Monday, June 25, 2018
TVA Medical, Inc. today announced it has received U.S. Food and Drug Administration (FDA) De Novo marketing authorization of the everlinQ® endoAVF System. This innovative, minimally invasive technology uses magnetic catheters and radiofrequency energy to create an arteriovenous fistula (AVF) for hemodialysis access without open surgery.
"The everlinQ endoAVF System is a significant advance in the management of chronic kidney disease," said Paul Kreienberg, M.D., vascular surgeon at The Vascular Group, Albany Medical College, Albany Medical Center Hospital, Albany, N.Y. "Hundreds of thousands of Americans require vascular access for lifesaving dialysis, but until now this access has required open surgery that is accompanied by high failure rates and low patient satisfaction. The everlinQ endoAVF System is transforming vascular access using a minimally invasive approach, and I anticipate a high level of interest from both patients and physicians for this compelling endovascular solution."
More than 400,000 people in the U.S. receive hemodialysis multiple times a week for end-stage renal disease (ESRD)1. The current standard vascular access approach uses open surgery to create an AVF for dialysis. Surgical AVFs are associated with failure rates up to 60 percent2 and often require frequent revisions.3,4 When a surgical AVF procedure is effective, the fistula takes on average over four months to mature before dialysis can begin.1 In addition, vascular access creates concern and stress for many ESRD patients, including the threat of repeat procedures and disfigurement of the arm, with up to 30 percent of patients refusing fistula surgery.5
"Vascular access issues significantly hinder the delivery of adequate dialysis for patients, and there has been little innovation related to surgical fistula creation in more than 50 years," added Dr. Kreienberg. "The everlinQ endoAVF System is a significant new vascular access option for these patients."
The FDA marketing authorization enables use of the everlinQ endoAVF System as a Class II medical device in the ulnar artery and ulnar vein, to create an endoAVF for hemodialysis use in properly indicated patients. Data from four clinical studies using the everlinQ endoAVF System demonstrated 97 percent procedural success; 88 percent fistula maturation (suitable for dialysis) at three months; and 75 percent successful cannulation at six months with minimal need for re-intervention.
"FDA marketing authorization of the everlinQ endoAVF System is a monumental milestone for dialysis patients who now have an alternative AVF option," said Adam L. Berman, president and CEO of TVA Medical. "Thanks to extensive collaboration with the FDA, clinical study investigators and clinical advisors, we are thrilled to now partner with the U.S. vascular surgery and nephrology communities to offer an innovative endovascular fistula creation approach. Training will begin immediately at select U.S. vascular surgery centers, and a U.S. post-market study is scheduled to initiate before the end of the year."
The everlinQ endoAVF System was reviewed by the FDA through the De Novo premarket review pathway, a regulatory process for some new medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence. The everlinQ endoAVF System received European CE Mark in 2014 and Health Canada Medical Device License in 2016 for ESRD patients.
