Merit Medical releases 12-month efficacy results of WRAPSODY WAVE cohort

Merit Medical (MMSI) Systems announced that the 12-month results from the single-arm cohort of the WAVE trial were presented at the annual Charing Cross Symposium held in London, England, on April 23, 2025, during the Vascular Access Masterclass session. Following the scientific podium presentation, results were presented during a Merit-sponsored symposium. The single-arm cohort of the WAVE trial included 112 patients with an AVG who were treated with the WRAPSODY CIE device. The primary efficacy measure, 6-month TLPP, was compared to an efficacy performance goal for covered stents. At 6 months, the TLPP associated with the WRAPSODY CIE was 81.4%, a result 21.4 percentage points higher than the performance goal of 60%. The proportion of AVG patients who were free from an adverse event was higher than the safety performance goal. At 12 months, the TLPP associated with the WRAPSODY CIE was 60.2%. Access circuit primary patency at 6 and 12 months were 69.2% and 36.2%, respectively. “Patients with a failing AVG have limited options available to restore functionality of their access,” said Robert G. Jones, MBChB, FRCR, Consultant Interventional Radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, and Co-Principal Investigator of the WAVE trial. “Therefore, it was exciting to present findings to my colleagues, so they are aware of WRAPSODY’s potential to improve care for this vulnerable patient population.”