Primary Endpoint Data From NEAT Presented for TVA's everlinQ endoAVF System

January 28, 2016—TVA Medical, Inc. announced that primary endpoint data from the Novel Endovascular Access Trial (NEAT) evaluating the company’s everlinQ endovascular arteriovenous fistula (endoAVF) system were presented by Charmaine E. Lok, MD, at LINC 2016, the Leipzig Interventional Course held January 26–29 in Leipzig, Germany. A live case demonstrating the use of the everlinQ endoAVF system was conducted at LINC by Arne Schwindt, MD, vascular surgeon at St. Franziskus Hospital in Muenster, Germany.

According to TVA, NEAT is a prospective, multicenter clinical study evaluating the safety and efficacy of the everlinQ endoAVF system, which uses catheter-delivered radiofrequency energy to create an AVF for hemodialysis access in vessels not traditionally used during surgery for patients with end-state kidney disease.

The NEAT primary endpoint data demonstrated that 91% of 60 study patients had a usable and unobstructed fistula within 3 months after the endoAVF procedure. In addition, the endoAVF procedure had a 98% success rate in creating an endoAVF. Follow-up will continue out to 12 months at six investigational sites in Canada and Australia.

Dr. Lok, who is Medical Director of the Hemodialysis Program, University Health Network-Toronto General Hospital in Canada, serves as Principal Investigator in the NEAT study. In the company’s press release, Dr. Lok commented, “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 AVF.” Dr. Lok presented preliminary NEAT results in November at VIVA 2015, the Vascular InterVentional Advances meeting in Las Vegas, Nevada.

The everlinQ endoAVF system has been studied outside the United States and has received European CE Mark approval. TVA Medical advised that it is not currently available in the United States and has not been evaluated by the US Food and Drug Administration.