Merit Medical has today announced positive six-month findings from the randomised arteriovenous (AV) fistula arm of its Wrapsody Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE: 14–18 September, Lisbon, Portugal) during a FIRST@CIRSE presentation.
Wrapsody is a cell-impermeable endoprosthesis which is intended to extend long-term vessel patency in dialysis patients. Many patients undergoing dialysis rely on a vascular access site created in the arm called an AV fistula. The maintenance of adequate blood flow through this site is crucial for patient survival.
The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomised 1:1 to Wrapsody or percutaneous transluminal angioplasty (PTA). Target lesion primary patency in patients treated with Wrapsody was 27 percentage points higher than patients in the PTA cohort (89.8% vs. 62.8%, p<0.0001). The proportion of patients who experienced an adverse event was similar between cohorts.
“The superiority of the six-month efficacy data is compelling and provides clinicians the chance to evaluate how Wrapsody can help us prolong the vascular access of our patients. Wrapsody should be the new standard of care for these patients,” said Mahmood K Razavi (St. Joseph Heart and Vascular Center, Orange, USA), co-principal investigator of the WAVE trial. “Meeting with colleagues at CIRSE to discuss the AV fistula arm of the WAVE study was the first of what we hope to be many productive discussions,” said Robert G Jones (Queen Elizabeth Hospital Birmingham, Birmingham, UK), and co-principal investigator of the WAVE study. “The potential for Wrapsody to help us safely extend vascular access for our patients is a vital component of care.”
“The data release of positive findings from the randomised AV fistula arm of the WAVE study marks a major milestone for Merit,” said Fred P Lampropoulos, Merit’s chairman and chief executive officer (CEO). “This is an important next step in our continued efforts to seek ways to improve care for patients requiring haemodialysis treatment.”
The Merit Wrapsody Cell-Impermeable endoprosthesis is not approved or available for commercial distribution in the USA and may not be approved or available for sale or use in other countries. In the USA, the device is being used under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). Findings from the WAVE study expand on results from the first-in-human study (Wrapsody FIRST) and support the Premarket Approval (PMA) application to the US FDA for commercial use in the USA. The device is available in Brazil and in the European Union.
