Merit Medical disclosed that the 24‑month efficacy data for its WRAPSODY Cell‑Impermeable Endoprosthesis (CIE) in the arteriovenous graft (AVG) cohort of the WAVE trial were presented at the VIVA Foundation VEINS conference on November 4, 2025. The single‑arm study enrolled 112 patients across 43 centers in the United States, South America, and the United Kingdom, providing a robust, real‑world assessment of the device’s long‑term performance.
The trial’s primary patency metrics demonstrate sustained durability: target lesion primary patency (TLPP) reached 81.4% at 6 months—well above the 60 % performance goal—then 60.2% at 12 months and 41.7% at 24 months. Access circuit primary patency (ACPP) was 36.2% at 12 months and 25.7% at 24 months, underscoring the device’s ability to maintain clinical benefit over two years.
Clinically, these results suggest that WRAPSODY CIE can extend the functional life of failing AVGs, potentially reducing the need for repeat interventions. For patients, this translates into fewer procedures and improved quality of life, while for Merit Medical it supports the company’s strategy to broaden U.S. commercialization and capture a larger share of the dialysis‑access market.
Dr. Mahmood K. Razavi, a trial investigator, noted that “the WRAPSODY CIE offers patients with a failing AVG the opportunity to extend vascular access, and the 24‑month efficacy results will be of the utmost importance to physicians.” His comment highlights the clinical relevance of the data and reinforces Merit’s positioning as a provider of durable access solutions.
The company has already secured regulatory approvals—FDA pre‑market approval on December 19, 2024, Health Canada approval on April 30, 2025, and a CE mark for the European Union—and the device is available in Brazil. Real‑world outcomes are being collected through the WRAP North America Registry and WRAP Global Registry, which will further validate the device’s performance in routine practice.
No market reaction or analyst commentary was identified in the fact‑check sources, indicating that the announcement has not yet triggered a measurable response from investors or the broader market.
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