Core Insights - Merit Medical Systems, Inc. announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial, showcasing the performance of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) for patients with advanced kidney disease undergoing hemodialysis [1][5][6] Group 1: Trial Overview - The WAVE trial aimed to evaluate the performance of the WRAPSODY CIE in restoring functional vascular access in patients with complications such as stenosis or occlusion [3] - The trial involved 43 centers across the United States, South America, and the United Kingdom [3] Group 2: Efficacy Results - In the non-randomized arm of the WAVE trial, 112 patients were treated with the WRAPSODY CIE, achieving a target lesion primary patency (TLPP) of 81.4% at 6 months, exceeding the established performance goal of 60% [4] - The TLPP at 12 months was 60.2%, and at 24 months, it was 41.7% [4][10] - The access circuit primary patency (ACPP) at 12 months was 36.2%, and at 24 months, it was 25.7% [4][10] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the US FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [6] - The device has also received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil [6] Group 4: Future Research - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [8]