Core Insights - The Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) demonstrated a 60.2% target lesion primary patency (TLPP) at 12 months in the AVG cohort of the WAVE trial [1] - The WAVE trial's single-arm cohort included 112 patients, achieving a 6-month TLPP of 81.4%, exceeding the performance goal of 60% by 21.4 percentage points [2] - The safety performance goal was surpassed, with 95.4% of AVG patients free from adverse events compared to the goal of 89.0% [2] - Access circuit primary patency (ACPP) at 6 months was 69.2% and at 12 months was 36.2% [2] - Previous findings from the randomized arm of the WAVE trial indicated a TLPP of 70.1% and ACPP of 58.1% at 12 months [4] Company Overview - Merit Medical Systems, Inc. specializes in the development, manufacture, and distribution of proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures [6] - The company has a global presence, serving client hospitals with a sales force and clinical support team of over 800 individuals and employing approximately 7,300 people worldwide [6] - The WRAPSODY CIE is currently available in Brazil and the European Union, and it is approved for commercial distribution in the United States [5]
Merit Medical Releases 12-Month Efficacy Results for the Single-Arm Arteriovenous Graft (AVG) Cohort of the WRAPSODY® Arteriovenous Efficacy (WAVE) Trial