatic tumors, and primary sclerosing cholangitis, among other reasons. In addition bile may also need to be diverted from a bile duct leak.

Biliary system lesions do not always occur in the same location in every patient. Because of this, Merit offers catheters with two different drainage hole configurations to accommodate patient anatomy and multiple disease locations.

Correct catheter positioning is important in these procedures. The catheter features a radiopaque marker band near the proximal shaft drainage hole, and non-radiopaque depth markers the entire length of the catheter to help with fast and accurate positioning.

Additional features:

  • Atraumatic pigtail
  • Smooth transitions
  • Large drainage holes
  • Hydrophilic coating
  • Kink resistance

To learn more, check out the ReSolve® Biliary Locking Drainage Catheter product webpage.


Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Ostial PRO® Debuts in Turkey

Ostial PRO in Turkey

Merit Medical’s Ostial PRO Stent Positioning System was recently used for the first time in Turkey. The case was a renal aorto-ostial lesion performed by a cardiovascular surgeon at a University Hospital.

“The case went very well, and the cardiovascular surgeon liked the product very much,” Bahadir Şenol, Merit Medical Clinical Sales Specialist, said. “The surgeon plans to purchase additional Ostial PROs to have on-hand as they are needed.”

The Ostial PRO stent positioning system is an alignment tool with gold-plated “feet” that engage the aortic wall and allow easier assessment of the coronary or renal ostia, improving accuracy of stent positioning. In clinical studies, the Ostial PRO significantly increased the accuracy of aorto-ostial stent placement.1

“This is a product that can save lives,” Şenol said, adding that Merit Medical offers clinical support to doctors and hospitals that are interested in utilising the Ostial PRO. To learn more, contact your Merit Sales Representative or visit the Ostial Pro page on our website, which features a product video, several case studies, and documents such as brochures and instructions.

1 Data on file.

New Video Showcases Radial Portfolio

A new video showcases our extensive Radial portfolio, which includes products that support your radial procedure every step of the way – from preparation to hemostasis – providing procedural efficiency.  The new video highlights the benefits of radial access and includes our newest radial products, including the PreludeEASE™ Hydrophilic Sheath Introducer and the Rad Board® Radial Arm Board. To watch the new video, visit “Our Radial Products” on the Think Radial page.

Scion Clo-Sur P.A.D. to be included in Companion to Braunwald’s Heart Disease Textbook

Merit Medical was recently notified that an illustration featuring the Scion Clo-Sur P.A.D will be included in Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease, first edition by Deepak L. Bhatt MD. The book’s publication date is May 2015. Braunwald’s Heart Disease is a textbook of cardiovascular medicine. It is updated frequently to include the latest clinical trials, new research, and updates on clinical practice for practitioners, physicians-in-training, and students of cardiology. The author, Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC is a Professor of Medicine, Harvard Medical School and Executive Director, Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center, in Boston, Massachusetts. He has authored or co-authored over 700 publications. Dr. Bhatt is the Editor of the peer-reviewed Journal of Invasive Cardiology, Chief Medical Editor of Cardiology Today’s Intervention for healthcare professionals, and Editor-in-Chief of the Harvard Heart Letter for patients.

The Clo-Sur P.A.D. is a non-woven topical pad made with a proprietary polyprolate, a positively-charged material that reacts with negatively-charged red blood cells to accelerate clotting. The Clo-Sur P.A.D. promotes hemostasis and the Clo-Sur PLUS P.A.D.™ promotes hemostasis and is indicated as an antimicrobial barrier.

The book’s illustration depicts how the Clo-Sur P.A.D.’s positive charge which reacts with negatively charged red blood cells to accelerate clotting in the tissue tract.

To learn more about the Clo-Sur P.A.D., watch the product video or Contact Us.

Mark Heninger
Senior Product Manager

ONE Snare® Endovascular Snare System Microsnare Sizes Receive FDA 510(k) Clearance

I’m pleased to announce that ONE Snare microsnare sizes are FDA 510(k) cleared and available for sale in the United States.

ONESnareThese new ONE Snare product configurations are available in loop diameters of 2 mm, 4 mm and 7 mm with a 2.3F-3F snare delivery catheter. The ONE Snare suite of endovascular snares are now available in fifteen kit configurations with ten loop diameters ranging from 2 mm to 35 mm. These sizes complete the suite of ONE Snare product configurations and give physicians additional choice and options when foreign body manipulation or retrieval procedures arise.

Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare® Endovascular Snare Systems go hand-in-hand to provide physicians with both single loop and triple loop options to help meet any clinically-challenging case that may arise, because having options matters.

To learn more, visit the ONE Snare product webpage.

Jesse Hansen
Marketing Director

Merit Medical Exhibiting at 2014 VEITH Symposium in New York on November 18-22

Merit Medical is proud to support the VEITH Symposium, celebrating its 41st year, in New York City. Attendees for this meeting include vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists.

If you plan to attend VEITH, please make sure to stop by our booth to learn more about our latest innovations from access to intervention. Some of these unique devices include:

From preparation to intervention, our products are designed to help achieve the clinical, economical, and procedural efficiency that is essential for delivering the best possible care.

Look forward to seeing you at VEITH!

Jesse Hansen
Marketing Director

Merit Medical Donates PD Catheters for Stuffed Animals to Comfort Young Patients

image1-16Recently we heard from a pediatric nephrology nurse at the Johns Hopkins Children’s Center who requested a number of our pediatric Flex-Neck® peritoneal dialysis catheters on behalf of Tubie Friends™. They wanted to give their young patients a furry friend who has a PD catheter just like theirs, with hopes of making the process less frightening. We were more than willing to donate to this worthy cause.

The sales and marketing staff at Merit Medical worked together to provide the requested catheters. We were pleased to see the end result, this adorable PD Bunny pictured here. The PD nurse said the response from the patient was priceless: “It looks just like me!”

image2-18Tubie Friends is a non-profit group that was founded by two mothers of children with implanted feeding tubes. These moms wanted to make life easier for children who are receiving treatment through PD catheters or tubing.

Tubie Friends are not only donated to patients but also sold to raise funds for the organization. These comforting toys have been used as a teaching tool for family, friends, school nurses, and caregivers to help children become comfortable and less fearful of implanted tubes and catheters.

If you’d like more information about Merit Medical’s complete line of peritoneal dialysis products, please Contact Us.

Lynette Ruppel
Senior Product Manager

image3-21

HepaSphere Microspheres Absorb Both Mechanically and Ionically for Optimal Doxorubicin Loading

HepaSphere Microspheres are super absorbent polymer (SAP) microspheres made from vinyl acetate and methyl acrylate that combine to form a copolymer–sodium acrylate alcohol copolymer.

How do they work? HepaSphere Microspheres have the ability to load doxorubicin two ways: mechanically and through ionic interaction. Through mechanical interaction, HepaSphere Microspheres rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI* and expand up to four times the stated dry diameter when hydrated. A recent study found that SAP have the ability to load 50 and 75 mg doxorubicin with ease of handling and optimal efficiency through dry loading.1

* Doxorubicin HCl used with HepaSphere Microspheres should be reconstituted with saline; never use pure water.

High Drug Loadability

MECHANICAL INTERACTION – HepaSphere Microspheres act as a reservoir and mechanically absorb aqueous solutions.

HepaSphere Mechanical Interaction

IONIC INTERACTION – The doxorubicin is loaded and eluted by a reversible ionic exchange mechanism.

HepaSphere Ionic Interaction

In the ionic interaction, the dry HepaSphere’s anionic polymer is negatively charged and absorbs the doxorubicin, which is positively charged or cationic.

Increased Tumour Necrosis

In a study on an animal model, the doxorubicin loading and efficiency of polyvinyl alcohol sodium acrylate copolymer microspheres were tested. The results found that Merit’s microspheres “can be efficiently loaded with doxorubicin” and that “histopathological tumour necrosis at 7 days was more prominent in the group treated with doxorubicin-loaded microspheres than in the bland embolisation group.” Both in vitro and in vivo studies showed a high drug loadability and sustained drug release over time, high intratumoural doxorubicin concentrations at each time point, and on histopathology, increased tumour necrosis.” 2

Efficient Loading

A study of doxorubicin eluting beads shows the difference in loading between HepaSphere Microspheres and another embolic brand. The study found that the competitor’s bead loaded only on the outer 20 microns of the bead. HepaSphere loads doxorubicin throughout the sphere.

HepaSphere Microspheres load doxorubicin throughout the microsphere.

HepaSphere bead

Competitor Bead – Confocal laser scanning microscopy images of dox-loaded beads (25 mgm/mL 500-700 micron bead). Image (below) shows progressive sections from the outside inwards at 10 micron intervals.3

HepaSphere bead competitor

For more information on HepaSphere Microspheres and loading of doxorubicin, explore the product’s website page or see our step-by-step reference guides:

HepaSphere Microspheres Lyophilized Doxorubicin Mixing Chart

HepaSphere Microspheres Presolubilized Doxorubicin Mixing Chart

The Merit Medical Embolics Team is ALWAYS available to answer any questions about our Embolics Portfolio. Contact Us.

Antonio Rivera, BSRT, MSHS

Global Product Manager

——————————————–

HepaSphere Microspheres are not approved or available for sale in the United States. In the European Union, HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the embolisation of hepatocellular carcinoma and the embolisation of metastases to the liver.

References

  1. Liu DM, Kos S, Buczkowski A, Kee S, Munk PL, Klass D, Wasan E. Optimization of doxorubicin loading for superabsorbent polymer microspheres: in vitro analysis. Cardiovasc Intervent Radiol. 2012 Apr;35(2):391-8.
  2. Lee KH, Liapi EA, et al. Doxorubicin-loaded QuadraSphere Microspheres: Plasma pharmacokinetics and intratumoral drug concentration in an animal model of liver cancer. Cariovasc Intervent Radiol. JUN 2010; 33(3):576-582.
  3. Lewis LL, Gonzalez MV, Leppard SW, Brown JE, Stratford PW, Phillips GJ, Lloyd AW. Doxorubicin eluting beads-1: Effects of drug loading on bead characteristics and drug distribution. J Mater Sci. Sep 2007;18(9):1691-1699.

 hepasphere

 

 

Study Finds Use of Hemostasis Patch Significantly Reduces Risk of Femoral Artery Compromise in Children

closurepadCardiac Interventions News presented in its May/June issue a study at the 2014 scientific sessions of The Society for Cardiovascular Angiography and Interventions (SCAI) entitled, “Femoral Artery Compromise from Cardiac Catheterization in Children–a Multicenter Study by the CCISC (Congenital Cardiovascular Interventional Study Consortium)” by Thomas J. Forbes, MD. The study concluded that the use of a 3 Fr sheath and hemostasis patch significantly reduced the risk of femoral artery compromise. The study found that “…when a ahemostatic patch was used to seal the wound, the risk of femoral compromise was reduced by approximately two-thirds compared with manual pressure alone.”

The Scion Clo-Sur PLUS P.A.D.™, sold by Merit Medical, is a sterile topical hemostasis pad intended for the local management of bleeding wounds, including vascular procedure sites.

To learn more about the Scion Clo-sur PLUS P.A.D., please visit the product’s web page, or contact your Merit Medical Sales Representative.

Mark Heninger
Senior Product Manager

 

VIVA 2014 Quality Improvement Call to Action Includes Sessions on Ultrasound-Guided Vascular Access and Micropuncture Technique

One of the risks of vascular access is the inadvertent vascular puncture of the posterior wall, side branches, and veins. It can lead to increased hemorrhagic risk in anticoagulated patients, hematoma, or pseudoaneurysm. Because this is such a common problem for clinicians and their patients, this year’s VIVA (Vascular Interventional Advances) meeting is including a Quality Improvement Call to Action on ultrasound-guided vascular access that includes sessions on micropuncture technique.

Merit Medical invites VIVA attendees to visit our booth to learn more about the Merit MAK™ and S-MAK™ mini access kits designed to support micropuncture technique. These mini access kits for the percutaneous placement of 0.035″ (0.89 mm) or 0.038″ (0.97 mm) guide wires include

NEEDLE

  • 21G, smaller needle to minimize trauma and bleeding
  • 4 cm, 7cm and 9 cm lengths
  • Standard MDX coating reduces insertion force and drag
  • Echo-enhanced tip option

GUIDE WIRE

  • Stainless steel and Nitinol mandrel core wires
  • Tip options: stainless steel, platinum or palladium
  • 40 cm, 60 cm and 80 cm lengths
  • 0.018” diameter

INTRODUCER

  • Excellent transitions from dilator to introducer
  • Smooth insertion
  • 4F-5F sizes
  • 10 cm and 15 cm lengths

DILATOR

  • Excellent transitions from wire to dilator
  • MAK for all applicable vascular access sites.
  • S-MAK has a stiffened dilator for placement in scar tissue, tougher skin, calcified or diseased vessels, or obese patients.

