Business UpdateNov 5, 2026, 09:26 AM
Merit Medical WRAPSODY CIE Shows 92.7% Patency in Real-World Registry
AI Summary
Merit Medical Systems, Inc. announced positive results from the AVF cohort of the WRAP Global registry for its WRAPSODY™ Cell-Impermeable Endoprosthesis (CIE). The 6-month target lesion primary patency (TLPP) was 92.7% and access circuit primary patency (ACPP) was 76.7%, exceeding results from the pivotal WAVE trial. These real-world data, presented at the Controversies in Dialysis Access (CiDA) conference, demonstrate the device's favorable performance in routine clinical practice. The WRAPSODY CIE, approved by the FDA in December 2024 and Health Canada in April 2025, is designed to restore functionality in vascular access for hemodialysis patients.
Key Highlights
- 6-month target lesion primary patency (TLPP) for AVF cohort was 92.7%.
- 6-month access circuit primary patency (ACPP) for AVF cohort was 76.7%.
- Real-world patency results are higher than the pivotal WAVE trial.
- WRAP Global registry enrolled 237 patients in the AVF cohort across 31 sites in nine countries.
- WRAPSODY CIE received FDA approval in December 2024 and Health Canada approval in April 2025.
- Commercialization of WRAPSODY CIE began in the US in January 2025.
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