Merit Medical(US:MMSI) Globenewswire·2025-03-25 13:25Core Insights - Merit Medical Systems, Inc. announced the upcoming publication of six-month results from the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial in Kidney International and the twelve-month results will be presented at the Society of Interventional Radiology's 50th Annual Scientific Meeting [1][2] Group 1: Trial Overview - The WAVE trial is a multicenter, international investigational device exemption (IDE) trial evaluating the safety and efficacy of the WRAPSODY CIE over two years, involving 245 hemodialysis patients with venous outflow stenosis [3] - The trial compares the WRAPSODY CIE treatment (n=122) against standard percutaneous transluminal angioplasty (PTA, n=123) [3] Group 2: Efficacy and Safety Results - At six months, the WRAPSODY CIE demonstrated a target lesion primary patency of 89.8% compared to 62.8% for PTA (p<0.0001) and an access circuit primary patency of 72.6% versus 57.9% for PTA (p=0.015) [6] - At twelve months, the WRAPSODY CIE maintained a target lesion primary patency of 70.1% compared to 41.6% for PTA (p<0.0001) and an access circuit primary patency of 58.1% versus 34.4% for PTA (p=0.0003) [6][9] - No significant difference in safety outcomes was observed between the WRAPSODY CIE and PTA [6] Group 3: Regulatory Approval and Commercialization - The WRAPSODY CIE received premarket approval (PMA) from the FDA in December 2024 and began commercialization in the U.S. in January 2025 [7] - The device has also received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil [7] Group 4: Company Background - Merit Medical Systems, Inc. was founded in 1987 and specializes in the development, manufacture, and distribution of proprietary medical devices for interventional, diagnostic, and therapeutic procedures [10] - The company employs approximately 7,400 people worldwide and has a sales force and clinical support team of over 800 individuals [10]