GUIDE WIRE ALIGNMENT DEVICE

  • BowTie™ offers an elegant solution to the problem of aligning micro guide wires with devices for quick and easy insertion.

We’re looking forward to seeing you at VIVA November 4-7 at the Wynn in Las Vegas. Until then, you can find more information on Merit’s extensive line of products for vascular access on merit.com.

Chan Ream
Product Manager
Vascular Access

Merit Medical to Exhibit Dialysis Product Line at Controversies in Dialysis (CIDA) Conference in Salt Lake City, October 23-24, 2014

The world’s premier dialysis access conference is coming to Salt Lake City. We look forward to meeting the attendees who come to CIDA to discuss unique techniques and devices for hemodialysis and peritoneal dialysis access.

Merit Medical’s full suite of innovative dialysis products can help you improve your patient’s quality of life when treating end-stage renal disease (ESRD).

Our comprehensive dialysis product line features long-term hemodialysis catheters and peritoneal dialysis implantation kits, catheters, and accessories. These products are designed to meet the unique clinical needs of the ESRD patient.

For every step of your dialysis procedure, Merit Medical offers high-quality products for dialysis therapy. From preparation to intervention, our products will help you achieve the clinical, economical, and procedural efficiency that is essential for delivering the best possible care.

We look forward to seeing you at CIDA!

Nate Smith
Senior Product Manager
Hemodialysis

Lynette Ruppel
Senior Product Manager
Peritoneal Dialysis

Merit Medical Announces The Launch Of The SureCross® Support Catheter

Merit Medical is pleased to announce the launch of the Merit SureCross® Support Catheter. The SureCross is used to guide and support guide wires, traverse vasculature, facilitate guide wire exchanges, and deliver infusions of saline, contrast, and therapeutic agents. It is designed to give physicians trackability, pushability, and visibility when treating patients with difficult occlusions resulting from peripheral arterial disease (P.A.D.).

TRACKABILITY – SHAFT TECHNOLOGY 

  • 40 cm distal hydrophilic coating for smooth tracking through tortuous anatomy
  • Maximum infusion pressure of 300 psi

PUSHABILITY – GUIDE WIRE COMPATIBILITY 

  • Low profile seamless transition from catheter to guide wire for exceptional crossing support
  • Matches guide wire outer diameter (OD) within 0.001″ for added strength and pushability

VISIBILITY – TIP DESIGN 

  • Translucent shaft for improved visualization
  • 3 platinum marker bands to confirm positioning
  • Internal platinum distal marker band
  • 2 mm distance from tip to marker band for accuracy of tip location

image2-19
Contact your Merit Sales Representative to evaluate the SureCross Support Catheter today.

Tami Anderson
Senior Product Manager

Updated Version of Merit Convert App now Available in the iPhone App Store

An updated version of Merit Medical’s popular iPhone Convert App was launched with the release of the iPhone 6 and IOS8. Merit Convert is a handy tool for anyone with measurement conversions including area, length, mass, temperature and volume. For those in the Medical Device industry, the app also contains an artificial aging calculator, flow and pressure conversions and needle gauge and French size charts. There’s also a handy work week calendar so you can quickly determine the week that you’ll start and finish projects.

The Merit Convert App Version 1.4 includes minor design updates and bug fixes. To update the App if it’s already on your iPhone or to download the App for the first time, please visit the App Store on your iPhone. If you enjoy using the App, please take a moment to rate it!

To learn more visit www.meritoem.com/merit-convert-app.

Michelle Stevens
Merit OEM Senior Marketing Communications Manager

       

Catheter Patency is Vital for Patients with End-Stage Renal Disease

Catheter patency is vital for the delivery of hemodialysis and effective, long-term vascular access for patients with end-stage renal disease. Tunneled catheter thrombosis, as a result of venous thrombosis or the formation of fibrin sheaths, is a leading cause of catheter failure. Thrombosis can occur when the distal tip of the catheter comes in contact with the vessel wall, which can lead to vessel wall injury and fibrin sheath formation. The tip designs of many available long-term hemodialysis catheters on the market today allow for the tip of the catheter to come in contact with the vessel wall.

The CentrosFLO represents an innovative approach to the design of long-term hemodialysis catheters. The self-centering, curved-tip catheter has a greater separation between the arterial and venous tips compared to a symmetric-tip catheter. Its design is intended to optimize catheter patency, and to reduce fibrin sheath formation, thrombosis and vessel wall occlusions. This unique tip design keeps the tips of the catheter centered in the vessel and away from the vessel wall reducing vessel wall trauma.

An independent retrospective study1 conducted by a vascular access center showed 94.7% patency in the CentrosFLO catheter versus the competitor’s catheter, which had a patency rate of only 75% at 3 months. For more information about the CentrosFLO Long-Term Hemodialysis catheter, visit the CentrosFLO product web page.

  1 Balamuthusamy S. Self-centering, split-tip catheter has better patency than symmetric-tip tunneled hemodialysis catheter: single-center retrospective analysis. Semin Dial. 2014 Jan 20. Epub 2014 Jan 20

ReSolve® Non-Locking Drainage Catheter’s Smooth Transitions Help with One-Step Technique for Drainage

We have heard from many customers that the ReSolve Non-Locking Drainage Catheter (RNL) is great when using the one-step (direct puncture, trocar) technique when placing these catheters. The smooth transitions of the RNL help to insert the catheter smoothly through tissue without buckling, accordioning, or peeling back during insertion. Some of the drainage procedures that use the one-step technique include: abscess, paracentesis, thoracentesis, nephrostomy, and cyst.

Additional features:

  • Maximized drainage with large drainage holes
  • Decreased friction during placement with the hydrophilic coating
  • Maintain catheter patency via flexible material

To learn more, check out the ReSolve® Locking and Non-Locking Drainage Catheters product webpage.

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

PreludeEASE™ Hydrophilic Sheath Introducer Receives CE Mark

I’m pleased to announce that the PreludeEASE hydrophilic sheath introducer has received the CE mark and is now available for sale in Europe. The PreludeEASE hydrophilic sheath introducer has been designed with the performance you need to achieve radial access with ease.

PreludeEASEbannerV3

  • Hydrophilic coating can help reduce the incidence of arterial spasm during radial procedures.1
  • Coated to the tip of the sheath to facilitate easy insertion and removal.
  • Excellent transitions from dilator to wire and from sheath to dilator for smooth and easy insertion that can enhance patient comfort.
  • 4F-7F and 7, 11, 16, and 23 cm lengths for a variety of patient sizes and clinical needs.
  • Custom kit options
    • Merit Advance angiographic needle known for its sharpness and now with a bevel indicator
    • Spring coil, stainless steel, and nitinol mandrel guide wire options

PreludeEASE hydrophilic sheath introducers are a great complement to our growing line of products designed to support radial access procedures from start to finish.

To learn how you can achieve radial access with ease, contact a Merit Medical Sales Representative.

Stephanie Poulsen
Senior Product Manager

PreludeEASE is not 510(k) cleared for sale in the United States.

Merit Medical EMEA Launches Website

MAASTRICHT, The Netherlands— Merit Medical EMEA today launched its new website, www.MeritEMEA.com.

The new website is a key component of the company’s vision to be the most customer-focused company in healthcare. The eye-catching, user-friendly site was built with Merit Medical’s customers in mind, prominently featuring the company’s diverse range of products. In addition, www.MeritEMEA.com provides healthcare professionals the opportunity to share their first-hand experiences with Merit Medical’s products.

“To be the most customer-focused company in healthcare, we must listen to our customers and value their feedback,” said Justin Lampropoulos, Merit Medical EMEA’s Executive Vice President. “Our new website provides an easy way for our healthcare partners to tell us what they like and dislike about our products. Their input is invaluable to us to innovate and deliver high-quality products that triumph the toughest clinical challenges and improve lives.”

The new EMEA website also highlights the “Think Radial. Discover Merit.” and “Think Embolics. Discover Merit.” campaigns and their integrated product portfolios. Additional www.MeritEMEA.com features include the ability to request a visit from a Merit Sales Rep, customer service phone numbers for the more than 16 countries within Merit Medical EMEA’s boundaries, and the company’s latest news and history.

ABOUT MERIT MEDICAL SYSTEMS, Inc. 

Merit Medical Systems, Inc. (NASDAQ: MMSI), has been designing, manufacturing and marketing single-use medical devices for more than 25 years and serves client hospitals worldwide with a domestic and international sales force totaling approximately 200 individuals. Merit Medical Systems employs approximately 3,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Maastricht and Venlo, the Netherlands; Paris, France; Galway, Ireland; Beijing, China; and Rockland, Massachusetts.

Safeguard® Pressure Assisted Device: Trusted Femoral Performance Now Available for Radial Procedures

Many of our customers use the Safeguard Pressure Assisted Device for hemostasis following femoral access procedures because they trust its compression, convenience and comfort. Merit Medical now has the Safeguard Radial™ compression device that offers the same trusted compression after radial procedures.

COMPRESSION 
safeguard

  • The Safeguard Radial’s inflatable bulb focuses compression only where you want it
  • It’s easy to adjust air in the bulb (inflation or deflation) using a standard Luer lock syringe
  • Trusted Compression, Comfort & Convenience
  • Now Available For Your Radial Procedures
  • The base plate and the way the band wraps around the bulb provides stable positioning, not occlusion
  • You already know how important patent hemostasis is for a radial compression device and the Safeguard Radial allows you to achieve patent hemostasis with patient comfort as well

CONVENIENCE 

  • While your patients come in many sizes, Safeguard Radial comes in one size that will fit them all
  • Having one compression device can reduce your inventory, maximize your precious storage space, and streamline ordering
  • You can use any syringe because Safeguard Radial has a standard Luer lock
  • The inflatable bulb lets you take distal and proximal pulses easily
  • The visibility of the clear bulb window allows you to check for oozing

COMFORT 

  • Just like the Safeguard femoral, Safeguard Radial has a soft textile band with no plastic edges and a low profile design

So if you have been using the Safeguard for hemostasis following your femoral procedures, you can trust the Safeguard Radial to provide the same comfortable, convenient performance for radial compression.

Schedule an evaluation of the Safeguard Radial

Stephanie Poulsen
Senior Product Manager

Merit Medical Opens New Office in Tsim Sha Tsui, Kowloon, Hong Kong

Merit Medical Systems is pleased to announce the grand opening of a new office in Tsim Sha Tsui, Kowloon, Hong Kong. Merit Asia has been operating in Hong Kong for three years, and this larger office will help support our growing business with distributors in Hong Kong, Taiwan, and South East Asia.Joe Wright, President of Merit Technology Group was on hand to help with the ribbon cutting ceremony on June 12. Also pictured are Leon Lam, Vice President-Asia and Jo Choi, Regional Business Director for Hong Kong, Taiwan, and Southeast Asia.
image2-16
Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures in several disciplines including cardiology, radiology, nephrology, vascular surgery, electrophysiology, and endoscopy. Our broad product portfolio includes therapeutic products for dialysis, embolization of uterine fibroids and tumors, and strictures of the airway.
Merit Medical’s new Hong Kong address is:
Room 901B, 9/F, Empire Centre
68 Mody Road, Tsim Sha Tsui
Kowloon, Hong Kong
Phone: +852 2628 3612 Fax: +852 2628 3130
歡迎 and 祝你好運 !

ReSolve® Biliary Locking Drainage Catheter Receives CE Mark!

resolvebiliary-new

I am pleased to announce that the ReSolve® Biliary Locking Drainage Catheter has received the CE mark and is available for sale in Europe.

These catheters are indicated for drainage of bile within the biliary system. Often biliary systems need to be decompressed due to bile duct stones, extrahepatic, or intrahepatic tumors, and primary sclerosing cholangitis, among other reasons. In addition bile may also need to be diverted from a bile duct leak.

Biliary system lesions do not always occur in the same location in every patient. Because of this, Merit offers catheters with two different drainage hole configurations to accommodate patient anatomy and multiple disease locations.

Correct catheter positioning is important in these procedures. The catheter features a radiopaque marker band near the proximal shaft drainage hole, and non-radiopaque depth markers the entire length of the catheter to help with fast and accurate positioning.

Additional features:

  • Atraumatic pigtail
  • Smooth transitions
  • Large drainage holes
  • Hydrophilic coating
  • Kink resistance

To learn more, check out the  ReSolve® Biliary Locking Drainage Catheter product webpage.

