First Patient Enrolled in Merit Medical's WRAPSODY (WRAP) North America Registry

Core Insights - Merit Medical Systems, Inc. has successfully enrolled the first patient in the WRAP North America registry, aimed at evaluating the WRAPSODY Cell-Impermeable Endoprosthesis (CIE) for patients on hemodialysis [1][5][8] Group 1: WRAP North America Registry - The WRAP North America registry is designed to enroll up to 250 patients in the US and Canada who are on hemodialysis and experience vascular access obstructions [2][4] - The registry will evaluate clinical outcomes over three years for patients treated with the WRAPSODY CIE [2][4] - The first patient was enrolled by Dr. Omar Davis at Bluff City Vascular, marking a significant milestone for the company [2][5] Group 2: WRAPSODY CIE Device - The WRAPSODY CIE aims to restore vascular access for hemodialysis patients facing obstructions, with promising results demonstrated in the previous WAVE pivotal trial [3][4] - The WAVE trial compared the WRAPSODY CIE with percutaneous transluminal angioplasty (PTA) and historical outcomes of patients treated with previous-generation covered stents [3] - The device received premarket approval from the FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [7] Group 3: Clinical Evidence and Future Prospects - The WRAP North America registry is expected to contribute to a growing portfolio of clinical evidence supporting the WRAPSODY CIE [4] - A parallel WRAP Global registry is also being conducted to enroll up to 500 patients outside North America, with final enrollment expected by the end of 2025 [5] - The company emphasizes the importance of real-world effectiveness data to address critical questions regarding the device's broader impact in clinical practice [4][5]