Merit Medical Announces Health Canada Approval of the WRAPSODY® Cell-Impermeable Endoprosthesis
- The WRAPSODY CIE is designed to help physicians prolong functional vascular access in hemodialysis patients.
- Approval was supported by superior 12-month target lesion primary patency (70.1%) and access circuit primary patency (58.1%) in the randomized arm of the trial.
SOUTH JORDAN, Utah, May 06, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, announced today that the Wrapsody Cell-Impermeable Endoprosthesis (CIE) received regulatory approval from Health Canada. With this approval, Merit intends to begin immediate commercialization of the device throughout Canada with devices shipped from Merit's Toronto distribution center.
Long-term access to blood vessels (vascular access) is critical for patients undergoing hemodialysis. However, stenosis, a narrowing of blood vessels, is a common complication that can have life-threatening consequences if not resolved. Intervention options for patients affected by stenosis have been limited. The WRAPSODY CIE was developed to help physicians effectively treat patients on hemodialysis who experience vascular access stenosis.
In 2010, Merit set out to understand how and why previous devices failed to provide lasting benefits to patients. It became evident that in the previous generation of covered stents/stent grafts a substantial cause of device failure and, ultimately, loss of vascular access, was the presence of tissue within the polytetrafluoroethylene (PTFE) layer.
With this understanding and key clinical insight from Bart Dolmatch, MD, FSIR, Interventional Radiologist at The Palo Alto Medical Foundation in Palo Alto, California, engineers at Merit designed the WRAPSODY CIE. The tri-layer design of the device is unlike any other treatment option currently available. The three layers of the WRAPSODY CIE consist of: (1) an expandable nitinol stent frame fully enveloped by an outer layer of expanded PTFE; (2) a cell-impermeable middle layer that prevents tissue accumulation and migration; and (3) an innermost internal layer that consists of novel "spun" PTFE to reduce fibrin and thrombus formation. Other unique features of the WRAPSODY CIE include optimized radial force, high compression resistance, and softened ends, all of which help the device conform to vessels, reduce stress, and improve dialysis effectiveness. "I believe all of these advancements will translate to better outcomes for patients on hemodialysis," said Dr. Dolmatch, who was instrumental in the development of the WRAPSODY CIE.
Results from the randomized arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial demonstrated that the WRAPSODY CIE is associated with significantly higher primary patency compared to percutaneous transluminal angioplasty (PTA). At six months, the target lesion primary patency of the WRAPSODY CIE vs. PTA was 89.8% vs. 62.8% (p<0.0001), and the access circuit primary patency was 72.6% vs. 57.9% (p=0.015). At 12 months, the WRAPSODY CIE remained significantly higher than PTA for both target lesion primary patency (70.1% vs. 41.6%, p<0.0001) and access circuit primary patency (58.1% vs. 34.4%, p=0.0003).
"Given the unique vulnerabilities patients on hemodialysis experience, WRAPSODY's ability to restore vascular access functionality and avoid disruptions in hemodialysis administration is of high value to patients and providers," said Dheeraj K. Rajan, MD, FRCPC, FSIR, FACR, Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, and an investigator in the WAVE trial. "The fact that WRAPSODY is associated with high target lesion and access circuit primary patencies not previously observed in any similar clinical trial to date is compelling and will provide the option to raise the standard for best patient care in Canada."
"Our WRAPSODY journey is a testament to our determination at Merit to understand, innovate, and deliver the highest quality products to help our physician partners achieve the best outcomes possible for patients," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "We are committed to remaining at the forefront of hemodialysis care."
The WRAPSODY CIE received premarket approval (PMA) from the US Food and Drug Administration (FDA) in December 2024. Merit began commercialization of the device in the United States in January 2025. The device previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
For additional information on Merit Medical's WAVE trial, please visit: https://clinicaltrials.gov/ct2/show/NCT04540302.
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide.
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