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Merit Medical Hosts Medical Education Course on LV Implantation Techniques

Merit Medical hosted a course on LV Lead Implantation Techniques May 4-5. The course was conducted by Seth J. Worley, MD, Director of the Interventional Implant Program at Lancaster General Hospital in Lancaster, Pennsylvania. Dr. Worley is an internationally recognized expert and key opinion leader in the advancement of cardiac resynchronization therapy.

Dr. Worley presented unique approaches to LV lead implantation and techniques designed to help reduce procedure and fluoroscopy time, reduce lead failure rates, and improve lead location.1

In addition to the hands-on training with the unique tools and techniques, Dr. Worley also used the tools in two live cases in which he was able to demonstrate successfully this specialized approach. Each of the eight physicians on hand were able to learn interactively as he described each of the steps in the procedure to the audience through a live video feed and to the physicians who joined him in the procedure room.

When used together, the Worley Advanced System provides the tools and solutions needed to reduce implantation times, gain easier access to the target vessel, and improve chances for successful CRT implantation.1

Worley™ Advanced CSG

Worley™ Advanced LVI

Worley™ Vein Selector

For more information or to register for the next Worley training course, contact your local Merit Medical Sales Representative or visit merit.com.

Nelson Gardner
Business Development Manager

1 Jackson KP, Hegland DD, Frazier-Mills C, Piccini JP, Koontz JI, Atwater BD, Daubert JP, Worley SJ. Impact of using a telescoping-support catheter system for left ventricular lead placement on implant success and procedure time of cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2013 May; 36(5):553-8.

SCAI 2014 Attendees Get Hands On with Merit Medical’s Radial-Specific Products

Attendees were offered hands-on demonstrations of our radial products at the Society for Cardiovascular Angiography and Interventions (SCAI) meeting last week in Las Vegas. We exhibited several products supporting transradial access–the Rad Board® radial arm board and accessories, radial catheters, and the Safeguard Radial™ radial closure device–that generated lots of interest at the booth.

STREAMLINE SET UP FOR RADIAL PROCEDURES
With dedicated, radial-specific arm boards and accessories, cath lab personnel don’t need to use towels to obtain correct arm positioning. The reusable Rad Board fits all cath lab and radiology procedure tables. Visitors at the booth were surprised to learn that there is a section of Xenolite TB embedded in the Rad Board that helps to reduce scatter radiation exposure. See Radiation Scatter Survey Results.

RADIAL-SPECIFIC CATHETERS
We had a vascular model that attendees could use for a hands-on demonstration of our Performa Ultimate™ line of catheters. Merit also has the MIV™ radial ventriculogram pigtail catheter that is designed to angle toward the left coronary cusp to facilitate transradial access.

HEMOSTASIS OF THE RADIAL ARTERY
We demonstrated the Safeguard Radial pressure assisted device by putting it on some attendees. As a result, they learned firsthand how comfortable and convenient it is to get adjustable compression of the radial puncture site.

Attendees at SCAI this year were excited to learn about Merit’s new Think Radial training courses and enjoyed the hands-on demonstrations of our radial-specific products. For more information on our radial product portfolio or upcoming training courses, Contact Us.

Chan Ream
Product Manager

Merit Medical To Exhibit at PICS-AICS 2014 Chicago Symposium

For 16 years, Merit Medical has participated as an exhibitor at the Pediatric and Adult Interventional Cardiac Symposium (PICS-AICS). This year, the symposium will be held at the Marriott Chicago Downtown, June 7-10, 2014.

Merit Medical is committed to supplying purpose-built pediatric products for diagnostic and interventional medicine, particularly for interventional cardiology.

  • The Merit Diagnostic Cardiology FEP Catheter line includes a 3F Pediatric Pigtail Catheter.
  • The Merit Pediatric Judkins Right and Judkins Left Catheters are available with shapes as small as JR 1.5 and JL 1.5.
  • Merit also provides Pediatric Vessel Sizing Catheters.

New to our pediatric product line this year are:

We would like to invite you to stop by Booth 311 to view these products and many others offered by Merit Medical for the Pediatric and Adult Interventional Cardiologist.

For more information about Merit’s pediatric products, Contact Us.

Tami Anderson
Senior Product Manager

Safeguard® and Ergonomics in the Cath Lab

I recently read an article by Marsha Holton, CCRN, RCIS, FSICP, “An Ergonomic Survey of Cath Lab Repetitive Stress Injuries,” who observed that the duration of manual compression may be one of the ergonomic risk factors for cath lab repetitive stress injuries.

“Survey results regarding recovering access sites were surprising, particularly the mean holding pressure time of 19 minutes*. We may have identified at least one task that could increase the risk of carpal tunnel injury to our health care workers. Three of the seven ergonomic risks are involved in holding manual pressure. These are the risks of position and pressure, force, and duration, which may explain the trembling of those hands that held for 19 minutes.” [* Emphasis added]

safeguard
As a result of her survey, Ms. Holton encourages cath lab professionals to look for ways to reduce the risk of injury.

“If there is even a possibility that such injuries are caused by our work, it is important to identify what is hurting cath lab professionals, and what we can do to decrease the number of future injuries.”

For those who are looking for ways to reduce the duration of manual compression, I recommend using the Safeguard Pressure Assisted device. The Safeguard Manual Assist (SMAT) study—a multicenter trial of over 100 patients found that the device was effective in reducing active compression time.

  • The mean active compression time for all patients (n = 100): 7.7±3.3 minutes
  • The mean active compression time for diagnostic patients (n = 72): 6.6±2.9 minutes
  • The mean active compression time for interventional patients (n = 28): 10.5±2.5 minutes

Safeguard is indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures and it is effective in obtaining and maintaining hemostasis. It has a clear polyurethane window and bladder with adhesive backing and a Luer valve for inflation with a syringe to provide pressure to the puncture site.

Testimonials from two of the nurses who participated in the SMAT study support the effectiveness and comfort of the device:

“Well, I love this product because my hand doesn’t hurt when I go home at night.” —Karen Cronin, RN

“Safeguard is just a great thing for nurses and a great thing for the patients.” —Judy Champion, RN

To learn more about the Safeguard Manual Assist Technique, contact your local Merit Medical Sales Representative.

Mark Heninger
Senior Product Manager

Merit Medical Offers PD Kit for Interventional Radiologists

Introducing the NEW Merit Percutaneous Implantation Kit for peritoneal dialysis (PD) catheter placement. The kit is designed to accommodate stylette or over-the-wire placement using ultrasound guided access and fluoroscopy. At the recent Society of Interventional Radiology (SIR) meeting in San Diego, physicians were thrilled to learn about this procedure and the advantages of the Merit percutaneous kit over the competitor’s kit. This percutaneous kit is unique because it has a number of components not currently offered in competitive kits. These unique features include:

image1-15
  • 18G echogenic needle
  • Two Dilators: 12F and 14F for serial dilation
  • Cuff Implantor: Designed to simplify implanting the cuff through a smaller incision
  • 0.038″ x 150 cm Wire: Long enough to place the catheter over the wire
  • Tunneler: Specifically designed to match the O.D. of our catheter and sized for a small, tight exit site

Each Merit PD catheter, sold separately from the implantation kit, includes a sterile implantation stencil to promote placement accuracy and better PD catheter outcomes.

Product configurations: VP-511 (Includes plastic Faller Trocar) and VP-511M (Includes metal Faller Trocar)

In addition to these kits, Merit offers a number of interventional tools to assist in these procedures such as the Merit Laureate® hydrophilic guide wire and MAK-NV™ non-vascular micro puncture sets.

To learn more about these kits, visit our PD product web page or contact your local Merit Sales Representative.

Lynette Ruppel
Senior Product Manager

The Importance of Having Options for Foreign Body Manipulation and Retrieval

A survey conducted by Merit Medical found that radiologists, cardiologists, and vascular surgeons use, on average, two or more different endovascular snare devices in their practice. These physicians understand the importance of having options when a foreign object such as an IVC filter, stent, balloon fragment, broken catheter tip, or guide wire tip needs to be retrieved from the vasculature.

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Merit Medical recognizes this need and is pleased to be the only provider of two snare systems: an interlaced triple loop device–the EN Snare® Endovascular Snare System, and a single loop snare device–the ONE Snare® Endovascular Snare System. The EN Snare® and the ONE Snare® go hand-in-hand to provide physicians with the necessary options they need to meet any clinically-challenging case that may arise.

Check out our website to learn more about the suite of Merit Endovascular Snare Systems.

Jesse Hansen
Director of Marketing – Interventional Radiology

Retrospective Analysis Study Shows CentrosFLO® Long-Term Hemodialysis Catheter Tip Design Offers Greater Patency

centrocaths

The Merit Medical CentrosFLO long-term hemodialysis catheter’s self-centering split-tip design has a greater separation between the arterial and venous tips than the symmetric-tip designed catheter. Its design is intended to optimize catheter patency and reduce fibrin sheath formation, thrombosis and vessel wall occlusions by keeping the tips of the catheter centered in the vessel and away from the vessel wall.

In May of 2013, a retrospective study was completed by Dr. Saravanan Balamuthusamy (“Dr. Bala”) at Angiocare, Vascular and Interventional Nephrology, in Tucson, Arizona. The performance and safety of a new self-centering, split tip hemodialysis tunneled catheter was compared with a symmetric-tip catheter in 58 patients.

Study Conclusion1
The study results indicated that the CentrosFLO self-centering, split-tip catheter had statistically greater patency after 3 months with similar clearance and blood flow.

Self-Centering,
Split-Tip Design
(n = 38)
Symmetric-Tip
Design
(n = 20)
Statistical
Probability
Patency 94.7% 75.0% P = 0.04
Mean Clearance (Kt/V)2 1.483 1.423 NSD4 (p = 0.48)
Mean Blood Flow (ml/min)2 393.93 381.63 NSD4 (p = 0.27)

1 Study data on file.
2 Mean value during the three-month follow-up period.
3 Mean clearance and mean blood flow did not include data from patients with no catheter patency.
4 NSD = Not Statistically Significant, p > 0.05 (t-tests).

For a full published version of this study, contact your local Merit Sales Representative.

Nate Smith – Senior Product Manager
Merit Medical Systems, Inc.

New! 7.5F ReSolve® Locking and Non-Locking Drainage Catheter

We are now pleased to offer the ReSolve® Locking and Non-Locking Drainage Catheters in 7.5F. These catheters are indicated for percutaneous drainage of fluid from body cavities. Some of the drainage procedures performed with these catheters are abscess, nephrostomy and cyst.

For many fluid collections, a 6.5F catheter is often too small to drain the fluid, but an 8.5F catheter is too large for the patient. These new catheters are great for those fluid collections and patients where an in-between catheter is needed.

These catheters continue to offer

  • Smooth transitions
  • Large drainage holes
  • Hydrophilic coating
  • Kink resistance

For more product information on Merit’s Drainage Products, visit http://www.merit.com/products/default.aspx?code=drainage.

Ask4UFE Website Revamped

ask4UFE.comFor more than a decade, the Ask4UFE patient education campaign has been an invaluable resource for the many women who suffer from symptomatic uterine fibroids. Our campaign has educated hundreds of women and empowered them to become more involved in the decision-making process for treating uterine fibroids. Our campaign provides women who suffer from fibroids with information on all the available treatment options.

We are more impassioned than ever to help raise the awareness level around fibroids and all available treatment options. The revamp of our website, ask4ufe.com, is a huge milestone for us and represents the rebirth of our awareness campaign.

Help us raise the awareness level about uterine fibroids and don’t forget to Ask4UFE!

Sincerely,
Your friends at Ask4UFE

Merit Medical to Showcase Radial Product Portfolio at ACC March 29-31 in Washington, D.C.

Merit Medical will be showcasing its radial product portfolio at the 63rd Annual ACC Scientific Session and Expo this year. The Radial Product Line includes:

Rad Board® Reusable Arm Board
Easy set up with radiation scatter protection*

Rad Rest® Arm Cushion
Comfortable ergonomic support for wrist and elbow

Prelude® Radial Sheath Introducers
Efficient access with smooth transitions

InQwire® Diagnostic Guide Wire
Excellent navigation with PTFE coating

Performa Ultimate™ Angiographic Catheter
4 shapes designed for the radial approach.

MIV™ Radial Ventriculogram Catheter
Designed to angle toward the left cusp of the ventricle, for easier insertion via radial approach

ConcierGE® Guiding Excellence Catheter
30% more kink resistance than the leading brands – facilitating radial interventions**

Safeguard Radial™ Compression Device
Achieve radial hemostasis effectively and safely
Hands-free adjustable pressure and clear view of the access site

Visit us at ACC Booth 1911 in Washington DC to learn more about Merit’s comprehensive line of products to support your transradial procedures.

