Merit Medical Systems has received premarket approval from the US Food and Drug Administration (FDA) for its WRAPSODY Cell-Impermeable Endoprosthesis allowing the company to commercially launch the device next year in the US.
Engineered to maintain long-term vessel patency, which is vital for patients undergoing dialysis treatments, the device is a response to the critical need for maintaining adequate blood flow through arteriovenous (AV) fistula and AV graft sites in individuals with dialysis.
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Merit researchers developed the device in 2010 in partnership with interventional radiologist Dr Bart Dolmatch at Palo Alto Medical Foundation.
The device features a nitinol stent frame and a multi-layered polytetrafluoroethylene (PTFE) covering, including an inner-luminal layer to decrease platelet and fibrin formation and a cell-impermeable layer to avert migration of the tissue.
Dolmatch said: “Preserving vascular access for dialysis patients is critical for them to maintain lifesaving treatment.
“I believe the advancements that the WRAPSODY device offers will translate to better outcomes for haemodialysis patients.”
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By GlobalDataThe nitinol frame is tailored to offer radial force, softened ends, and compression resistance to ensure the device conforms to vessels withstands physiological compression, and minimises stress on vessel walls.
Clinical trial outcomes from the WRAPSODY WAVE pivotal trial demonstrated that subjects with AV fistula and AV graft treated with the device for dialysis outflow lesions achieved a target lesion primary patency of 89.8% and 82%, at a six-month period, respectively.
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.”
The company reported the six-month data from the WAVE trial in September this year.
Moreover, the primary patency of the entire access circuit at six months was 72.6% for AV fistula patients and 68.8% for those with an AV graft.
