Austin, Texas-based TVA Medical Inc. has won the 2014 Innovations in Cardiovascular Interventions (ICI) Best Start-Up Innovation Award. The company received the honor for its everlinQ System, a catheter-based technology designed to create hemodialysis access for chronic kidney disease patients in a minimally-invasive procedure.
The everlinQ System is an investigational device that creates an AVF using a minimally-invasive approach. In the procedure, two thin, flexible magnetic catheters are inserted in an artery and vein in the arm. A small burst of radiofrequency energy is used to connect the artery and vein to create the fistula, and the catheters are removed. The procedure is designed to enable patients to use their AVF for hemodialysis within two months. Currently there are no other percutaneous hemodialysis AV fistula technologies approved for use anywhere in the world.
TVA Medical's everlinQ System was selected as the winner from more than 80 international companies in a rigorous peer-reviewed process by a panel of judges, according to three main criteria: the impact on novelty; impact on patient care; and business potential. As the winner, TVA Medical has been invited to present its everlinQ System innovation to physicians from around the world at EuroPCR 2015, a leading interventional cardiology meeting in May 2015.
"We developed the endovascular arteriovenous fistula approach after observing suboptimal results with current surgical AV fistulas for renal failure patients," said William E. Cohn, MD, co-founder of TVA Medical, professor of surgery at Baylor College of Medicine, cardiac surgeon and director of the Center for Technology and Innovation at Texas Heart Institute. "Our clinical studies to date show strong promise for a less-invasive approach, and we're gratified to receive this prestigious innovation award."
The feasibility of the everlinQ System was studied in the FLEX-1 study, a non-randomized, prospective clinical trial. The Novel Endovascular Access Trial (NEAT) clinical study, currently enrolling in Canada, Australia and New Zealand, is further evaluating the performance of the system. everlinQ has not been studied in the United States and has not been approved for commercial use by the United States Food and Drug Administration.
"Worldwide more than 2 million patients with chronic kidney failure require a vascular access to enable their connection to life-sustaining dialysis, but currently must undergo an invasive and often unreliable surgical procedure to receive this treatment," said Adam L. Berman, CEO of TVA Medical. "We are committed to continued clinical validation of the everlinQ System, and this ICI award provides substantiation that our technology is disruptive and important for patients."