* Data on file.
** Test results are based on 6F guide catheter comparison. Data on file.

Merit Medical Announces Launch of New Corporate Video

Merit Medical has released a new corporate video!

The video describes how the company began–with a stronger, safer syringe– and how it’s continued to deliver quality medical devices for over 25 years.

Merit’s ability to understand, innovate, and deliver has helped us become a global leader in the medical device industry.

With state-of-the-art manufacturing facilities and a global sales and distribution network, Merit Medical continues to provide the tools healthcare providers need to deliver the best possible care to their patients.

Monica Haines
Senior Marketing Communications Manager

Merit Medical’s Safeguard® Allows Parents to Hold Their Babies After Heart Surgery

I have a grandson that is 20 months old and who is in perpetual motion. If he’s awake, his inquiring mind has him looking, touching and listening to everything. Recently he injured his hand, pinching it in a door. It wasn’t serious, but all of a sudden he went from running around his playroom, to wanting to be held by his mother. It was as if it didn’t hurt if she was holding him.

In reflecting on this, I think of children who undergo a diagnostic or interventional cardiology procedure in the Pediatric Cath Lab, such as septal defects (ASDs or VSDs) or valve defects, such as pulmonary valve stenosis, among others. When the procedure is finished and they are in recovery, these young patients have the same desire to be held that my grandson exhibited. Merit Medical’s Safeguard Pressure Assisted Device gives children the ability to be held by their parents after heart surgery.

In an article in the November 2006 issue of Cath Lab Digest, Jill Dykstra, RN and Kathy Laird, RN with the Congenital Heart Institute at the Arnold Palmer Hospital for Children, in Orlando, Florida authored an article titled, Use of the Safeguard Pressure-Assisted Dressing for Patients Less than 15 kg Following Cardiac Catheterization. In it they stated: “…Prior to implementation of the Safeguard hemostasis device, methods for maintaining hemostasis included pressure dressings that did not allow for the parents to hold the infant…”

This 6-month study found that “…the Safeguard device does not restrict mobility and allows for parental contact immediately post-procedure.

The Safeguard gives clinical personnel a pressure assisted device that promotes hemostasis, decreases occurrences of re-bleeds, and most important, gives a child the comfort of being in the arms of a parent.

For more information regarding Safeguard and Merit’s comprehensive line of products for promoting hemostasis, visit merit.com.

Mark Heninger
Senior Product Manager

Merit Medical Opens Office in Bangalore, India

Merit Medical Systems is expanding with a new office in Bangalore, India.

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This new location will allow Merit to take advantage of the growing Indian healthcare market.
The key reason for opening an office to serve the Indian market is the large need that has been generated for our products over the last 3-5 years.

image2-18Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures in several disciplines including cardiology, radiology, nephrology, vascular surgery, electrophysiology, and endoscopy. Merit Medical has several therapeutic products to help clinicians treat patients suffering from uterine fibroids, tumors, end stage renal disease, strictures of the airway, and blood clots. Our therapeutic products include devices and accessories used to support the implantation of pacemakers and the treatment of irregular heartbeats.

Merit Medical Systems India Pvt Ltd is located at the following address:
206-207, HM Geneva House
14 Cunningham Road
Bangalore- 560052, INDIA
Phone: +91-80-41223378
Fax: 91-80-41223365

The office will be used for sales and marketing operations in the region.

Merit Medical EP Group Announces Launch of HeartSpan® Steerable Sheath Introducer

Merit Medical continues to add to its extensive line of products for Electrophysiology. The HeartSpan Steerable Sheath Introducer offers control, coverage and comfort for Electrophysiologists when navigating cardiac chambers. The 8.5F HeartSpan Steerable Sheath Introducer’s braided construction provides kink resistance and curve durability. The distal tapered tip creates a smooth transition from the dilator to sheath introducer to reduce trauma to the atrial septum.

image1-16CONTROL 

  • Softer, flexible tip
  • Smooth transition from dilator
  • Responsive curve deflection
  • Braided construction for kink resistance

COVERAGE 

  • Bidirectional (180-degree) deflection
  • Small curl (16.4 mm)
  • Medium curl (22.4 mm)
  • Large curl (36.0 mm)

COMFORT 

  • Ergonomic shape
  • Improved grip size

The HeartSpan line of products also includes the HeartSpan® Fixed Curve Braided Transseptal Sheath with braided steel shaft for excellent torqueability and the HeartSpan® Transseptal Needle designed to be exceptionally responsive with enhanced stiffness.

Our EP team is excited to introduce this new steerable sheath designed to help EPs extend their options.

Merit Medical to Host Educational Events at the Society of Interventional Radiology (SIR) Annual Meeting This Year

We have some amazing things going on this year at the annual Society of Interventional Radiology (SIR) meeting March 22-27th. In addition to our booth presence, we will host various educational events.

March 23rd – Peter Hathaway, MD will speak about his percutaneous PD catheter placement technique with hands-on demonstrations
March 24th – Clement Proust, MD will speak in the Merit booth about his radial approach for endovascular abdominal interventions
March 24th – Meet the Author symposium with Francisco Carnevale, MD, PhD on the latest techniques in embolization

If you plan to attend the meeting this year, please stop by our booth to RSVP about these events or to learn more about our products.

Hope to see you there!

Jesse Hansen
Director of Marketing – Interventional Radiology

Merit Medical’s ConcierGE® Has Better Kink Resistance and 1:1 Torque Than Leading Guiding Catheter Brands

THE BAR HAS BEEN RAISED by Merit Medical with the introduction of the Merit ConcierGE Guiding Excellence Catheter.

In an independent survey, approximately 40% on Interventional Cardiologists indicated that their current guiding catheter does not meet their needs for kink resistance.

Designed in 5F, 6F, 7F, and 8F, ConcierGE is the first guiding catheter designed with a higher level of guiding excellence.

Kink Resistance
kink-graph
The ConcierGE has approximately
30% more kink resistance*
than the leading brands, facilitating
the advancement and withdrawal of
interventional devices.
1:1 Torque
torque-graph
The ConcierGE test results prove
that it has better 1:1 torque
response** than the leading
brands, promoting quicker catheter
seating with less whipping.*

Each feature of the guiding catheter is designed to give you added confidence in difficult cases by optimizing clinical benefits without compromise during coronary angioplasty.

To learn more about how Merit has raised the bar for guiding catheter performance, read the ConcierGE Brochure or watch the ConcierGE Guiding Catheter product video.

Tami Anderson,
Senior Product Manager

Merit Medical To Exhibit Dialysis Product Line at American Society of Diagnostic and Interventional Nephrology (ASDIN) in Phoenix, AZ February 21-23, 2014

Merit Medical is exhibiting at the 10th American Society of Diagnostic and Interventional Nephrology in Phoenix, AZ to introduce attendees to its expanding line of Hemodialysis and Peritoneal Dialysis products. The Merit Medical dialysis product suite includes the following key products:

  • The CentrosFLO® Hemodialysis Catheter, invented by Dr. Stephen Ash, was shown in a recent retrospective study to have superior patency due to its self-centering, curved-tip catheter which is designed to reduce thrombosis and fibrin sheath formation.1
  • The ProGuide™ Hemodialysis Catheter is a step-tip with an appositional bump design intended to reduce arterial insufficiency by keeping the tip of the catheter from sucking up against vessel wall. The ProGuide is well known as an exchange catheter due to its easy, over the wire placement capability.
  • The Flex-Neck® line of Peritoneal Dialysis Catheters allow for up to 35% higher flow rates than other catheters currently on the US market. The Flex-Neck Classic and ARC shapes are designed to accommodate various tunneling techniques and exit site options. Our unique Implantation Systems are designed to streamline your specific implantation technique.

Visit Merit Medical at Booth #303 to learn more about this broad line of products designed to enhance the practice of dialysis interventions and catheter placements.

Nathan Smith
Senior Product Manager

1Data on file

Merit Medical Supports Utah’s “STEM Curiosity Unleashed” Campaign to Promote Science, Technology, Engineering and Math Education

Merit Medical joined Governor Gary Herbert and other business leaders at a recent news conference to kick off the State’s “STEM Curiosity Unleashed” campaign.

image1-16

Merit and other Utah businesses donated $2.5 million dollars for an advertising campaign to encourage students to study and pursue careers in science, technology, engineering, and math.

The future of companies like Merit Medical depends on more people having a better understanding of science, technology, engineering and mathematics. We support STEM education because the future of our country depends upon it.

We are proud to participate in this effort to educate young people on the value of STEM education and the bright future that STEM careers offer.

image2-19

Merit Medical To Exhibit Dialysis Product Line at Annual Dialysis Conference (ADC) in Atlanta February 8-11, 2014

Merit Medical is exhibiting at the 34th Annual Dialysis Conference in Atlanta to introduce attendees to its expanding line of Peritoneal Dialysis and Hemodialysis products. The Merit Medical dialysis product suite includes:

  • PD Implantation Systems
  • PD Implantation Stencils
  • Flex-Neck® Classic and Flex-Neck ARC™ PD Catheters
    • Infant, Pediatric, Adolescent
    • Adult: Small, Medium, Large
  • Flex-Neck ExxTended™ PD Catheter for:
    • Upper Abdomen and Presternal Placements
  • Embedding® Tool
  • CentrosFLO® Hemodialysis Catheters
  • ProGuide™ Hemodialysis Catheters
  • Prelude® Short Sheath Introducers

Visit Merit Medical at Booth 116 to learn more about this broad line of products designed to enhance the practice of dialysis interventions and catheter placements.

Lynette Ruppel
Senior Product Manager

Merit Laureate® Hydrophilic Guide Wire Available In New 0.018″ Diameter

 

laureatehydrophillicguidewire

AVAILABLE IN NEW 0.018″ DIAMETER

I’m pleased to announce that Merit will be offering a 0.018″ diameter Merit Laureate Hydrophilic Guide Wire worldwide effective February 3, 2014. Smaller diameter guide wires are used in a number of different applications including standard arterial and venous angiography, PTA of chronic total occlusions, thrombolytic therapy, vena cava grams, and endovenous laser ablations.
The Merit Laureate is Merit Medical’s premier hydrophilic guide wire for the placement of devices during diagnostic and interventional procedures in radiology, cardiology, vascular surgery, nephrology, and urology.

THE MERIT LAUREATE OFFERS

  • True 1:1 torque control for greater turn-for-turn responsiveness and rapid vessel selection
  • Reliable and lasting lubricity to minimize surface friction for navigating highly tortuous anatomy and rapid catheter exchanges
  • Enhanced lesion crossability
  • Dependable visualization under fluoroscopy

Available now in 0.018″, 0.025″, 0.035″, and 0.038″ diameters, 80 cm to 260 cm lengths, standard and stiff body, with angled and straight tip configurations. Click here to watch our Merit Laureate Product Demonstration Video with side- by-side comparison to the market leader and a product feature animation.

PENNY GOLDMAN
Senior Product Manager

Merit Medical to Showcase HeartSpan® Product Portfolio at the AF Symposium Jan 9-11 in Orlando

Merit Medical will be showcasing its electrophysiology product line at the 19th International AF Symposium on atrial fibrillation in Orlando, Florida.

Visit us at Booth 501 for a hands-on demonstration of the new HeartSpan® Steerable Sheath. Attendees will be able to experience the comfort and control of the larger handle and its bidirectional articulation with a hands-on demonstration on a tabletop vascular model.

The HeartSpan line of products also includes the HeartSpan® Fixed Curve Braided Transseptal Sheath with braided steel shaft for excellent torqueability and the HeartSpan® Transseptal Needle designed to be exceptionally responsive with enhanced stiffness.

For comfortable, convenient hemostasis following your EP and CRM procedures, Merit offers the Safeguard® 24 cm Pressure Assisted Device designed for compression of femoral access sites.

Our EP team looks forward to meeting attendees and introducing them to Merit’s extensive line of products for advancing CRT Delivery and LV Lead Implantation.

Jon Jensen Senior Product Manager

Merit Medical Receives 510(k) Clearance for ASAPLP™ Low Profile Aspiration Catheter

I’m pleased to announce that we have received 510(k) clearance for the ASAPLP Low Profile Aspiration Catheter, a new low-profile addition to our ASAP® line of aspiration catheters. The ASAPLP received the CE mark on August 30.

asaplp

The ASAPLP is designed to remove fresh, soft emboli and thrombi from vessels of the arterial system.

