Novel Hemodialysis Access System Demonstrates High Suitability For Dialysis In Clinical Trial

LEIPZIG, Germany, Jan. 28, 2016 /PRNewswire/ -- TVA Medical, Inc., announced primary endpoint data from a prospective, multicenter clinical study evaluating the everlinQ™ endoAVF System. This novel medical technology creates an arteriovenous (AV) fistula for hemodialysis 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 U.S. Food and Drug Administration.

NEAT primary endpoint data were presented today at the Leipzig Interventional Course (LINC) 2016 in Leipzig, Germany, demonstrating that 91 percent 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 percent) 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, MD, FRCPC, Medical Director of the Hemodialysis Program, University Health Network- Toronto General Hospital in 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 today, conducted by Arne Schwindt, MD, vascular surgeon at St. Franziskus Hospital in Muenster, Germany.

Worldwide, over 2 million people with end stage kidney failure receive hemodialysis therapy and require vascular access to connect their blood circulation to a dialysis machine.¹ Surgical AV fistulas are currently the preferred approach to achieve vascular access but are associated with high failure rates, often as high as 60 percent.^2,3

"We are pleased to share these positive primary endpoint results and to demonstrate a live case using our technology at LINC," said 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."

About the everlinQ endoAVF System
The everlinQ endoAVF System is designed to create an AV fistula for hemodialysis access using an endovascular approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small amount of radiofrequency energy is used to connect the artery and vein to create the fistula, and the catheters are removed.

About TVA Medical
TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage kidney disease and other potential applications, including a catheter-based AV fistula system. More information is available at www.TVAMedical.com

¹ Liyanage et al. Lancet.10.1016/S0140-6736.
² Al-jaishi, et al.  Am J Kidney Dis 2014;63:464-78.
³ Lok. Clin J Am Soc Nephrol 2: 1043-1053, 2007.

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SOURCE TVA Medical, Inc.