AVF Cohort Data Presented From WRAP Global Registry of Merit’s Wrapsody CIE

November 12, 2026—Merit Medical Systems, Inc. announced results from the arteriovenous fistula (AVF) cohort of the WRAP Global registry, which is evaluating the company’s Wrapsody cell-impermeable endoprosthesis (CIE) for the treatment of stenosis or occlusion within the dialysis outflow circuit of an AVF or an arteriovenous graft.

The clinical data were presented during the New Innovations, Trials, Techniques, & Devices session on October 31 at CiDA, the Controversies in Dialysis Access conference in Washington, DC.

According to the company, the WRAP Global registry is an international, multicenter, prospective study designed to evaluate the performance of the Wrapsody CIE in real-world clinical practice through 24 months after device placement. A total of 237 patients were enrolled in the AVF cohort across 31 sites in nine countries.

Merit reported that the primary effectiveness endpoint of 6-month target lesion primary patency (TLPP) was 92.7%. Additionally, a secondary effectiveness endpoint of 6-month access circuit primary patency (ACPP) was 76.7%. These findings align with the 6-month patency rates observed in the AVF cohort in the WAVE pivotal trial of 89.8% TLPP and 72.8% ACPP, noted the company.

Panagiotis M. Kitrou, MD, and Dheeraj K. Rajan, MD, are Co-Global Principal Investigators of the WRAP Global registry.

“These are the results physicians have been waiting for,” commented Dr. Kitrou in Merit Medical’s press release. “Real-world insight regarding the patency of Wrapsody provides an important benchmark for this patient population.

Dr. Rajan added, “The promising patency outcomes from the WRAP Global registry are likely to improve physician confidence in the clinical benefits associated with Wrapsody and help to further optimize patient care.”

In addition to the WRAP Global registry, real-world clinical outcomes of the Wrapsody CIE are being evaluated in the WRAP North America registry, which is designed to enroll up to 250 patients in the United States and Canada, stated the company.

Merit Medical advised that the Wrapsody CIE received FDA approval in December 2024. Merit began commercialization of the device in the United States in January 2025. The device was approved by Health Canada in April 2025. It previously received CE Mark approval for commercial use in the European Union and is available in Brazil.