Merit Medical’s Wrapsody Endoprosthesis Evaluated in WAVE Pivotal Trial

September 16, 2024—Merit Medical Systems, Inc. announced 6-month findings from the randomized arteriovenous (AV) fistula arm of its Wrapsody Arteriovenous Access Efficacy (WAVE) pivotal trial. The trial is evaluating the company’s cell-impermeable Wrapsody endoprosthesis, which is intended to extend long-term vessel patency in dialysis patients.

The data were delivered in a First@CIRSE presentation during the Cardiovascular and Interventional Radiological Society of Europe’s CIRSE 2024 held September 14-18 in Lisbon, Portugal.

According to the company, the AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to the Wrapsody device or percutaneous transluminal angioplasty (PTA).

Merit Medical reported that target lesion primary patency in patients treated with Wrapsody was 27 percentage points higher than patients in the PTA cohort (89.8% vs 62.8%; P < .0001). The proportion of patients who experienced an adverse event was similar between cohorts.

The Coprincipal Investigators of the WAVE trial are interventional radiologist Mahmood K. Razavi, MD, and Robert G. Jones, MRCP, FRCR.

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.

“The superiority of the 6-month efficacy data is compelling and provides clinicians the chance to evaluate how Wrapsody can help us prolong the vascular access of our patients,” commented Dr. Razavi in Merit’s press release. “Wrapsody should be the new standard of care for these patients.”

Dr. Jones added, “Meeting with colleagues at CIRSE to discuss the AV fistula arm of the WAVE study was the first of what we hope to be many productive discussions. The potential for Wrapsody to help us safely extend vascular access for our patients is a vital component of care.”

Merit’s Wrapsody cell-impermeable endoprosthesis is available in the European Union and Brazil.

According to the company, findings from the WAVE study expand on results from the first-in-human study (Wrapsody FIRST), which were presented and published in September 2021, and support the premarket approval application to the FDA for commercial use in the United States.

In the United States, the device is being used under an FDA investigational device exemption. It is not approved or available for commercial distribution in the United States and may not be approved or available for sale or use in other countries, advised Merit Medical.