Staying True to Form: Merit Announces the Launch of Its Cutting-Edge Reshapable Guide Wire

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 endovascular intervention procedures.

“The ability of the True Form Guide Wire to be shaped multiple times and keep its shape allows me to use the same guide wire, decreasing the need to use additional guide wires,” says Dr. Shinichi Hori, Chief Physician and Director at Gate Tower Institute for Image Guided Therapy in Osaka, Japan.

Other noteworthy features include a stainless steel core that provides excellent support for devices and a flexible shaft for navigation through tortuous anatomy. When compared to competing guide wires, the True Form hydrophilic coating is up to 7 times more lubricious, resulting in less guide wire drag.1

The True From is also compatible with several microcatheters, including the Merit Maestro®. With a flexible, hydrophilic-coated distal region, nylon ribbon braiding, and a Swan Neck designed tip, the Maestro provides superior pushability, trackability, and flexibility.

Merit knows that having a reliable microcatheter during embolization will enhance procedural efficiency and provide the outcomes expected for small vessel embolization. This is exactly why we’re prepackaging the Maestro Microcatheter 2.4F with the True Form Reshapable Guide Wire.  

Delivering this dynamic duo together in one box affords both convenience and ease of use from start to finish. Ordering is effortless when a preferred guide wire and microcatheter can be bought together with only one purchase order. What’s more, supplying these tools in a prepackaged form removes the unnecessary step of finding a guide wire and microcatheter that fit because clinicians already know the True Form and Maestro are compatible. Storing is also made simple by only needing to stock and pull one box from the shelf.

The True Form Reshapable Guide Wire comes in several lengths to match diverse patient anatomy. For more information, visit https://www.merit.com/interventional-oncology-spine/accessories/guidewires/true-form-steerable-guide-wire/ or talk to your Merit representative today.

  1. Data on file

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

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.

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.

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

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 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.


“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

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

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.

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 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.

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/

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