Merit Medical has today announced positive six-month findings from the randomized 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) annual congress (Sept. 14–18) in 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.
The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to Wrapsody or percutaneous transluminal angioplasty (PTA).
Merit shares in a press release that 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, an interventional radiologist at St. Joseph Heart and Vascular Center in Orange, California, 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, MD, an interventional radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, 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 randomized 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 hemodialysis treatment.”
Merit advises that the Wrapsody cell-impermeable endoprosthesis is not approved or available for commercial distribution in the U.S. 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 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 FDA for commercial use in the U.S. The device is available in Brazil and in the European Union.
