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.

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 Donates PD Catheters for Stuffed Animals to Comfort Young Patients

Child with peritoneal dialysis catheterRecently 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!”

Stuffed animal with peritoneal dialysis catheterTubie 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

Merit Medical Peritoneal Dialysis

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

 

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

SureCross Support Catheter Guide Wire comparison graphic
Contact your Merit Sales Representative to evaluate the SureCross Support Catheter today.

Tami Anderson
Senior Product 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

CentrosFLO long-term hemodialysis catheters

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

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

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

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.

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

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.

EN Snare® Endovascular Snare System and ONE Snare® Endovascular Snare System

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