Merit Medical Systems recently announced the enrolment of the first patients in its Wrapsody arteriovenous (AV) access efficacy pivotal (WAVE) study of the Wrapsody endovascular stent graft, an investigational device being studied for the treatment of stenosis or occlusion within dialysis outflow circuits. Jeffrey Hoggard (RAC Surgery Center, Raleigh, USA) successfully enrolled the first two subjects with venous outflow peripheral lesions.
“We are pleased to announce the first subjects enrolled into the Merit Medical WAVE study. Stent grafts have a proven track record in dialysis AV access, and we are excited to evaluate the Wrapsody stent fraft in our patients for this clinical trial,” said Hoggard.
Over two million patients with kidney disease worldwide receive haemodialysis. Preferred long-term vascular access in these patients is generally achieved by the surgical creation of an arteriovenous fistula (AVF) or implantation of an arteriovenous graft (AVG). Vascular access circuit dysfunction is a common complication over time in AVFs and AVGs, accounting for 20% of hospitalizations in end-stage renal disease patients. Stenosis or occlusion of these vascular access circuits is most common in the venous outflow segment.
The Wrapsody endovascular stent graft is an investigational device with an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene (ePTFE) and an internal layer of spun PTFE with an interposed non-porous fluoropolymer bonding layer.
The multicentre WAVE study comparing the Merit Wrapsody endovascular stent graft to percutaneous transluminal angioplasty (PTA) for treatment of venous outflow circuit stenosis or occlusion in haemodialysis patients plans to enrol 357 patients across multiple sites in the United States, Europe, Canada, and New Zealand. The study has been designed to include a population of 244 patients with AVFs and 113 with AVGs. Merit intends to randomize treatment in patients with AVFs to the Wrapsody stent graft or PTA and follow study subjects for two years postprocedure.
The WAVE study follows successful completion of the Wrapsody FIRST feasibility study which included 46 patients in Europe. The Wrapsody system previously received the CE mark and complements other vascular access products distributed by Merit, including the Hero graft and the Surfacer inside-out access catheter system.