QUICK ASPIRATION

  • Fits into 6F guide catheter of ≥0.066” with ease
  • A 4F catheter designed for maximum aspiration
  • Long 30 cm hydrophilic coating promoting deliverability
  • Longer 20 cm rapid exchange lumen designed for better wire trackability

EFFECTIVE

  • 100% stainless steel braided, kink resistant 145 cm low profile aspiration catheter
  • Improved tip radiopacity due to radiopaque platinum iridium marker band
  • Bright colored wire exchange lumen

OPTIONS

  • Packaged with stiffening stylet

ASAPLP is Merit Medical’s latest innovation for quick, effective aspiration! For more information on the ASAP line of aspiration catheters, see the the Aspiration Catheter Family Brochure.

Elizabeth Pratt
Senior Product Manager

Cynthia Bailey, The Real Housewives of Atlanta Cast Member, Will Undergo Uterine Fibroid Embolization on November 17 Episode

Cynthia Bailey revealed that she had fibroids in last week’s episode of the Real Housewives of Atlanta. Cynthia complained of heavy bleeding and long menstrual periods and the toll it was taking on her body and her personal life.

On the episode, set to air on Sunday, November 17 at 8 PM Eastern time, the cameras will be present when Cynthia undergoes a uterine fibroid embolization (UFE) procedure. Cynthia described the results of her UFE procedure in a recent interview as “life changing.” “Everything has changed and it has been amazing. I’m so glad I took care of it.” She said that she decided to share this experience to promote public awareness of uterine fibroids.

Uterine fibroids affect millions of women between the ages of 20 and 50 and are more common in African American women. Bailey hopes that fans will be inspired by her story.

Merit Medical sponsors an informational resource, the ask4UFE.com website, devoted to educating women about fibroids, treatment options, and UFE. The website includes a Physician Locator Tool to help women find physicians in their area who perform the UFE procedure.

ask4ufe logo

Merit Medical also offers embolization products that are used in uterine fibroid embolization (UFE) procedures: Embosphere® Microspheres and Bearing nsPVA™ nonspherical polyvinyl alcohol embolization particles. UFE is a less invasive treatment than hysterectomy. Go to http://www.ask4UFE.com today to determine if UFE is the right treatment option for you.

Merit Medical Exhibiting at 2013 AIM & VEITH Symposiums in New York, November 18-23, 2013

Merit Medical is proud to support AIM & VEITH, which will include educational sessions on the latest developments in interventional radiology, oncology, cardiology and vascular access.

We would like you to join us as we display our “Big Apple” welcome at AIM Booth 420 and VEITH Booth 110. Featured products will include:

We look forward to seeing you in New York City!

Patty Jabotte
Marketing Communications Manager

*Not currently available in the US  510(k) review pending

Merit Medical Adds 2 New Products for Assisting Hemostasis

safeguard

I’m excited about the recent announcement of Merit Medical’s acquisition of the Safeguard® products for assisting hemostasis. The Safeguard 12 cm and 24 cm Pressure Assisted Devices are latex-free, self-adhesive dressings designed to assist in obtaining and maintaining hemostasis. The 24-cm device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures with an ACT of 140 seconds or less, using a 6 F and smaller sheath size.

Safeguard Product Features

Ergonomic
•       Hands-free adjustable pressure of the puncture site
•       Inflatable bulb and standard Luer valve for easy inflation and deflation with any standard Luer syringe

Visibility
•       Clear window allows better visibility of the puncture site

Comfortable
•       Safeguard maintains a consistent pressure
•       87% of patients in a study indicated that Safeguard was “much more comfortable” than manual compression alone1

Secure
•       Adhesive provides a secure fit and minimizes movement or dislocation

Merit Medical’s growing portfolio of hemostasis products now includes the Safeguard, the Finale® and the RADstat® Radial Compression Devices and the Clo-Sur PLUS P.A.D.™ Antimicrobial Barrier.

Mark Heninger
Senior Product Manager

1 Roberts, A et al. Safeguard Manual Assist Technique: The SMAT Study. Cath Lab Digest, June 2008:38.

Merit Medical to Host Luncheon Symposium on Dialysis Techniques at CIDA 2013

Merit Medical is looking forward to attending the 2013 Controversies in Dialysis Access (CIDA) Meeting October 24-25 at the Westin St. Francis in San Francisco, California. Merit Medical will be hosting a luncheon symposium:
Dialysis Techniques and Clinical Outcomes
Moderator:
Stephen R. Ash, MD, Interventional Nephrologist, Ash Access Technology, Inc.
Speakers:
Saravanan Balamuthsamy, MD, Angiocare, Tucson, AZ
90 Day Patency Comparison: Self-Centering, Split-Tip Catheter vs Symmetric-Tip Catheter
Peter Hathaway, MD, Utah Vascular Clinic, Salt Lake City, UT
Peritoneal Dialysis – Percutaneous Case and Technique
Thursday, October 24,
12:00 PM-1:00 PM
California West Room
Merit Medical will also be sponsoring a Live Peritoneal Dialysis Catheter Placement Procedure by John Ross, MD, RMC Dialysis Access Institute, Orangeburg, South Carolina.
We hope you will join us for both the Luncheon Symposium.
Click on the links below to learn more about Merit Medical’s catheters and accessories for long-term hemodialysis and peritoneal dialysis including CentrosFLO® and ProGuide™ long-term hemodialysis catheters.
Chan Ream

Product Manager

Merit Medical Launches Embosphere® and HepaSphereTM Microspheres in Japan

I am pleased to announce that Nippon Kayaku (authorized distributor for Merit Medical Systems, Inc.) has received distribution and marketing authorization in Japan for Embosphere Microspheres and HepaSphere Microspheres.
The Japan Ministry of Health, Labour and Welfare held the “10th Investigative Commission about Expedited Introduction of Medical Devices, Which Are Strongly Needed in Medical Treatment” and it recommended the introduction of Embosphere and HepaSphere Microspheres to the Japan market. The recommendation was fulfilled by approval of both products in June 2013.
Embosphere Microspheres, the most clinically studied round embolic, provide consistent and predictable results for effective embolization in the treatment of uterine fibroids, hypervascular tumors, and arteriovenous malformations. Used worldwide in over 250,000 procedures since 2002, Embosphere Microspheres are the gold standard in uterine fibroid embolization, with Interventional Radiologists choosing Embosphere Microspheres in 73% of cases according to the FIBROID registry published in Obstetrics and Gynecology.
HepaSphere Microspheres are biocompatible, hydrophilic, nonresorbable, and conformable microspheres designed for controlled, targeted embolization. HepaSphere Microspheres also rapidly absorb aqueous solutions such as contrast media or saline. HepaSphere Microspheres enable physicians to optimize outcomes by more precisely matching the sphere size to the size of the targeted vasculature. In Japan, HepaSphere Microspheres are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in the following procedures:

  • Embolization of hepatocellular carcinoma
  • Embolization of metastases to the liver
Please visit our product pages for more information.
Noah Wong
Product Manager, Merit Medical

You Have Options For Treating Your Uterine Fibroids

Did you know that there are minimally-invasive treatment options available to treat uterine fibroids and the common symptoms associated with them: heavy bleeding, pelvic pain, and frequent urination?
In 2008, Uterine Fibroid Embolization (UFE) was recognized by the American College of Obstetricians and Gynecologists (ACOG) as an alternative to hysterectomy in the management of uterine fibroids.
      If you are not a good candidate for hysterectomy,
      If you want to avoid surgery for your fibroids,
      If you want to keep your uterus,
ASK ABOUT UFE!
UFE is a proven, effective option for treating uterine fibroids. To learn more about your options, go to www.ask4ufe.com.

Merit Medical Announces the Latest in Inflation Device Technology– the New basixTOUCH™

Merit Medical’s 35 ATM basixTOUCH Inflation Device is now available in the U.S., Europe, and many other countries around the world. The basixTOUCH is the latest innovation in inflation from Merit, and offers 35 ATM pressure capability as well as 30 mL of syringe volume to make it easier to accommodate a wide array of interventional balloons.

We surveyed hundreds of physicians and techs, and found a strong desire for a device that was easy on the hands, quick to set up, easy to inflate, and fast to deflate. From this feedback, Merit has designed a device with one-handed prep, an easy-to-turn quick-release handle.

basixtouch

The basixTOUCH expands your capacity with the innovation, quality, and reliability that Merit customers have enjoyed for over 25 years. To learn more about this new product and other products supporting interventional and diagnostic procedures, please contact your local Merit Sales Representative or visit us at www.merit.com.

Guido Sandulli
Director of Marketing, Interventional Cardiology

Merit Medical™ Endovascular Snare System Interactive iPad App Version 2.0 Now Available!

I am pleased to announce the availability of the Merit Medical Snare Interactive App version 2.0 for the iPad.

The app is designed to help you select the appropriate size EN Snare® or ONE Snare® to use in a desired vein or artery. The app is also designed to provide the technical product specifications for reference and ordering purposes.

DOWNLOAD the Merit Snare Interactive App for the iPad by clicking on the following link:
http://cloud.merit.com/apps/meritsnares/index.html

ADD THIS INTERACTIVE APP TO YOUR iPAD

  • Open the link in Safari
  • Select the menu option “Add to Home Screen ”
  • Once complete, close Safari
  • Access the app directly by tapping on the Merit Snares app icon

Merit Medical’s EN Snare and ONE Snare Endovascular Snares
Accuracy.Reliability.Options.

Jesse Hansen
Director of Marketing – Interventional Radiology

New! 7F Prelude® Sheath Introducers for Radial, Brachial, and Femoral Access from Merit Medical

Prelude 7F

I’m happy to announce the expansion of Merit Medical’s Prelude Radial Sheath Introducer product family. The 4F-6F product line now includes 7F sheaths for radial, brachial and femoral access. The new 7F sheaths are available in lengths of 7 cm, 11 cm and 23 cm; all kits include an 0.018” guide wire and 21G Merit Advance® angiographic needle.

The Prelude Sheath introducers provide excellent transitions for easy and smooth access to your patient. Custom kits including the sheaths can be designed to meet your specific needs.

Merit Medical is committed to providing excellent quality products for your access needs. To learn more about this new product and other products, please contact your local Merit Sales Representative or visit us at www.merit.com.

Stephanie Poulsen
Senior Product Manager, Merit Medical

Merit Medical Launches Bearing™ nsPVA (nonspherical polyvinyl alcohol)

We are pleased to introduce Bearing nsPVA Embolization Particles, the latest addition to Merit Medical’s broad array of interventional radiology embolization options.

bearingembopart

Merit Medical has been the market leader in spherical embolics (Embosphere® Microspheres) for over a decade and Bearing nsPVA will round out Merit’s embolization portfolio with an economical and nonspherical option. Merit’s established tradition for using state-of-the-art equipment and manufacturing processes has enabled us to develop this new product that offers enhancements over existing products in the current market.

Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters.

Bearing nsPVA is indicated for arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

We look forward to Bearing nsPVA leading the way to targeted embolization.

Noah Wong
Product Manager

Cath Lab Digest Article Shows How a Merit Medical Custom Fluid Management Set Up Can Help Reduce the Risk of Air Embolism

recent Cath Lab Digest article, “Proposal of Manifold Variation for Use During Cardiac Catheterization,” reported that a new manifold set up used in 1,500 diagnostic catheterizations was “safe, very easy and convenient to use.”

In the article, a custom Merit Medical Fluid Management Kit was pictured showing a modified construction that allows physicians to inject medication while keeping the system closed during angiography, thus reducing the risk of air embolism associated with syringe exchanges.

HowardFigure1
Photo of Merit Medical fluid management products in the configuration suggested in the article.

By inserting a 3-way stopcock with pigtail attached to a 5 mL syringe on the heparin flush line, the operator can inject medication through the heparin flush line into the arterial circulation without exchanging the syringe from the manifold.

Click on the following link to watch our Fluid Management System & Custom Designed Kits video. To find out how to get this custom fluid management kit, contact a Merit Medical Representative today!

Mark Heninger
Senior Product Manager

Merit Medical Receives CE Mark for HepaSphere™ Microspheres 30-60 Micron Size

I am pleased to share that we have received the CE Mark for HepaSphere Microspheres’ newly developed 30-60 micron size. The new smaller size provides physicians with the ability to achieve more distal occlusions when embolizing hypervascular tumors and arteriovenous malformations. When packaged in their dry state, the new size microspheres measure 30-60 microns, but when reconstituted for use, they expand to 120-240 microns.

