Merit Medical is thrilled to announce the launch of the True Form™ Reshapable Guide Wire, an innovative addition to our Interventional Oncology & Spine Delivery Systems Portfolio. The True Form is uniquely designed with a shapeable tip that can be shaped and reshaped multiple times for vessel cannulation, making it the go-to guide wire during […]
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.
- 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.
Hemodynamic Monitoring is Monitoring Life
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.
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.
- In-House Data
- Popma, J. (2013). Radial Artery Complication: Case Presentation. SCAI 2013. [PowerPoint slides].
- 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.
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.”
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
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.
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).
- 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.
- 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.
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 introduced 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.
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:
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.
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 […]
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.
- Clin J Am Soc Nephrol. 2011;6: 2247-52.
- J Vasc Surg. 2009;50: 600-607.
- J Surg Res. 2012;177: 165-171.
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.”
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:
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
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 […]
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.
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!
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
- 6F data on file
- 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.
- 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
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.
- 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.
- 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.
- 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.
- Radiology Masterclass. (n.d.). Basics of X-Ray Physics. Retreived from http://www.radiologymasterclass.co.uk/tutorials/physics/x-ray_physics_safety
- 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.
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