Merit Medical Announces FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis

Core Insights - Merit Medical Systems, Inc. has received premarket approval from the US FDA for the WRAPSODY Cell-Impermeable Endoprosthesis, allowing for commercialization in the USA starting in 2025 [6] - The WRAPSODY device is designed to improve long-term vessel patency in hemodialysis patients, addressing common issues such as stenosis and thrombosis [12][19] - Clinical trial results indicate high efficacy of the WRAPSODY device, with primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months [18] Company Overview - Merit Medical, founded in 1987, specializes in the development, manufacture, and distribution of proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures [10] - The company employs approximately 7,200 individuals globally and serves hospitals worldwide with a dedicated sales force and clinical support team [10] Product Details - The WRAPSODY device features a unique design with a nitinol stent frame and a multi-layer structure aimed at reducing tissue accumulation and improving blood flow [7][12] - The device is indicated for use in treating stenosis or occlusion in the dialysis access outflow circuit, specifically in peripheral veins of individuals with AV fistulas and at the venous anastomosis of synthetic AV grafts [11] Market Context - In the United States, approximately 687,000 procedures are performed annually to maintain dialysis access, with nearly 100,000 involving stent placement [17] - The WRAPSODY device is expected to set a new standard of care in the treatment of vascular access complications for dialysis patients, as indicated by the positive outcomes from the WAVE trial [19]