Hepashpere

HepaSphere Microspheres are biocompatible, hydrophilic, non-resorbable, and conformable microspheres designed for controlled, targeted embolization. HepaSphere Microspheres also rapidly absorb aqueous solutions such as contrast media, saline, or doxorubicin HCI. HepaSphere Microspheres 30-60 micron size, along with the currently available sizes, further enable physicians to optimize outcomes by more precisely matching the sphere size to the size of the targeted vasculature.
I am delighted to bring this new smaller size to the market together with a broad line of Interventional Radiology implant options designed to help physicians offer the best possible patient care.

Jim Kelly
Senior Director of Marketing, Merit Medical

HepaSphere Microspheres are not approved or available for sale in the United States.

Merit Laureate® Hydrophilic Guide Wire Available in New 0.025” Diameter

I’m pleased to announce that Merit will be offering a 0.025” diameter Merit Laureate Hydrophilic Guide Wire worldwide effective June 24, 2013. Smaller diameter guide wires are used in a number of different applications including standard arterial and venous angiography, PTA of chronic total occlusions, thrombolytic therapy, vena cava grams, and endovenous laser ablations.

The Merit Laureate is Merit Medical’s premier hydrophilic guide wire for the placement of devices during diagnostic and interventional procedures in radiology, cardiology, vascular surgery, nephrology, and urology.

The Merit Laureate offers

  • True 1:1 torque control for greater turn-for-turn responsiveness and rapid vessel selection
  • Reliable and lasting lubricity to minimize surface friction for navigating highly tortuous anatomy and rapid catheter exchanges
  • Enhanced lesion crossability
  • Dependable visualization under fluoroscopy

Available now in 0.025”, 0.035”, and 0.038” diameters, 80 cm to 260 cm lengths, standard and stiff body, with angled and straight tip configurations. Click here to watch our Merit Laureate Product Demonstration Video with side-by-side comparison to the market leader and a product feature animation.

Penny Goldman
Senior Product Manager

Merit Medical’s Valved One-Step™ Centesis Catheter Is Designed to Reduce Pneumothorax

Pneumothorax is a common complication resulting from a thoracentesis procedure. The pneumothorax may be caused by the needle puncturing the lung, or by air entering the pleural space from the needle or catheter. To reduce the risk of air entering the pleural space via the catheter, the Valved One-Step Centesis Catheter has a valve in the catheter hub.

The valve closes immediately upon removal of the needle. In the closed position, air is unable to enter the catheter as the patient breathes and thus reduces the chance of pneumothorax by air entering the pleural space via the catheter.

Visit the Merit Medical website to learn more about the Valved One-Step Centesis catheter.

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Depth Markers on Merit Medical’s ReSolve® Locking Drainage Catheter Help Ensure Safe and Accurate Placement

In a survey of Radiologists and Interventional Radiologists, roughly 80% said they measure the depth from the skin to the fluid collection prior to inserting a drainage catheter. Various reasons were given for this practice including “accuracy and safety”. To help ensure safe and accurate placement of the ReSolve Locking Drainage Catheter, depth markers are placed the entire length of the catheter beginning 1 cm proximal to the distal tip.

To help with accurate placement, some physicians mark the depth on their catheter. Having the marks pre-printed on the catheter will reduce the need for physicians to mark the catheter, potentially saving time with more accuracy.

Visit the Merit Medical website to learn more about the ReSolve Locking Drainage Catheter.

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Merit Medical to Showcase the New basixTOUCH™ Inflation Device at EuroPCR May 21-24, 2013

Merit Medical continues to lead the world in inflation device technology with its latest innovation – the basixTOUCH Inflation Device*. We are pleased to showcase the basixTOUCH and several other innovative products and accessories at EuroPCR in Paris next week.

The basixTOUCH delivers

  • 30 mL Fluid Capacity
  • 35 atm Pressure Capability
  • Fast, Efficient Inflation and Deflation
  • Ergonomic Handle
  • One-Handed Prep and Priming
  • Durable Construction
  • Reliable Performance

Please join us at Booth M64 to learn how the basixTOUCH can help to “Expand Your Capacity” and why “It’s All In The Touch.”

To see Merit Medical’s entire portfolio of cardiology products, visit our website – www.merit.com.

Guido Sandulli
Director, Cardiology Group

* Pending FDA 510(k) review

Merit Medical Exhibiting at WCIO Show in New York, May 16-18, 2013

The World Conference on Interventional Oncology (WCIO) 2013 Meeting will take place at the New York Hilton Midtown Hotel. WCIO will feature innovative Interventional Oncology (IO) experts, discussions on current IO topics, unique live case presentations, and the latest scientific advances. 

Please stop by and visit Merit Medical at Booth 18.

Featured products will include:

Experience a new era in hydrophilic guide wires with the Merit Laureate 
Hydrophilic Guide Wire hands-on discovery model. Try it out and you’ll see for yourself the true meaning of 1-1 torque as the guide wire is manipulated through tortuous anatomy in a vascular model.

We look forward to seeing you at the show!

Patty Jabotte
Marketing Communications Manager

Merit Medical Introduces ClassicSheath™ – The Gold Standard in EP Vessel Access – at HRS Meeting in Denver

Discover why Merit Medical’s ClassicSheath Splittable Hemostatic Introducer System is the gold standard for EP vessel access at the upcoming Heart Rhythm Society meeting in Denver, Colorado May 8-10.

Merit is proud to officially introduce

  • ClassicSheath
  • LV Delivery System
  • HeartSpan® Transseptal Needle
  • HeartSpan Transseptal Sheath

as part of Merit’s new extensive EP vessel access line. Also to be featured at the Merit booth are the new ONE Snare™ Single Loop Endovascular Snare System and the Impress® Vein Selector Catheter.

Visit us at Booth 549 for exciting hands-on demonstrations of these products and more.

Clint Poulsen
Marketing Communications Manager

Merit Medical’s New MIV™ Radial Ventriculogram Pigtail Catheter is Designed for the Radial Approach

Merit Medical announces the release of its MIV Radial Ventriculogram Catheters. This pigtail catheter is designed to angle toward the left cusp from the radial approach, facilitating easier insertion into the ventricle.

Advantages of the MIV Pigtail include:

  • Catheter is angled toward the left cusp facilitating insertion into the ventricle
  • Faster access
  • Reduced fluoroscopy time
  • Reduced procedure time
  • Decreased catheter manipulation

The catheter is available in two tip lengths (short and long) and is available in 4F, 5F, and 6F with lengths of 110 cm and 125 cm. To learn more about this new design, contact your local Merit Sales Representative or visit us at www.merit.com.

Tami Anderson
Sr. Product Manager

Experience Merit Laureate’s 1:1 Torque Firsthand at the Merit Discovery Station at SIR 2013

Discover a new era in hydrophilic guide wires at the 2013 Society of Interventional Radiology (SIR) meeting in New Orleans April 13-18. Merit’s Laureate Discovery Hands-On Demonstration Models allow the clinician to experience the real meaning of true 1:1 torque as guide wires are manipulated through tortuous anatomy in a vascular model.

While attending SIR this year, please stop by Merit’s booth #1831, and familiarize yourself with the Laureate Hydrophilic Guide Wire to experience unparalleled torque control at your fingertips.

Watch the Merit Laureate product video to view an actual torque demonstration with the competition. See the new Merit Laureate brochure.

Penny Goldman
Senior Guide Wire
Product Manager

Practice Makes Perfect! Hands-On Demo of Merit’s Endovascular Snare Systems at SIR 2013

Merit Medical will showcase two endovascular snare systems at the 2013 Society of Interventional Radiology (SIR) meeting in New Orleans:

A new hands-on simulation model will be on display in the Merit booth to give physicians the opportunity to practice the retrieval of foreign bodies and to build confidence with both the EN Snare and ONE Snare. The physician feedback about the hands-on experience from prior shows has been very positive and energetic.

If you plan to attend SIR this year (April 13-18), stop by and check out the hands-on simulation model for yourself. Hope to see you there!

Jesse Hansen
Marketing Director – Radiology

Merit Medical’s Worley™ LV Delivery System Highlighted at Implantable Cardioverter Defibrillator (ICD) Course

Merit Medical proudly displayed our broad product offering and the newly acquired Thomas Medical products at the Fourth Annual ICD, CRT Implantation, Programming, Troubleshooting, and Extraction course held at the University of San Diego, February 22-24. Highlighted products included the ClassicSheath™ Splittable Hemostatic Introducer SystemONE Snare™ Endovascular Snare System, Merit Laureate® Hydrophilic Guide WireSeaDragon™ Guide Wire Torque Device, and the Worley LV Delivery System.

Seth J. Worley, M.D., a world-renowned expert in advanced CRT implantation technique, demonstrated in an anatomical model how the Worley LV Delivery System and ONE Snare Endovascular Snare System are used with his unique advanced techniques. During each break, large groups of physicians gathered around the Merit booth to watch Dr. Worley in action.

A lot of interest was generated in our product offering and it was a great way to say “Hello” to the Electrophysiology community. Merit Medical Systems clearly showed that it is committed to providing innovative solutions to enhance and improve patient care.

Matt Toone
Marketing Director, Electrophysiology

Merit Medical Exhibiting at SIR Show in New Orleans April 13-18, 2013

New Orleans, LA is one of the world’s most fascinating cities. Steeped in history, it is home to a truly unique melting pot of culture, food, and music. It is also the site for the Society of Interventional Radiology (SIR) 2013 annual meeting. SIR will include education on the latest developments in interventional oncology and peripheral vascular, venous, and neurovascular disease.

We would like you to join us as we display our “Big Easy” charm at Booth 1831. Featured products include:

Experience our hands-on product demonstration models to learn more about the Merit Laureate and ONE Snare products.

Tami Anderson
Senior Product Manager

Merit Medical’s Angiographic Needles Are An Important Start To Any Procedure

The start of any angiographic procedure is as important as the outcome. Merit Medical is looking forward to demonstrating the advantages of its broad line of angiographic needles at the Access, Closure & Safety station at the Merit Medical booth at SIR 2013 in New Orleans, April 13-18. Our curved needles will be included in the Dialysis Products station.

Gaining access to a patient is critical for the best procedure outcome. As a leading provider of angiographic introducer needles, it is our goal to provide you the needle options you need for any angiographic or dialysis procedure.

  • Standard One Wall Needles
  • Safety Needles
  • Curved Needles For Specialized Dialysis Procedures

The Merit Advance® Angiographic Needle, Majestik® Angiographic Needle, and SecureLoc® Angiographic Needle are designed with

  • Unique Ergonomic Hubs
  • Increased Sharpness
  • Smooth Guide Wire Insertion And Removal

We hope you will visit our booth at SIR or visit our website, www.merit.com, to learn more about Merit’s full line of high-performance angiographic needles.

Chan Ream
Product Manager
Merit Medical

Merit Laureate® Hydrophilic Guide Wire Available in New 0.038” Diameter

I’m pleased to announce that we will be offering a 0.038” diameter Merit Laureate Hydrophilic Guide Wire worldwide. The increased diameter size will provide additional support options for physicians. Additional support is often required for very tortuous vasculature or when devices requiring additional support are used during procedures.

The Merit Laureate is Merit Medical’s premier hydrophilic guide wire for the placement of devices during diagnostic and interventional procedures in radiology, cardiology, vascular surgery, nephrology, and urology.

The Merit Laureate offers

  • True 1:1 torque control for greater turn-for-turn responsiveness and rapid vessel selection
  • Reliable and lasting lubricity to minimize surface friction for navigating highly tortuous anatomy and rapid catheter exchanges
  • Enhanced lesion crossability
  • Dependable visualization under fluoroscopy

Available in 0.035” to 0.038” diameters, 80 cm to 260 cm lengths, standard and stiff body, with angled and straight tip configurations. Click here to watch our Merit Laureate Product Demonstration Video with side-by-side comparison to the market leader and a product feature animation.

Penny Goldman
Senior Product Manager

Merit Laureate® Hydrophilic Guide Wire Demonstration and QuadraSphere® 30-60 µm Microspheres Generate Interest at the 2013 CIO Meeting in Miami

Merit Medical’s booth was a frequently visited destination at the 2013 Symposium on Clinical Interventional Oncology (CIO), January 18-19 at the Fontainebleau Hotel in Miami Beach.

The anatomical discovery model allowed attendees to see and feel firsthand the exceptional torque control and turn-by-turn responsiveness of the Merit Laureate Hydrophilic Guide Wire. Attendees also showed a lot of interest in QuadraSphere 30-60 µm Microspheres, Embosphere® Microspheres, Merit Maestro® Microcatheter, H2O Torq™ Torque Device, and the SeaDragon™ Guide Wire Torque Device.

