With approval, the company can begin commercializing the device in the U.S. in 2025.
South Jordan, Utah–based Merit Medical designed Wrapsody to extend long-term vessel patency in dialysis patients. It consists of a proprietary covering that features a nitinol stent frame enveloped by an expandable polytetrafluoroethylene (PTFE) outer layer. The device has an inner-luminal layer of novel “spun” PTFE designed to reduce platelet and fibrin formation. Its middle cell-impermeable layer prevents transgraft tissue migration or accumulation.
Merit Medical said the nitinol frame provides enhanced radial force, compression resistance and softened ends. This helps the device conform to vessels, withstand physiological compression and reduce stress on the vessel walls. The company aims to address stenosis in hemodialysis patients in ways it says covered stents can’t.
Dr. Mahmood K. Razavi of the St. Joseph Heart and Vascular Center in Orange, California, said previous interventions for patients with a stenosis in their AV fistula or AV graft failed to provide sustained clinical benefits. Additionally, they often require multiple re-interventions. Razavi says Wrapsody demonstrated high patency rates and could become a 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 Medical chair and CEO. “We are proud to design and deliver such an innovative solution that has demonstrated the highest efficacy to date.”
