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

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

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

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

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

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

Worley™ Advanced CSG

Worley™ Advanced LVI

Worley™ Vein Selector

Matt Toone
Marketing Director, EP

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

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

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

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

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

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

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

Additional features:

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

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


Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Ostial PRO® Debuts in Turkey

Ostial PRO in Turkey

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

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

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

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

1 Data on file.

New Video Showcases Radial Portfolio

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

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

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

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

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

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

Mark Heninger
Senior Product Manager

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

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

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

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

To learn more, visit the ONE Snare product webpage.

Jesse Hansen
Marketing Director

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

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

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

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

Look forward to seeing you at VEITH!

Jesse Hansen
Marketing Director

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

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

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

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

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

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

Lynette Ruppel
Senior Product Manager

image3-21

HepaSphere Microspheres Absorb Both Mechanically and Ionically for Optimal Doxorubicin Loading

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

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

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

High Drug Loadability

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

HepaSphere Mechanical Interaction

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

HepaSphere Ionic Interaction

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

Increased Tumour Necrosis

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

Efficient Loading

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

HepaSphere Microspheres load doxorubicin throughout the microsphere.

HepaSphere bead

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

HepaSphere bead competitor

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

HepaSphere Microspheres Lyophilized Doxorubicin Mixing Chart

HepaSphere Microspheres Presolubilized Doxorubicin Mixing Chart

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

Antonio Rivera, BSRT, MSHS

Global Product Manager

——————————————–

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

References

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

 hepasphere

 

 

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

closurepadCardiac Interventions News presented in its May/June issue a study at the 2014 scientific sessions of The Society for Cardiovascular Angiography and Interventions (SCAI) entitled, “Femoral Artery Compromise from Cardiac Catheterization in Children–a Multicenter Study by the CCISC (Congenital Cardiovascular Interventional Study Consortium)” by Thomas J. Forbes, MD. The study concluded that the use of a 3 Fr sheath and hemostasis patch significantly reduced the risk of femoral artery compromise. The study found that “…when a ahemostatic patch was used to seal the wound, the risk of femoral compromise was reduced by approximately two-thirds compared with manual pressure alone.”
The Scion Clo-Sur
PLUS P.A.D.™, sold by Merit Medical, is a sterile topical hemostasis pad intended for the local management of bleeding wounds, including vascular procedure sites.
To learn more about the Scion Clo-sur
PLUS P.A.D., please visit the product’s web page, or contact your Merit Medical Sales Representative.

Mark Heninger
Senior Product Manager

 

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

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

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

NEEDLE

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

GUIDE WIRE

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

INTRODUCER

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

DILATOR

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

GUIDE WIRE ALIGNMENT DEVICE

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

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

Chan Ream
Product Manager
Vascular Access

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

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

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

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

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

We look forward to seeing you at CIDA!

Nate Smith
Senior Product Manager
Hemodialysis

Lynette Ruppel
Senior Product Manager
Peritoneal Dialysis

Merit Medical Announces The Launch Of The SureCross® Support Catheter

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

TRACKABILITY – SHAFT TECHNOLOGY 

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

PUSHABILITY – GUIDE WIRE COMPATIBILITY 

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

VISIBILITY – TIP DESIGN 

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

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

Tami Anderson
Senior Product Manager

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

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

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

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

Michelle Stevens
Merit OEM Senior Marketing Communications Manager

    

Treatment of Metastatic Spinal Lesions with a Navigational Bipolar Radiofrequency Ablation Device: A Multicenter Retrospective Study

Praveen R. Anchala, MD, Winston D. Irving, MD, Travis J. Hillen, MD, Michael V. Friedman, MD, Bassem A. Georgy, MD, Douglass, M. Coldwell, MD, PhD, Nam D. Tran, MD, PhD, Frank D. Vrionis MD, PhD, Allan Brook, MD, and Jack W. Jennings, MD, PhD

Article presented the reality of fast and lasting relief from painful metastatic lesions

Praveen study 1

Conclusions

The STAR Tumor Ablation System:

  • Was safely & effectively used in the treatment of metastatic spinal tumors
  • Allowed RFA treatment of previously untreatable lesions which resulted in reduction of pain that was not controlled with systemic or radiation therapy
  • In certain cases with posterior wall involvement, posterior extension of tumor was halted
  • Did not hinder or delay other therapies

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

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

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

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

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

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

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

Additional features:

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

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

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

PreludeEASE™ Hydrophilic Sheath Introducer Receives CE Mark

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

PreludeEASEbannerV3

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

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

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

Stephanie Poulsen
Senior Product Manager

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

Merit Medical EMEA Launches Website

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

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

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

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

ABOUT MERIT MEDICAL SYSTEMS, Inc. 

