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 experiencing vascular access obstructions [1][2][5] 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 face obstructions in their vascular access [2][4] - The study will evaluate clinical outcomes over a three-year period for patients treated with the WRAPSODY CIE [2][4] - The first patient was enrolled by Dr. Omar Davis, highlighting the importance of this registry in assessing the device's effectiveness [2][3] Group 2: WRAPSODY CIE Device - The WRAPSODY CIE has shown superior performance in previous clinical trials, specifically the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial [3][4] - The WAVE trial compared outcomes of patients treated with WRAPSODY CIE versus those treated with percutaneous transluminal angioplasty (PTA) [3] - The WRAPSODY CIE received premarket approval from the FDA on December 19, 2024, and was subsequently approved by Health Canada on April 30, 2025 [7] Group 3: Future Prospects - The WRAP North America registry aims to contribute to a growing portfolio of clinical evidence supporting the WRAPSODY CIE, potentially representing the largest cohort of patients treated with an implantable device for vascular access restoration [4][5] - A parallel WRAP Global registry is also being conducted to evaluate real-world outcomes, with an expected final enrollment of up to 500 patients outside North America by the end of 2025 [5][6]