Merit Medical(US:MMSI) Globenewswire·2025-11-05 14:00Core Insights - Merit Medical Systems, Inc. announced positive results from the randomized AVF arm of the WAVE trial, showcasing the effectiveness of the WRAPSODY CIE device in restoring vascular access for hemodialysis patients [1][4]. Company Overview - Merit Medical Systems, Inc. is a leader in healthcare technology, focusing on the development, manufacture, and distribution of proprietary medical devices for interventional, diagnostic, and therapeutic procedures [13]. - The company employs approximately 7,400 people globally and serves hospitals worldwide with a dedicated sales force and clinical support team [13]. Product and Trial Details - The WRAPSODY CIE is designed to restore vascular access in patients undergoing hemodialysis who face obstructions in their veins [2][6]. - The WAVE trial involved 245 hemodialysis patients treated with either the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA) across 43 centers in the U.S., South America, and the U.K. [3][4]. - Results showed that 24 months post-treatment, the target lesion primary patency (TLPP) was significantly higher for the WRAPSODY CIE group at 48.6% compared to 29.8% for PTA (p<0.0001), and access circuit primary patency (ACPP) was also higher at 31.3% versus 20.6% (p=0.003) [4][9]. Regulatory Approvals - The WRAPSODY CIE received premarket approval from the U.S. FDA on December 19, 2024, and was subsequently 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]. Ongoing Research and Registries - 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]. - The WRAP Global registry is also assessing real-world outcomes outside of North America [8]. - Data from the WAVE trial and these registries will provide evidence on the largest cohort of patients for a single indication in dialysis access to date [10].