Merit Medical supported a CME Session: ADVANCES IN DRUG-ELUTING EMBOLICS FOR CHEMOEMBOLIZATION presented by Dr. Katarina Malagari from the National University of Athens, in Athens, Greece.

Merit Medical had a great show and is looking forward to continuing to provide product innovations and accessories designed to enhance the practice of interventional radiology and oncology.

Patty Jabotte
Marketing Communications Manager

Smaller Packaging for Merit Medical’s ASAP® Aspiration Catheter

Merit Medical recognizes that busy cardiac catheterization and interventional radiology labs need to maximize shelf space for their inventory. The ASAP Aspiration Catheter’s new, smaller box will be available worldwide by the end of January 2013. The new 10” x 11” size box will take up less space, which is valuable to any healthcare organization, especially in clinical areas.

Inside the new packaging is a thermoform tray that securely contains the following components:

  • ASAP Aspiration Catheter
  • 21.5 cm Tubing Set With Stopcock
  • (2) 30 mL Merit VacLok® Vacuum Pressure Syringes
  • (2) 70 µm Filter Baskets
  • (1) 4 mL RXP® Rapid Exchange Prep Syringe
  • MicroStop™ Closed Waste Basin & Lid

The ASAP Aspiration Catheter is designed to remove soft emboli or thrombi from vessels in coronary and peripheral vasculature. We hope our customers like the new, smaller size packaging!

Elizabeth Pratt
Senior Product Manager

Top 10 Merit Medical Product Videos for 2012

Top ten lists are a great way to learn what’s on people’s minds, and at Merit Medical, we learned a lot by reviewing the top ten most-watched product videos in 2012.

Over 24,000 viewers took interest in Embosphere® and HepaSphere™–our microsphere embolization products. 23,000 watched videos for ProGuide™ Chronic Dialysis Catheters. Rounding out the top ten were the EN Snare® Endovascular Snare System, the ASAP® Aspiration Catheter, and the ReSolve® line of drainage catheters. There were over 3,000 views of the Great Product, Great People, Great Company video about Merit Medical Systems facilities and capabilities.

We hope viewers will continue to watch our videos or visit our website, www.merit.com, to see even more product videos that will be released in 2013.

Merit Medical to Exhibit Interventional Vascular Products at ISET January 20-23, 2013 in Miami Beach

Merit Medical is proud to help celebrate the International Symposium on Endovascular Therapy’s 25th anniversary in Miami Beach, Florida. Merit will exhibit with a 10 x 10 booth from January 20-23, 2013 at the Fontainebleau Hotel (Booth # 102). Exciting hands-on opportunities will be presented at the Merit Medical booth for several new products including the ONE Snare™ Single Loop Endovascular Snare System and the BowTie™ Guide Wire Insertion Device. Also making a splash will be the Merit Laureate® Hydrophilic Guide Wire where a life-like vascular model will be available to experience the rapid vessel selection and true one-to-one torque. Other products that will be featured are: Embosphere® Microspheres, QuadraSphere® Microspheres, Blue Diamond™ Digital Inflation Device and the Merit Maestro® Microcatheter. Please join Merit Medical at the ISET opening reception on Sunday night 7-9 P.M., January 20th, for refreshments.

Merit Medical to Exhibit Its Line of Cardiology Products at PICS/AICS January 19-22, 2013

Merit Medical will be exhibiting at the 2013 Pediatric & Adult Interventional Cardiac Symposium at the Loews Hotel in Miami Beach, Florida on January 19-22. Merit will be displaying its extensive line of cardiology products at Booth # 17. Please visit us to experience hands-on product interactions and to see our wide variety of Performa® Diagnostic Cardiology Catheter shapes, our impressive line of Prelude® Sheath Introducers, as well as our newest additions to the cardiology portfolio: the Blue Diamond™ Digital Inflation Device and the ONE Snare™ Single Loop Endovascular Snare System. We look forward to seeing you at the Merit Medical booth in January.

ReSolve® Locking Drainage Catheter

I am extremely happy to announce two new improvements to our ReSolve® Locking Drainage Catheter.

1. The tip of the catheter will be positioned within the pigtail curl to minimize tissue irritation that may be caused by the catheter tip.

2. Non-radiopaque depth markers have been added to the catheter shaft to aid in placing the catheter.

The non-radiopaque depth markers will be helpful for clinicians using the trocar technique for placement into fluid collections such as abscess, nephrostomy and cysts. Clinicians will be able to use the depth markers as a guide for determining where the catheter is in relation to the fluid collection during placement.

After placement, the non-radiopaque depth markers may be used by patients and caregivers as a reference for the correct depth positioning of the catheter.

The catheters are available in 15 cm, 25 cm and 40 cm lengths to facilitate catheter placement using different imaging modalities and fluid collections of varying depths.

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Merit Medical 2012: A Year of Accomplishments

As the year comes to a close, I am looking back on 2012 and realizing what an amazing year it has been for Merit Medical. Here are a few of our accomplishments in 2012:

Positive Sales Growth
2012 not only marked Merit’s 25th anniversary, but also 25 straight years of positive sales growth. This is impressive considering how much the struggling economy has impacted many medical device companies in our space. We’re very proud of that.

New Products
The company continues to launch new products, which it has done every year since its founding in 1987. In 2012 we introduced the Blue Diamond™ digital inflation device, the BowTie™ guide wire insertion device, the EndoMAXX® fully covered esophageal stent, and the ONE Snare™ endovascular snare system. We also received 510(k) clearance from the FDA to market the Merit Laureate® hydrophilic guide wire in the United States.

New Product Acquisitions, Alliances and Distribution Agreements
In January, we purchased the Ostial PRO® stent positioning system. In February, we signed a distribution agreement for the Clo-Sur PLUS P.A.D.™ antimicrobial pressure applied device. In September, we purchased the Centros® long-term hemodialysis catheter (and added the CentrosFLO® long-term hemodialysis catheter). In November, we purchased the Flex-Neck® peritoneal dialysis catheter and related products. Recently we announced that Merit entered into a Stock Purchase Agreement to acquire Thomas Medical, Inc. from GE Healthcare, adding products that are recognized as “gold standard” by many of the leading cardiac rhythm management (CRM) and electrophysiology (EP) market participants.

New Facilities
By the end of the year Merit will complete the construction of a new 255,000 square-foot, state-of-the-art, finished goods warehouse and manufacturing facility in South Jordan. We also announced a new R&D facility in Pearland, Texas – a 118,000 square-foot, two-story facility. We completed the expansion of our “Vision Facility” in Galway, Ireland for the assembly of custom procedure packs in Europe.

New Employees
We’re doing our part to help the global economy through the creation of jobs. At the end of 2011, Merit employed about 2,400 employees worldwide, at the end of 2012 we employ more than 2,600 talented people who will help us grow in the future.

New Year
2012 was truly a great year for Merit, but 2013 looks even brighter! Each year we look forward to establishing annual priorities that will help us better serve our customers and further our mission and goals. I’m optimistic about what the New Year holds for our company and for our customers!

Larry Tolman, Vice President, Business Analytics

Merit Laureate® Hydrophilic Guide Wire and EN Snare® Endovascular Snare System Product Demonstrations Generate Interest at the 2012 TCT Meeting in Miami

The 2012 Transcatheter Cardiovascular Therapeutics (TCT) Meeting took place Oct. 23-25 at the Miami Beach Convention Center. Merit Medical’s booth was a frequently visited destination at the meeting. While many attendees enjoyed Merit Medical’s complimentary BowTie™ Guide Wire Insertion Device slush drink bar, the Merit Laureate, ONE Snare™*, EN Snare, Ostial PRO®, as well as the Radial Approach product demonstrations were the real draw.

Hands-on demonstrations of products provided attendees the opportunity to insert the Prelude® Sheath Introducers and to apply the Finale® Radial Compression Device on an anatomical model. The anatomical discovery models allowed attendees to see and feel the exceptional torque control and turn-for-turn responsiveness of the Merit Laureate Hydrophilic Guide Wire. The ONE Snare Single Loop Snare and the EN Snare Triple Loop Snare were demonstrated on a new discovery model with dual image screens and was a very popular demonstration.

Attendees showed a lot of interest in the Ostial PRO Stent Positioning System. This guide wire system is designed to provide consistent and precise stent placement in aorta-ostial lesions during coronary or peripheral interventional procedures.

Merit Medical had a great show and we are looking forward to continuing to provide product innovations and accessories designed to enhance the practice of interventional cardiology.

Patty Jabotte
Marketing Communications Manager

*510(k) Pending

Happy Thanksgiving From Merit Medical – Thank You for Being Part of Our World

In the spirit of Thanksgiving, Merit would like to sincerely thank our investors, customers, vendors, employees and our wonderful friends worldwide. The company exists and is growing because of you!

John F. Kennedy once said, “As we express our gratitude, we must never forget that the highest appreciation is not to utter words, but to live by them.” It is interesting to note that in many Latin languages “Happy Thanksgiving Day” is translated as a day of thankful “action.”

“¡Felíz día de Acción de Gracias!” (Spanish)
“Feliz dia de Ação de Graças!” (Portuguese)
“Bonne fête de l’Action de Grâces !” (French)

May our actions as a company always exemplify an attitude of gratitude for your contribution to our success!

Larry Tolman
Vice President, Business Analytics
Merit Medical Systems, Inc.

Introducing Merit Medical’s CentrosFLO® Chronic Dialysis Catheter Designed by Dr. Stephen Ash

Merit Medical is thrilled to announce the addition of the NEW CentrosFLO long-term hemodialysis catheter to its dialysis catheter line. This unique design features unique, preshaped, curved tips that automatically center the catheter ports within the middle of the vessel.

“The outward-curved limbs contact only one or two points within the lower SVC, minimizing the irritation of the SVC versus long straight-tip catheters,” Dr. Ash explained. The distal tip of the catheter has a unique curved configuration that keeps the ports of the catheter centered and away from vessel walls.

Initial in vitro bench testing showed minimal recirculation rates of less than 1% and flow rates well within the Kidney Disease Outcomes Quality Initiative (KDOQI) Guidelines. The CentrosFLO can be placed through a split sheath introducer or over-the-wire to suit your specific insertion needs. A unique, non-barbed tunneler is included in the CentrosFLO.

The CentrosFLO is a tremendous addition to Merit Medical’s dialysis catheter and accessory product offering and we are thrilled to have the opportunity to market this new line!

The NEW CentrosFLO – Centered on Performance

To find out more about the CentrosFLO long-term hemodialysis dialysis catheter, please call Merit Medical Customer Service at 1-800-35-MERIT.

Lynette Torman
Senior Product Manager

Merit Medical Makes InformationWeek List of Top Technology Innovators

As the Director of Sales & Marketing Technology at Merit, I’m proud to announce that Merit Medical was ranked 195 out of 500 companies on the InformationWeek 500 Top Technology Innovators. This annual list identifies the nation’s most innovative users of business technology. InformationWeek tracks the technology, strategies, investments, and administrative practices of some of America’s best-known companies.

We earned this recognition for our work developing, implementing and integrating state-of-the-art web and mobile systems for marketing disposable medical devices for use in interventional radiology and cardiology. Our innovations include:

• A new company website www.merit.com, including an online catalog, blogs and award-winning product videos for HepaSphere™ Microspheres and the Blue Diamond™ digital inflation device among others.

• Custom mobile applications, including native iPad and iPhone apps and cross-platform HTML5 apps such as the EN Snare® endovascular snare system snare size selection chart.

• Cloud architecture with software services, including Amazon Web Services, Salesforce.com, Google Apps, and eLeaP training, secured with Symplified single sign-on and unified with mashups.

• Social media outreach through a YouTube channel, Facebook page, Twitter feed, LinkedIn group, and Scribd library.

Learn more about the ranking by clicking on the following link:

http://www.informationweek.com/iw500/2012/viewList?sortby=Company&qNum=6

Lincoln Cannon
Director, Sales & Marketing Technology

Merit Medical to Exhibit at AIM VEITH in New York, November 14-17, 2012

Merit Medical is looking forward to exhibiting its innovative line of interventional radiology products when the Advanced Interventional Management (AIM) Symposium and VEITHsymposium™ are held in New York.

AIM is holding its 20th annual symposium on issues and techniques in interventional radiology and endovascular therapy. The VEITHsymposium™ provides Vascular Surgeons and Vascular Specialists the latest dialogue in clinical practice and research.

Merit Medical will be offering attendees hands-on demonstrations of the Merit Laureate® hydrophilic guide wire where physicians can experience true 1:1 torque.

Merit Medical will also highlight its suite of evidence-backed embolization products: Embosphere®, EmboGold®, and QuadraSphere® Microspheres, Merit Maestro® and EmboCath® Plus Microcatheters. The Tenor® and Sequitor® Steerable Guide Wires round out a portfolio that offers exceptional delivery systems for controlled, selective embolization.

