Merit Medical Systems has received premarket approval from the US Food and Drug Administration (FDA) for its WRAPSODY Cell-Impermeable Endoprosthesis.
This approval allows Merit Medical Systems to commercialise the device in the US starting in 2025, said the Utah–based healthcare technology manufacturer.
WRAPSODY has been designed to improve long-term vessel patency in dialysis patients. These patients often depend on vascular access sites like arteriovenous (AV) fistulas or AV grafts, which are soft tubes placed in the arm.
Merit Medical said that maintaining proper blood flow through these sites is essential for survival. However, complications like stenosis, which is narrowing of blood vessels, and thrombosis, which is blood clot formation, can threaten patient health over time.
The WRAPSODY Cell-Impermeable Endoprosthesis features a proprietary design with a nitinol stent frame surrounded by an expandable polytetrafluoroethylene (PTFE) outer layer. It has a spun PTFE inner-luminal layer that helps reduce platelet and fibrin formation.
Additionally, the device has a middle cell-impermeable layer that prevents transgraft tissue migration or accumulation.
The nitinol frame enhances radial force, improves compression resistance, and softens the ends, allowing the device to conform to vessels, survive physiological compression, and minimise stress on vessel walls.
Merit Medical Systems chairman and CEO Fred Lampropoulos said: “Over the past decade, Merit has worked to ensure that the WRAPSODY device helps physicians achieve the best possible outcomes for patients.
“We are proud to design and deliver such an innovative solution that has demonstrated the highest efficacy to date.”
Results from the WRAPSODY WAVE trial showed promising outcomes for dialysis patients using the WRAPSODY Cell-Impermeable Endoprosthesis device. The results from the AV grafts cohort were announced last month.
In the study, AV fistula patients treated with the WRAPSODY device for dialysis outflow lesions achieved a primary lesion patency of 89.8% at six months, while AV graft patients achieved 82%.
The primary patency of the entire access circuit at six months was 72.6% for AV fistula patients and 68.8% for AV graft patients.
In June this year, Medtronic expanded its partnership with Merit Medical to offer steerable balloon catheters for vertebral compression fractures (VCF) treatment in the US.
