Enrollment Begins in Merit Medical’s Wrapsody AV Access Efficacy Pivotal Study

March 11, 2021—Merit Medical Systems, Inc. announced that the first patients have been enrolled in the Wrapsody ArterioVenous (AV) Access Efficacy (WAVE) pivotal study of the company’s Wrapsody endovascular stent graft.

According to Merit Medical, the multicenter WAVE study is comparing the Wrapsody device to percutaneous transluminal angioplasty (PTA) for treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients. The study plans to enroll 357 patients at multiple sites in the United States, Europe, Canada, and New Zealand.

The study has been designed to include a population of 244 patients with AV fistulas and 113 with AV grafts. Merit intends to randomize treatment in patients with AV fistulas to the Wrapsody device or PTA and follow study subjects for 2 years postprocedure.

Jeffrey Hoggard, MD, from RAC Surgery Center LLC in Raleigh, North Carolina, enrolled the first two patients with venous outflow peripheral lesions.

“We are pleased to announce the first subjects enrolled into the Merit Medical WAVE study,” commented Dr. Hoggard in the company’s announcement. “Stent grafts have a proven track record in dialysis AV access, and we are excited to evaluate the Wrapsody stent graft in our patients for this clinical trial.”

Wrapsody is an investigational device being studied for the treatment of stenosis or occlusion within dialysis outflow circuits. The device features an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene and an internal layer of spun polytetrafluoroethylene with an interposed nonporous fluoropolymer bonding layer.

The WAVE study was preceded by the successful completion of the WRAPSODY FIRST feasibility study which included 46 patients in Europe. The Wrapsody system, which previously received European CE Mark approval, complements other vascular access products distributed by Merit, including the Hero graft, noted the company.