The WAVE trial is being conducted under an investigational device exemption granted by the US Food and Drug Administration (FDA). Image credit: Shutterstock/Christoph Burgstedt.

Merit Medical has revealed positive six-month data from a trial investigating its endoprosthesis in dialysis patients who require an arteriovenous fistula (AVF).  

The results, which were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), demonstrate that the US company’s device led to an 89.9% target lesion primary patency at six months.

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Merit Medical’s device, named WRAPSODY, is a cell-impermeable stent graft designed to extend long-term vessel patency in dialysis patients. AVFs are abnormal connections created between arteries and veins for dialysis access. For patients undergoing multiple haemodialysis procedures, repeated blockages can occur.

The WRASODY arteriovenous access efficacy (WAVE) trial enrolled 245 patients, with patients either receiving Merit’s treatment or percutaneous transluminal angioplasty (PTA), the standard-of-care.

Merit reported that target lesion primary patency in patients treated with WRAPSODY was 27 percentage points higher than in patients within the PTA cohort.

The WAVE trial is being conducted under an investigational device exemption granted by the US Food and Drug Administration (FDA).

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Merit stated: “Findings from the WAVE study expand on results from the first-in-human study (WRAPSODY FIRST) and support the Premarket Approval (PMA) application to the FDA for commercial use in the United States.”

Previously, results from a 45-patient first-in-human study, which were published in the Journal for Vascular Surgery, demonstrated a target lesion primary patency of 100% and 84.6% at 30 days and 365 days respectively.

Whilst the innermost layer of the WRAPSODY is made of a biocompatible polytetrafluoroethylene layer, the outer layer is engineered with biocompatible expanded polytetrafluoroethylene. The inner layer reduces fibrin deposition and thrombus formation, and an impermeable middle graft layer is designed to prevent transmural cellular migration.  The outer layer allows for tissue ingrowth to prevent stent migration.

WAVE’s co-principal investigator Mahmood K. Razavi said: “The superiority of the six-month efficacy data is compelling and provides clinicians the chance to evaluate how WRAPSODY can help us prolong the vascular access of our patients. WRAPSODY should be the new standard of care for these patients.”

Also in the AVF space is Concept Medical which won an investigational device exemption (IDE) for its MagicTouch system. Concept Medical has designed a sirolimus-coated balloon to treat the lesions.