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

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

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

COMPRESSION 
safeguard

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

CONVENIENCE 

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

COMFORT 

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

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

Schedule an evaluation of the Safeguard Radial

Stephanie Poulsen
Senior Product Manager

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

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

Multi-Center Trial Shows Significant Pain Relief For Spine Cancer Patients Following Targeted Radiofrequency Ablation Treatment

SAN JOSE, Calif. – July 21, 2014 – DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced the publication of a multi-center study in the July/August issue of Pain Physician Journal, the official peer-reviewed publication of the American Society of Interventional Pain Physicians (ASIPP). The study followed patients at five leading academic centers and found a significant decrease (p<0.01) in pain scores after Targeted Radiofrequency Ablation™ (t-RFA) with the STAR Tumor Ablation System™.The participating centers included Washington University School of Medicine, Moffitt Cancer Center, Montefiore Medical Center and the Albert Einstein College of Medicine, University of Louisville Hospital and the University of California, San Diego. Physicians treated 128 lesions (metastatic tumors) in 92 patients. The average pain score before the procedure was 7.51 out of 10. Within one week post-procedure, the average pain score was reduced to just 1.73. Researchers also noted no patient complications or injuries.

“More than 40 percent of patients at the highest enrolling institution in this study had previous radiation treatment with little to no relief of symptoms,” said Jack W. Jennings, M.D., Ph.D, Assistant Professor and Director of Musculoskeletal and Spine Interventions, Mallinckrodt Institute of Radiology, Washington University School of Medicine in St. Louis. “Our study showed significant and almost immediate reduction in pain and more than half of the patients also decreased their use of pain medication. The procedure also allowed us to treat tumors close to the spinal cord that we have not been able to treat in the past.”

The American Cancer Society estimates that in 2014 there will be more than 1.7 million new cancer cases diagnosed and 585,720 cancer deaths in the United States.1 Metastatic lesions in bone are common and have been seen in up to 80 percent of patients with cancer at the time of death,2 with spinal metastasis seen in approximately 50 percent of these patients.3

“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, M.D., and Ph.D., neurooncology surgeon at Moffitt Cancer Center. “This multi-center study validates t-RFA as a treatment option that provides rapid, lasting pain relief without the need to interrupt the patient’s primary cancer therapy.”

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

Treatment of Metastatic Posterior Vertebral Body Osseous Tumors by Using a Targeted Bipolar Radiofrequency Ablation Device: Technical Note

Travis J. Hillen, MD, Praveen R. Anchala, MD, Michael V. Friedman, and Jack W. Jennings, MD, PhD. Hillen, et al., Radiology. 2014 June 13:131664, E-pub prior to print Pubmed ID: 24927327   This article presented how targeted Radiofrequency Ablation (t-RFA) with the STAR Tumor Ablation System can serve as a Minimally Invasive Solution to Safely and Effectively Treat Previously Inaccessible Spinal Lesions

clinical-star-metastatic-rcc-case-study

Conclusions

The STAR Tumor Ablation System:

  • Provides access to tumors that are difficult to reach with conventional ablation systems
  • Allows for safe & controlled ablation of spinal tumors
  • Does not hinder or delay other therapies
  • May provide an alternate therapy for tumors that do not respond to chemotherapy or radiation therapy

ReSolve® Biliary Locking Drainage Catheter Receives CE Mark!

resolvebiliary-new

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

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

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

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

Additional features:

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

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

Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Merit Medical Hosts Medical Education Course on LV Implantation Techniques

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

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

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

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

Worley™ Advanced CSG

Worley™ Advanced LVI

Worley™ Vein Selector

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

Nelson Gardner
Business Development Manager

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

DFINE Announces Commencement Of Clinical Study On Spinal Tumor Ablation With The STAR Tumor Ablation System

San Jose, Calif. and Magdeburg, Germany – June 11, 2014DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced that the first patient has been enrolled in the EU-STAR Clinical Trial. The multi-center trial is the first prospective study to evaluate clinical outcomes in patients receiving treatment with the STAR™ Tumor Ablation System for the palliative treatment of metastatic spinal tumors.

