Merit Medical Systems (Nasdaq:MMSI) announced today that it has obtained FDA premarket approval for the Wrapsody cell-impermeable endoprosthesis. With this approval, the company plans to commence U.S. commercialization in 2025.\n\nBased in South Jordan, Utah, Merit Medical created Wrapsody to enhance vessel patency over the long term for dialysis patients. It features a unique coating with a nitinol stent frame, enclosed by a stretchable polytetrafluoroethylene (PTFE) outer shell. This medical device includes an innovative “spun” PTFE inner-luminal layer crafted to limit platelet and fibrin accumulation. Its cell-impermeable layer prevents tissue migration or accumulation.\n\nAccording to Merit Medical, the nitinol frame boosts radial force, enhances compression resistance, and offers softened ends. These features allow the device to adapt to vessel contours, resist physiological pressures, and minimize strain on the vessel walls. The company’s goal is to tackle stenosis in hemodialysis patients in ways that, according to them, covered stents cannot.\n\nDr. Mahmood K. Razavi from the St. Joseph Heart and Vascular Center in Orange, California, noted that previous interventions for stenosis in AV fistulas or AV grafts often fall short of providing lasting clinical benefits and frequently necessitate multiple interventions. Razavi emphasizes that Wrapsody showed high patency rates and may set a new standard in patient care.\n\n”Throughout the past decade, Merit has focused on ensuring that the Wrapsody device supports physicians in achieving the best possible outcomes for patients,” expressed Fred P. Lampropoulos, chair and CEO of Merit Medical. “We take pride in designing and delivering such an innovative solution that has shown the highest efficacy to date.”
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