Merit’s Wrapsody CIE Evaluated in 12-Month Efficacy Data From WAVE

March 25, 2025—Merit Medical Systems, Inc. announced the publication of the 6-month results from the randomized arm of the WAVE trial of arteriovenous access efficacy of the company’s Wrapsody cell-impermeable endoprosthesis (CIE). The Wrapsody CIE is designed to help restore vascular access in patients on hemodialysis who experience stenosis in their venous outflow circuit. The findings were published by Mahmood K. Razavi, MD, et al in Kidney International (2025;107:740-750).

According to Merit, the WAVE trial is a multicenter, international, investigational device exemption trial designed to evaluate the Wrapsody CIE’s safety and efficacy over 2 years. In the randomized arm of the trial, 245 patients on hemodialysis who experienced stenosis in the venous outflow of their arteriovenous fistula were treated with the Wrapsody CIE (n = 122) or standard percutaneous transluminal angioplasty (PTA, n = 123).

The company noted that treatment efficacy was defined as the proportion of patients who did not require intervention because of clinically driven target lesion revascularization or target lesion thrombosis (target lesion primary patency). 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 (access circuit primary patency).

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. As summarized in Merit’s press release, initial results at 6 months demonstrated that the target lesion primary patency was significantly higher for the Wrapsody CIE versus PTA (89.8% vs 62.8%; P < .0001). Similarly, the access circuit primary patency was significantly higher for the Wrapsody CIE versus PTA (72.6% vs 57.9%; P = .015). No significant difference in the safety outcome was observed between treatments.

At 12 months, both target lesion primary patency (70.1% vs 41.6%; P < .0001) and access circuit primary patency (58.1% vs 34.4%; P = .0003) remained significantly higher for the Wrapsody CIE than PTA. The company advised that the 12-month results from the randomized arm of the WAVE trial are scheduled to be presented on March 30, 2025, during the late-breaking trials session at SIR 2025, the Society of Interventional Radiology’s 50th annual scientific meeting held March 29 to April 2 in Nashville, Tennessee.

“The Wrapsody CIE’s positive outcomes at 1 year address an important knowledge gap regarding the potential durability of the device,” commented WAVE investigator Dheeraj K. Rajan, MD, in Merit’s press release. Dr. Rajan, who is Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, continued, “It is encouraging to know there is a new device available to help us prolong functional vascular access in our patients.”

In December 2024, Merit announced FDA premarket approval for the Wrapsody CIE. The company began commercialization of the device in the United States in January 2025. The device previously received CE Mark approval for commercial use in the European Union and is available in Brazil.