Eco Wave Power AB (publ)(US:WAVE) GlobeNewswire News Room·2024-08-01 20:05Core Insights - Merit Medical Systems, Inc. is set to release findings from the WAVE study, which evaluates the safety and efficacy of the WRAPSODY Cell-Impermeable Endoprosthesis for treating stenosis in the venous outflow circuit [1][6] Study Details - The WAVE study enrolled 245 patients with stenosis in arteriovenous fistula (AVF) and 113 patients with stenosis in arteriovenous graft (AVG) [2] - Patients with AVF were randomized 1:1 to receive either WRAPSODY or standard care with percutaneous transluminal angioplasty (PTA) [2] - The study will follow patients for 24 months, with six-month safety and efficacy findings to be presented at various congresses this year [2] Presentation Schedule - The first results will focus on the AVF cohort and will be presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 14 [3] - Specific results at six months will include target lesion primary patency, access circuit primary patency, and safety events [3] - A Merit-sponsored symposium will follow the presentation on September 16, featuring discussions on hemodialysis evidence and clinical strategies [4] Additional Findings - Core laboratory findings supporting the cell-impermeable design of WRAPSODY will be presented at the Controversies in Dialysis Access (CiDA) Symposium on October 5 [5] - The findings from the WAVE study are expected to support the Premarket Approval (PMA) application to the FDA for WRAPSODY, which is currently under an Investigational Device Exemption (IDE) [6] Company Background - Merit Medical Systems, Inc. was founded in 1987 and specializes in developing, manufacturing, and distributing proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures [7] - The company employs approximately 7,000 people worldwide and serves client hospitals globally with a dedicated sales force and clinical support team [7]