Primary endpoint data from a prospective, multicentre clinical study evaluating the everlinQ endoAVF system have been announced by TVA Medical. The system is designed to an arteriovenous (AV) fistula for haemodialysis access in people with end-state kidney disease (ESKD) using an endovascular approach in vessels not traditionally used during surgery.
The Novel Endovascular Access Trial (NEAT) is evaluating the safety and efficacy of the everlinQ endoAVF system to create an endovascular AV fistula (endoAVF) for dialysis access using catheter-delivered radiofrequency energy. The everlinQ endoAVF system has been studied outside the United States and is CE marked. It is not currently available in the United States and has not been evaluated by the US Food and Drug Administration.
NEAT primary endpoint data were presented at the Leipzig Interventional Course (LINC) 2016 in Leipzig, Germany, demonstrating that 91% of 60 study patients had a usable and unobstructed fistula within 3 months following the endoAVF procedure. In addition, the endoAVF procedure was highly successful (98%) in creating an endoAVF. Study follow-up is ongoing out to 12 months at six investigational sites in Canada and Australia.
According to presenter Charmaine E Lok, medical director of the Hemodialysis Program, University Health Network-Toronto General Hospital, Canada, and principal investigator in the NEAT study, “This first look at positive primary endpoint data provides promise to clinicians that the everlinQ endoAVF system may be an alternative to the traditional surgical AV fistula.”
A live case demonstrating the use of the everlinQ endoAVF system was presented at LINC, conducted by Arne Schwindt, vascular surgeon at St. Franziskus Hospital in Muenster, Germany.
“We are pleased to share these positive primary endpoint results and to demonstrate a live case using our technology at LINC,” says Adam L Berman, president & chief executive officer of TVA Medical. “We look forward to completing the NEAT study later this year, to further illustrate the potential long-term benefits of the everlinQ endoAVF System for patients with end-state kidney disease.”