On behalf of Merit Medical, I hope you’ll come to booth WP5 to learn more about our complete line of high quality interventional devices and accessories.

Sandra Anderson
Senior Product Manager

MAK-NV™ (Mini Access Kit Non-Vascular) Video Highlights Clinical Benefits of its Introducer System

I am pleased to announce the release of the MAK-NV Introducer System video.

Abscess, nephrostomy, biliary, cyst and other drainage procedure delays are often caused by:

· Introducer tip peelback,
· The inability to determine the exact location of the introducer tip, and
· Difficulty visualizing the needle tip.

The video highlights the clinical benefits offered by the MAK-NV introducer’s smooth transitions and radiopaque marker tip, as well as the MAK-NV needle’s echo-enhancement. The smooth transitions allow the MAK-NV Introducer System to track over the guide wire smoothly to minimize catching on tissue causing introducer peelback. The radiopaque marker tip on the introducer and echo-enhancement on the needle offer good visualization in the patient for accurate placement.

Visit www.merit.com to view the MAK-NV Introducer System video and for more information about our line of drainage products , which includes the ReSolve® drainage catheters, Revolution™ and StayFIX® catheter securement devices, Merit Drainage Depot™ drainage bag, and VacLok® vacuum pressure syringes.

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Having Options Matters

A recent survey conducted by Merit Medical, found that radiologists, cardiologists, and vascular surgeons use, on average, two different endovascular snare devices in their practice. These physicians understand the importance of having options when a foreign object such as an IVC filter, stent, broken catheter tip, or guide wire needs to be removed.

Merit Medical recognizes this need and is pleased to be the only provider of two snare devices: an interlaced triple loop device–the EN Snare® Endovascular Snare System, and a new, single loop snare device–the ONE Snare™ Endovascular Snare System. The ONE Snare™ and EN Snare® go hand-in-hand to provide physicians with the necessary options they need to meet any clinically-challenging case that may arise, because having options matters.

Check out the website to learn more about the ONE Snare™ and EN Snare® Endovascular Snare Systems.

Jesse Hansen
Senior Product Manager
Merit Medical

New! BowTie™ Guide Wire Insertion Device From Merit Medical

I’m thrilled to introduce the new BowTie™ Guide Wire Insertion Device, our innovative solution to the problem of aligning devices with micro guide wires.

Low lighting, small wires, and gloved hands make aligning devices used in diagnostic and interventional procedures difficult. The BowTie, named after its bow-tie shape, lines up wires and devices for quick and easy insertion. After loading, the flexible BowTie can be removed easily through a slit along the top of the device.

The BowTie will be available for hands-on demonstrations at CIRSE and TCT trade shows in September and October. We hope clinicians will be as excited as we are about this simple, elegant solution for “Making Ends Meet™.”

Stephanie Poulsen
Senior Product Manager
Merit Medical

Merit Medical Wins Telly Award for its Suite of Product Videos Produced by Lone Peak Productions, Inc.

Merit Medical is proud to announce that its product videos for HepaSphere™ Microspheres and Blue Diamond™ Digital Inflation Device won two Bronze Telly Awards in the Sales category at this year’s 33rd Annual Telly Awards.

The Telly Awards are given for web commercials, videos, and films, and outstanding local, regional, and cable TV commercials and programs. Entries are submitted from advertising agencies, production companies, television stations, cable operators, and corporate video departments around the world. Merit Medical’s videos were produced in conjunction with Lone Peak Productions, Inc. of Salt Lake City. The 33rd Annual Telly Awards received over 12,000 entries from all 50 states and 5 continents.

The videos showcase a number of Merit Medical products including HepaSphere Microspheres, designed for controlled, targeted embolization with or without delivery of doxorubicin HCI for the treatment of Hepatocellular Carcinoma (HCC) and the Blue Diamond Digital Inflation Device, a next-generation digital inflation device with a bold bright display that provides a high resolution visual representation of pressure.

To view these prize-winning videos, and our complete line of videos showcasing Merit Medical products, visit our website, www.merit.com.

Merit Medical to Attend CIRSE 2012 in Lisbon, Portugal September 15-19

Merit Medical will exhibit at booth number 25 during the 2012 meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) to be held in Lisbon, Portugal September 15-19. The CIRSE meeting is dedicated to education, science, and innovation in the field of Interventional Radiology and minimally invasive image-guided therapies. The programme is designed around seven main themes including Vascular Interventions, Transcatheter Embolization, Interventional Oncology, Neuro Interventions, Non-Vascular Interventions, IR Management, and Imaging.

With medical attendees from over 80 countries, CIRSE is a unique platform for interaction and for the exchange of scientific information. The educational programme provides the opportunity for physicians to familiarise themselves with new devices and to master new therapies, continually improving the service IR can provide for patients.

Merit Medical Releases Video for the Scion Clo-SurPLUS P.A.D.™

I am pleased to announce the availability of a new video for the Scion Clo-SurPLUS P.A.D. Antimicrobial Barrier. The Scion Cardio-Vascular CIo-SurPLUS P.A.D. is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy.

The video demonstrates the use of this versatile pad as an alternative to manual compression following catherization. The Clo-SurPLUS P.A.D. accelerates hemostasis plus protects against nosocomial infection, improving clinical efficiency while reducing complications, such as pseudoaneurysms and hematomas.1

To view the new CIo-SurPLUS P.A.D. video, click on the following link: http://www.merit.com/products/default.aspx?code=scion

Mark Heninger
Senior Product Manager, Merit Medical

[1] Invasive Cardiology: A Manual for Cath Lab Personnel, Pg. 396, Watson and Gorski

Construction of New Merit Medical Facility Underway in Pearland, Texas

Merit Medical broke ground early in 2012 and construction is underway on a new 107,000 square foot facility located in Pearland, Texas. Pearland is 12 miles south of Houston, Texas and approximately 30 miles northeast of Merit Medical’s Angleton facility.

The Pearland building is expected to be complete in May of 2013.

Merit Medical’s Innovation Chronicle™ Features Inventor of the Merit Maestro® Microcatheter Swan Neck Design

Merit Medical’s Innovation Chronicle newspaper was created to feature interviews with inventors, physicians, and authors about several Merit Medical products, including the Merit Maestro Microcatheter.

The Merit Maestro Microcatheter is preshaped and designed to access and maintain position in arteries with acute angles such as the hepatic artery. The secondary curve helps seat the catheter in the vessel to reduce the recoiling effect of the embolic agent as it is introduced. The preshaped distal end is ideal for access to the hepatic artery. Shinichi Hori, MD, PhD, the Director of the Gate Tower Institute for Image Guided Therapy in Japan, created the exclusive swan neck design of the Merit Maestro Microcatheter and offered his opinion on the advantages of its design. “Standard microcatheters have a change in flexibility and softness at each joint,” Hori observed. “Since the Merit Maestro has no joints, the catheter movement inside the blood vessel is very smooth.” Dr. Hori now uses the swan neck microcatheter for the majority of his cases where there are acute branch take-offs and vessel tortuosity.

The Merit Maestro multipurpose microcatheter was designed and engineered for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into peripheral and coronary vasculature. To read more about the Merit Maestro and other Merit Medical products used for embolic therapy such as QuadraSphere® microspheres, click on the link below.

Innovation Chronicle

Merit Medical Presents Radial Approach Product Options to Hospitals in Brazil

Merit Medical just completed a successful week of presentations on its radial approach product options to hospitals in Sao Paulo and Curitiba, Brazil.

Presentations and training for physicians and cath lab personnel included inservicing the radial approach using Merit Medical products from introduction to closure in approximately 20 cases. The training took place at Escola Paulista de Medicina Hospital, Dante Pazzanese Hospital, and Beneficencia Portuguesa Hospital (one of the largest cath labs in Latin America) in Sao Paulo and Hospital Cardiologico Costantini and Intercordis-Hospital Nossa Senhora das Graças in Curitiba.

The Merit Medical Radial Approach products used were Prelude® sheath introducers, Performa Ultimate™ diagnostic catheters, and the Finale® radial compression device. The Performa Ultimate 1 catheter was considered by many users to be preferable to the Terumo Tiger shape, especially when cannulating the RCA, LCA, and when performing a ventriculogram. The physicians and staff liked the Finale because they thought it was simple to use, does not occlude the ulnar artery, can easily check pressures, and quickly addresses decompression issues.

Merit Medical’s Radial Approach Product Demonstrations, Clo-Sur PLUS P.A.D.™ Generate Interest at Euro PCR 2012

Merit Medical’s booth was a popular destination at Euro PCR this year. While many attendees enjoyed Merit Medical’s complimentary coffee bar and excellent barista, the radial approach product demonstrations and new Clo-Sur PLUS P.A.D. were the real draw.

Hands-on demonstrations of products designed for the radial approach gave attendees the opportunity to insert Prelude® Sheath Introducers and to apply the Finale® Radial Compression Device on an anatomical model. The Performa Ultimate™ diagnostic catheters in four different curve variations were also available for demonstration.

Attendees showed a lot of interest in the Scion Clo-Sur PLUS P.A.D. This non-invasive topical hemostasis pad works as both an antimicrobial barrier and as a hemostasis pad for rapid control of bleeding. The pad is made of Polyprolate™, a biomedical grade form of chitosan.

Merit Medical had a great show and is looking forward to continuing to provide products and accessories designed to enhance the practice of interventional cardiology.

Merit Medical To Exhibit At The World Conference On Interventional Oncology in Chicago June 14-16

We hope to see you in Chicago next week when Merit Medical showcases its products at the World Conference on Interventional Oncology (WCIO). WCIO offers interventional radiologists, interventional oncologists, residents, and students from around the world hands-on workshops, panel discussions, and scientific programs on current treatments and future developments in interventional oncology for the treatment of cancer.

From microspheres to microcatheters, Merit Medical offers a complete embolic product portfolio to provide a high-performance delivery system for embolization procedures. Featured products will include QuadraSphere®, Embosphere®, and EmboGold® Microspheres, the Merit Maestro® Microcatheter, and the Tenor® Steerable Guidewire.

Visit Merit Medical at WCIO to learn more about our high-quality products and accessories designed to enhance the practice of interventional oncology.

Merit Medical Opens New Facility in Galway, Ireland

Merit Medical officially opened a new $25 million facility at the Parkmore Business Park East in Galway, Ireland on May 15, 2012. Merit Chairman and CEO Fred Lampropoulos and the Prime Minister of Ireland, Enda Kenny, spoke at the opening ceremony.

Prime Minister Kenny expressed his appreciation for Merit Medical’s investment in Ireland. Lampropoulos praised the Irish workforce: “Our high level of satisfaction with our Galway facility’s ability to take on new challenges and its successful track record in developing new products over the past 16 years were major factors in implementing this crucial investment there.”

The new 75,000 square foot building will be the principal site for the development and manufacture of guide wires and inflation devices such as InQwire® Guide Wires, Merit MAK™ Mini Access Kits, and BasixCOMPAK™ Inflation Devices.

Merit Medical’s Ireland facility is responsible for providing general, financial, and operational management to its European operations. Lampropoulos believes the new facility will play a significant role in increasing the company’s global business.

Merit Medical Hosted Industry Session and “Meet the Authors” Breakfast at Global Embolization Symposium and Technologies (GEST) in New York, May 3-6, 2012

Merit Medical exhibited at GEST, the “world’s foremost meeting on embolization,” in New York, May 3-6, 2012. GEST assembled experts from around the world to discuss the latest developments in embolization therapy and treatment. The symposium included lectures, panel discussions, demonstrations, and hands-on sessions.

Merit Medical sponsored an industry session on Thursday, May 3 from 12:30 to 1:15 P.M. Speakers Maurizio Grosso, MD and Julien Namur, PhD discussed “HepaSphere™ Microspheres for HCC: Patient Outcomes and Considerations in Embolic Sizing.”

Merit Medical also hosted a “Meet the Authors” breakfast reception on Friday, May 4 from 6:45 to 7:45 A.M. with innovators and thought leaders in Interventional Radiology and Oncology including Francisco Carnevale, MD, PhD, Alberto Antunes, MD, Maurizio Grosso, MD and Julien Namur, PhD.

We enjoyed hosting these events and talking with GEST attendees about our suite of tools for embolization procedures including the Merit Maestro® Microcatheter, Tenor® Steerable Guidewire, and other products designed to enhance the practice of interventional medicine.

Merit Medical Recognized as a Diamond Sponsor of Global Embolization Symposium and Technologies (GEST) 2012