Merit’s Wrapsody WAVE Pivotal Study Completes Enrollment

August 3, 2023—Merit Medical Systems, Inc. announced the completion of enrollment in its Wrapsody Arteriovenous Access Efficacy (WAVE) pivotal study.

According to the company, WAVE is a prospective, randomized, controlled, multicenter study of the Merit Wrapsody cell-impermeable endoprosthesis (CIE) compared to percutaneous transluminal angioplasty for treatment of stenosis/occlusion in the venous outflow circuit in patients undergoing hemodialysis. Wrapsody was developed to help physicians treat patients with stenosis/occlusion in the vessels where arteriovenous (AV) fistula (AVF) or AV graft (AVG).

The WAVE study enrolled 244 patients with AVFs and 113 patients with AVGs across sites in Brazil, Canada, the United Kingdom, and the United States.

Merit stated that it intends to collect safety and efficacy outcomes throughout the study follow-up period. The company anticipates filing primary outcomes with the FDA for premarket approval after 6 months post enrollment completion. Merit intends to follow patients enrolled in the WAVE study for 24 months after completion of enrollment.

The WAVE study’s Coprincipal Investigators are Mahmood K. Razavi, MD, and Rob Jones, MBChB. Dr. Razavi is Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, California. Dr. Jones is consultant interventional radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, United Kingdom.

“Given the inadequacy of therapeutic options to maintain vascular access in hemodialysis patients, understanding Wrapsody’s overall performance—due to its unique cell-impermeable stent covering in helping to maintain AVFs and AVGs—is of high value to physicians and the scientific community,” commented Dr. Razavi in Merit Medical’s press release.

Dr. Jones added, “The WAVE study has now completed the anticipated recruitment thanks to the patients that participated and to the hard work of all the global investigators and their respective teams. I am looking forward to the data analysis and the next step in this device’s journey in providing definitive management to AV access patients.”

Merit Medical advised that the Wrapsody CIE is not approved, cleared, or available for commercial distribution in the United States and may not be approved, cleared, or available for sale or use in other countries. In May 2020, the company announced that the Wrapsody device received CE Mark approval for commercial use in the European Union. It is also available in Brazil, noted Merit Medical.

In the United States, the device is being used under an investigational device exemption from the FDA. Findings from the WAVE study are expected to expand upon results from the WRAPSODY FIRST first-in-human study, which were announced in September 2021, and support the premarket approval application to the FDA for commercial use in the United States.