Efficacy Outcomes From AVG Cohort of WAVE Presented for Merit’s Wrapsody CIE

November 3, 2025—Merit Medical Systems, Inc. announced 24-month efficacy outcomes from the nonrandomized arteriovenous graft (AVG) cohort of the WAVE trial. Merit’s Wrapsody cell-impermeable endoprosthesis (CIE) is intended to help maintain vascular access for patients on hemodialysis who experience access circuit stenosis or occlusion.

The study findings were presented by Coglobal Principal Investigator Mahmood K. Razavi, MD, during the late-breaking clinical trials session at the annual VEINS conference held by the VIVA Foundation.

According to the company, the WAVE trial assessed the ability of the Wrapsody device to restore and maintain functional vascular access by evaluating target lesion primary patency (TLPP) and access circuit primary patency (ACPP). The study was conducted at 43 centers across the United States, South America, and the United Kingdom.

In the nonrandomized arm, 112 patients with stenosis or occlusion in the AVG underwent treatment with the Wrapsody CIE.

Merit reported the following:

• TLPP at 6 months significantly exceeded the prespecified performance goal (81.4% vs 60%; P < .0001).
• TLPP rates at 12- and 24-month follow-up were 60.2% and 41.7%, respectively.
• ACPP rates were 36.2% at 12 months and 25.7% at 24 months.

“The ability of the Wrapsody CIE to offer patients with a failing AVG the opportunity to extend vascular access is promising; the 24-month efficacy results will be of the utmost importance to physicians,” commented Dr. Razavi in Merit’s press release.

Merit advised that real-world performance of the device is being assessed in the WRAP North America registry and the WRAP Global registry outside North America.

The Wrapsody CIE received FDA premarket approval in December 2024, Health Canada approval in April 2025, and European CE Mark approval in 2020. It is also available in Brazil, noted the company.