Merit Medical releases efficacy results from single-arm AVG cohort of WAVE trial

Merit Medical (MMSI) Systems announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial. Results of the AVG cohort were presented during the Late-Breaking Clinical Trials session at the annual VIVA Foundation Venous Endovascular Interventional Strategies conference held in Las Vegas, NV. For the millions of patients diagnosed with advanced kidney disease, hemodialysis is a life-saving treatment that replaces the function of the kidneys. The administration of hemodialysis requires ongoing vascular access that is commonly achieved through the surgical creation of an AVG in a central or peripheral vein. However, complications, such as stenosis or occlusion, in the patient veins required for vascular access are common. The WRAPSODY Cell-Impermeable Endoprosthesis is intended to help physicians restore vascular access in patients on hemodialysis who experience these complications. The WAVE trial was designed to capture the performance of the WRAPSODY CIE. TLPP and ACPP outcomes were used to evaluate the ability of the device to restore functional vascular access in trial patients. Forty-three centers across the United States, South America, and the United Kingdom participated in the trial. In the non-randomized arm of the WAVE trial, 112 patients with a stenosis or occlusion in their AVG were treated with the WRAPSODY CIE. The TLPP at 6 months was compared to historical outcomes and then documented over 24 months. The TLPP at 6 months exceeded the established performance goal. At 12 and 24 months, the TLPP for patients treated with the WRAPSODY CIE were 60.2% and 41.7%, respectively. At 12 and 24 months, the ACPP for patients treated with the WRAPSODY CIE were 36.2% and 25.7%, respectively. “The ability of the WRAPSODY CIE to offer patients with a failing AVG the opportunity to extend vascular access is promising; the 24-month efficacy results will be of the utmost importance to physicians,” said Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, CA, and Co-Global Principal Investigator of the WAVE trial. Dr. Razavi presented results from the non-randomized arm of the trial at the VEINS conference.