TVA Medical, Inc., announced clinical trial results from a prospective, multicenter clinical study evaluating the everlinQTM endoAVF System. This innovative medical technology creates hemodialysis access using vascular sites not traditionally used by surgeons for people with end-stage kidney disease (ESKD).
The Novel Endovascular Access Trial (NEAT) is evaluating the safety and efficacy of the everlinQ endoAVF System to create an endovascular arteriovenous fistula (AVF) – or an endoAVF – for dialysis access using radiofrequency energy. The system has been studied outside the United States and has CE marking. It is not currently available in the United States and has not been evaluated by the U.S. Food and Drug Administration.
Early NEAT results were presented today during a session of "late-breaking important information and key updates" at VEITHsymposium by study Principal Investigator Charmaine E. Lok, MD, FRCPC, Senior Scientist at the Toronto General Hospital Research Institute and Medical Director of the Hemodialysis Program, University Health Network-Toronto General Hospital in Toronto, Ontario, Canada.
Nine participating sites in Canada, Australia and New Zealand showed that the everlinQ endoAVF System had high success (98%) in creating an endoAVF in 59 of 60 patients. Early one-month ultrasound findings suggest that the endoAVFs may be physiologically suitable for dialysis.
"Chronic kidney disease patients who require a hemodialysis AV fistula currently do not have an endovascular option for its creation," said Dr. Lok. "The early results from NEAT showing high procedure success in creating endoAVFs are exciting. We look forward to sharing longer-term clinical results using this innovative technique."
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. 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.
"The need is significant for a simple, effective hemodialysis AV fistula access option," said Adam L. Berman, president & chief executive officer of TVA Medical. "We look forward to continuing our everlinQ endoAVF global clinical research program, with hopes of delivering a solution in the future to help meet this unmet need."
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