Merit Medical has announced that it has completed enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomized, controlled, multicenter study comparing the Merit WRAPSODY cell-impermeable endoprosthesis (CIE) to percutaneous transluminal angioplasty (PTA) for treatment of stenosis/occlusion in the venous outflow circuit in patients undergoing hemodialysis.
Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access is required for patients undergoing hemodialysis. However, progressive stenosis and/or occlusion of blood vessels where the AVF and AVG are located can prevent delivery of hemodialysis, which can have life-threatening consequences. WRAPSODY was developed to help physicians treat patients with stenosis/occlusion in the vessels used for hemodialysis.
The WAVE study enrolled 244 patients with AVFs and 113 patients with AVGs across sites in Brazil, Canada, the UK, and the USA. Merit intends to collect safety and efficacy outcomes throughout the study follow-up period. Merit anticipates filing primary outcomes with the US. Food and Drug Administration (FDA) for premarket approval (PMA) after six months post-enrollment completion. Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrollment.
