Merit Medical has announced that is has completed enrolment in its WRAPSODY arteriovenous access efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomised, controlled, multicentre 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 haemodialysis.
Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access is required for patients undergoing haemodialysis. However, progressive stenosis and/or occlusion of blood vessels where the AVF and AVG are located can prevent delivery of haemodialysis, which can have life-threatening consequences. WRAPSODY was developed to help physicians treat patients with stenosis/occlusion in the vessels used for haemodialysis.
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-enrolment completion. Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrolment.
“Given the inadequacy of therapeutic options to maintain vascular access in haemodialysis patients, understanding WRAPSODY’s overall performance—due to its unique cell-impermeable stent covering in helping to maintain AV fistulas and grafts—is of high value to physicians and the scientific community,” says Mahmood K Razavi, medical director of clinical research at St Joseph Heart and Vascular Center (Orange, USA), co-principal investigator of the WAVE study, and paid consultant of Merit.
“The WAVE study has now completed the anticipated recruitment thanks to the patients that participated and to the hard work of all the global investigators and their respective teams,” says Rob Jones, consultant interventional radiologist at Queen Elizabeth Hospital Birmingham (Birmingham, England), co-principal investigator of the WAVE study, and paid consultant of Merit. “I am looking forward to the data analysis and the next step in this device’s journey in providing definitive management to AV access patients.”
“Enrolment of the last patients in the WAVE study represents an important milestone,” says Fred P Lampropoulos, Merit’s chairman and CEO. “We believe it will enable us to provide critical insight to our physician partners and support our submission of a PMA application to the Food and Drug Administration.”