DFINE will enroll 40 patients at five centers in Germany and France. The trial will evaluate pain relief at one month as a primary outcome measure with follow up through six months. Secondary outcome measures include change in function, quality of life and pain medications post-procedure.

“We’ve had very promising results with targeted RF ablation (t-RFA™) to ‘melt’ the tumor followed by RF targeted vertebral augmentation™ (RF-TVA) during the same procedure to repair the damaged vertebrae,” said Dr. Boris Joellenbeck, a principal investigator at The Otto-von-Guericke University Magdeburg in Germany, where the first patient was treated. “Immediately following the procedure, the patient had a significant reduction in pain and increased activity level. We are excited about the many potential benefits of this therapeutic approach for our patients.”

Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone.1 When cancer is not found early, it can metastasize (spread) to other parts of the body. A spinal tumor is a growth of cells (mass) in or around the vertebra near the spinal cord. It is estimated that 30-40 percent of cancer patients will likely develop metastatic spinal tumors.Many of these tumors also result in fractures of the vertebrae.

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE. “As a company we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in Germany and France on this landmark trial.”

To learn more about the EU-STAR clinical trial (ID # NCT02081053), interested parties may contact the study research staff found here: http://www.clinicaltrials.gov/ct2/show/NCT02081053 

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

About DFINE, Inc.

DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company.

DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc. [media-contact]

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

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

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

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

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

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

Chan Ream
Product Manager

Merit Medical To Exhibit at PICS-AICS 2014 Chicago Symposium

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

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

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

New to our pediatric product line this year are:

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

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

Tami Anderson
Senior Product Manager

Safeguard® and Ergonomics in the Cath Lab

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

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

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

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

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

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

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

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

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

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

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

Mark Heninger
Senior Product Manager

Merit Medical Offers PD Kit for Interventional Radiologists

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

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

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

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

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

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

Lynette Ruppel
Senior Product Manager

The Importance of Having Options for Foreign Body Manipulation and Retrieval

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

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

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

Jesse Hansen
Director of Marketing – Interventional Radiology

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

centrocaths

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

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

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

Self-Centering,
Split-Tip Design
(n = 38)
Symmetric-Tip
Design
(n = 20)
Statistical
Probability
Patency94.7%75.0%P = 0.04
Mean Clearance (Kt/V)21.4831.423NSD4 (p = 0.48)
Mean Blood Flow (ml/min)2393.93381.63NSD4 (p = 0.27)

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

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

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

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

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

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

These catheters continue to offer

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

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

Ask4UFE Website Revamped

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

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

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

Sincerely,
Your friends at Ask4UFE

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

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

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

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

Prelude® Radial Sheath Introducers
Efficient access with smooth transitions

InQwire® Diagnostic Guide Wire
Excellent navigation with PTFE coating

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

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

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

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

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

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

Merit Medical Announces Launch of New Corporate Video

Merit Medical has released a new corporate video!

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

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

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

Monica Haines
Senior Marketing Communications Manager

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

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

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

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

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

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

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

Mark Heninger
Senior Product Manager

Merit Medical Opens Office in Bangalore, India

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

image1-16

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

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

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

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

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

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

image1-16CONTROL 

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

COVERAGE 

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

COMFORT 

  • Ergonomic shape
  • Improved grip size

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

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

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

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

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

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

Hope to see you there!

