Merit Medical announces Health Canada approval of WRAPSODY CIE

Merit Medical (MMSI) Systems announced that the Wrapsody Cell-Impermeable Endoprosthesis 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 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 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: an expandable nitinol stent frame fully enveloped by an outer layer of expanded PTFE; a cell-impermeable middle layer that prevents tissue accumulation and migration; and 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 trial demonstrated that the WRAPSODY CIE is associated with significantly higher primary patency compared to percutaneous transluminal angioplasty. At six months, the target lesion primary patency of the WRAPSODY CIE vs. PTA was 89.8% vs. 62.8%, and the access circuit primary patency was 72.6% vs. 57.9%. At 12 months, the WRAPSODY CIE remained significantly higher than PTA for both target lesion primary patency and access circuit primary patency.