Merit Medical to Present 6-Month Outcomes from Randomized Arm of WRAPSODY™ Arteriovenous Access Efficacy (WAVE) Pivotal Study at Two Upcoming Medical Meetings

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[{"type":"text","content":"SOUTH JORDAN, Utah, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced plans to release findings from its WAVE study. A pivotal, international, multicenter trial, the WAVE study examines the safety and efficacy of Merit’s WRAPSODY Cell-Impermeable Endoprosthesis for treatment of stenosis in the venous outflow circuit. The WAVE study enrolled 245 patients with stenosis in their arteriovenous fistula (AVF) and 113 patients with evidence of stenosis in their arteriovenous graft (AVG). Patients with an AVF were randomized 1:1 to treatment with WRAPSODY or standard of care with percutaneous transluminal angioplasty (PTA). Safety and performance outcomes of patients with an AVG were compared to historical controls. Patients enrolled in WAVE will be followed for 24 months after their initial intervention. Six-month safety and efficacy findings will be presented at multiple congresses this year. The first release of results will focus exclusively on patients from the randomized arm of the study (AVF cohort) and is scheduled for scientific presentation at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Lisbon, Portugal. The presentation is scheduled for Saturday, September 14, during the FIRST@CIRSE scientific session held from 11:30 a.m. to 12:30 p.m. (CEST); specific results at 6 months will include target lesion primary patency, access circuit primary patency, and safety events. “Given the limited options available to help maintain the vascular access in patients requiring hemodialysis, it is critical to provide the clinical community with information on the latest technology designed to help us optimize care for such a vulnerable patient group,” said Mahmood K. Razavi, MD, FSIR, FSVM, Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, California, and Co-Global Principal Investigator of the WAVE study. “I look forward to presenting the first release of the findings at CIRSE.” Following the presentation of 6-month outcomes of the randomized arm of the WAVE study, there will be a Merit-sponsored symposium at CIRSE on Monday, September 16, from 1:00 p.m. to 2:00 p.m. (CEST), with a panel of renowned experts highlighting the latest hemodialysis evidence and clinical strategies. On Tuesd...

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