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

Merit Medical (MMSI) Systems announced that the six-month results from the randomized arm of the WRAPSODY Arteriovenous Access Efficacy trial are scheduled for publication in the April issue of Kidney International. Twelve-month results from the randomized arm of the WAVE trial are scheduled for presentation at the Society of Interventional Radiology’s 50th Annual Scientific Meeting in Nashville, TN. The podium presentation is scheduled for March 30, 2025, during the late-breaking trials session. The creation of an arteriovenous fistula to achieve long-term access to blood vessels is required for patients undergoing hemodialysis. However, narrowing of blood vessels in and around the AVF can interfere with hemodialysis delivery, resulting in potentially life-threatening consequences. The WRAPSODY CIE is designed to help clinicians restore vascular access in patients on hemodialysis who experience stenosis in their venous outflow circuit. The WAVE trial is a multicenter, international, investigational device exemption trial designed to evaluate the WRAPSODY CIE’s safety and efficacy over two years. In the randomized arm of the trial, 245 patients on hemodialysis who experienced stenosis in the venous outflow of their AVF were treated with the WRAPSODY CIE or standard percutaneous transluminal angioplasty. Treatment efficacy was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis. An additional efficacy endpoint was the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access. Primary safety was defined as the proportion of patients with safety events that negatively affected the vascular access or venous outflow circuit, excluding target lesion revascularization or thrombosis, which resulted in reintervention, hospitalization, or death. Initial results at six months demonstrated that the target lesion primary patency was significantly higher for the WRAPSODY CIE vs. PTA. Similarly, the access circuit primary patency was significantly higher for the WRAPSODY CIE vs. PTA. No significant difference in the safety outcome was observed between treatments. At 12 months, the WRAPSODY CIE remained significantly higher than PTA for both target lesion primary patency and access circuit primary patency.