Merit Medical Systems announced today that the Wrapsody cell-impermeable endoprosthesis has received premarket approval from the US Food and Drug Administration (FDA). With this approval, a press release notes, Merit can begin commercialisation of the device in the USA in 2025.
The company details that Wrapsody is designed to extend long-term vessel patency in dialysis patients. “Preserving vascular access for dialysis patients is critical for them to maintain lifesaving treatment,” said Bart Dolmatch (Palo Alto Medical Foundation, Palo Alto, USA), who is credited as co-inventor of the Wrapsody device, in a Merit press release. “I believe the advancements that the Wrapsody device offers will translate to better outcomes for haemodialysis patients.”
The Wrapsody cell-impermeable endoprosthesis consists of a proprietary covering that features a nitinol stent frame enveloped by an expandable polytetrafluoroethylene (ePTFE) outer layer, an inner-luminal layer of novel “spun” PTFE designed to reduce platelet and fibrin formation, and a middle cell-impermeable layer designed to prevent transgraft tissue migration or accumulation. Merit claims that the nitinol frame provides enhanced radial force, compression resistance, and softened ends to help the device conform to vessels, withstand physiological compression, and reduce stress on vessel walls.
Results from the WRAPSODY WAVE pivotal trial demonstrated that arteriovenous (AV) fistula and AV graft patients receiving treatment with the Wrapsody device for dialysis outflow lesions achieved a target lesion primary patency of 89.8% and 82%, respectively, at six months. The primary patency of the entire access circuit at six months in patients with an AV fistula and AV graft were 72.6% and 68.8%, respectively.
“Historically, interventions for patients who experience a stenosis in their AV fistula or AV graft have not provided sustained clinical benefits and often require multiple reinterventions,” said Mahmood K Razavi (St Joseph Heart and Vascular Center, Orange, USA), co-principal investigator of the WAVE trial. “Results from the WAVE trial have demonstrated that the Wrapsody device is associated with high patency rates and is likely to become the new standard of care.”
“Over the past decade, Merit has worked to ensure that the Wrapsody device helps physicians achieve the best possible outcomes for patients,” said Fred P Lampropoulos, Merit’s chairman and chief executive officer. “We are proud to design and deliver such an innovative solution that has demonstrated the highest efficacy to date.”
