TVA Medical has announced clinical trial results from a prospective, multicentre clinical study evaluating the everlinQ endovascular arteriovenous fistula system. This medical technology creates haemodialysis access using vascular sites not traditionally used by surgeons for people with end-stage kidney disease.
The Novel Endovascular Access Trial (NEAT) is evaluating the safety and efficacy of the everlinQ system to create an endovascular arteriovenous fistula for dialysis access using radiofrequency energy. The system has been studied outside the USA and has CE marking. It is not currently available in the USA and has not been evaluated by the US Food and Drug Administration.
Early NEAT results were presented during a late-breaking session at the VEITHsymposium (17–21 November, New York, USA) by principal investigator Charmaine E Lok, 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 system had high success (98%) in creating an endovascular arteriovenous fistula in 59 of 60 patients. Early one-month ultrasound findings suggest that the fistula may be physiologically suitable for dialysis.
“Chronic kidney disease patients who require a haemodialysis endovascular arteriovenous fistula currently do not have an endovascular option for its creation,” said Lok. “The early results from NEAT showing high procedure success in creating endovascular arteriovenous fistula 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 haemodialysis therapy and require vascular access to connect their blood circulation to a dialysis machine. Surgical endovascular arteriovenous fistula are currently the preferred approach to achieve vascular access but are associated with high failure rates, often as high as 60%.