Jesse Hansen
Director of Marketing – Interventional Radiology

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

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

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

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

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

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

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

Tami Anderson,
Senior Product Manager

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

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

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

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

Nathan Smith
Senior Product Manager

1Data on file

New Studies Highlight Benefits Of STAR Tumor Ablation System For Patients With Spinal Tumors

San Jose, Calif. – Feb. 18, 2014 –Two studies presented at the American Society of Spine Radiology (ASSR) 2014 Annual Symposium in Miami highlighted the benefits of Targeted Radiofrequency Ablation™ (t-RFA) therapy with the DFINE STAR™ Tumor Ablation System. The studies demonstrated the ability of the STAR System to provide significant pain relief to patients suffering from painful spinal metatases; in many cases, these patients had not responded to standard therapies, such as radiation or chemotherapy. The first study, conducted by Bassem Georgy, M.D., Assistant Clinical Professor of Radiology at the University of California, San Diego, noted improvement in pain and functional status (quality of life) in all patients. The study also concluded that the targeted and minimally invasive nature of the STAR System allowed treatment of all of the studied tumors regardless of their location. The second study, conducted by Jack Jennings, M.D., PhD, Director of Musculoskeletal and Spine Interventions at the Mallinckrodt Institute of Radiology in St. Louis, demonstrated the value of the STAR System in treating patients who were not responsive to other standard treatments and who had tumors very close to the spinal cord (posterior lesions). In addition to relieving pain, the study concluded that the STAR System had successfully destroyed the lesions, and that in many patients no regrowth was observed during the study period.< “We are pleased with the continued success of STAR in providing pain relief to the many cancer patients suffering from spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE. “The therapy continues to gain momentum and we are gratified to see more clinicians embracing the technology to help their patients.” About STAR™ Tumor Ablation System The STAR Tumor Ablation System does not treat cancer. It was cleared by the FDA in 2010 for providing palliative treatment (e.g., pain relief) by ablation of metastatic malignant tumors in a vertebral body. With its use of targeted radiofrequency (RF) energy, the STAR System enables physicians to achieve pain relief through the use of a single, minimally invasive procedure that may be compatible with both chemo and radiation therapy. As with all surgical procedures, there are risks and contraindications associated with the STAR System which are described in the product labeling.  The STAR System is available at more than 200 institutions in the U.S. For more information regarding spinal tumors or to find a physician, visit http://www.spine-tumors.com. About STAR™ Tumor Ablation System t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR About DFINE, Inc.DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company. DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc. Media Contact Susan Benton Russell T: 310-697-3488 [email protected]

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

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

image1-16

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

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

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

image2-19

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

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

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

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

Lynette Ruppel
Senior Product Manager

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

 

laureatehydrophillicguidewire

AVAILABLE IN NEW 0.018″ DIAMETER

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

THE MERIT LAUREATE OFFERS

  • True 1:1 torque control for greater turn-for-turn responsiveness and rapid vessel selection
  • Reliable and lasting lubricity to minimize surface friction for navigating highly tortuous anatomy and rapid catheter exchanges
  • Enhanced lesion crossability
  • Dependable visualization under fluoroscopy

Available now in 0.018″, 0.025″, 0.035″, and 0.038″ diameters, 80 cm to 260 cm lengths, standard and stiff body, with angled and straight tip configurations. Click here to watch our Merit Laureate Product Demonstration Video with side- by-side comparison to the market leader and a product feature animation.

PENNY GOLDMAN
Senior Product Manager

Merit Medical to Showcase HeartSpan® Product Portfolio at the AF Symposium Jan 9-11 in Orlando

Merit Medical will be showcasing its electrophysiology product line at the 19th International AF Symposium on atrial fibrillation in Orlando, Florida.

Visit us at Booth 501 for a hands-on demonstration of the new HeartSpan® Steerable Sheath. Attendees will be able to experience the comfort and control of the larger handle and its bidirectional articulation with a hands-on demonstration on a tabletop vascular model.

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

For comfortable, convenient hemostasis following your EP and CRM procedures, Merit offers the Safeguard® 24 cm Pressure Assisted Device designed for compression of femoral access sites.

Our EP team looks forward to meeting attendees and introducing them to Merit’s extensive line of products for advancing CRT Delivery and LV Lead Implantation.

Jon Jensen Senior Product Manager