TVA Medical Wins Innovation Award For Minimally Invasive Hemodialysis Access System

AUSTIN, Texas, Jan. 19, 2015 /PRNewswire/ -- TVA Medical, Inc., today announced it has won the 2014 Innovations in Cardiovascular Interventions (ICI) Best Start-Up Innovation Award. The company received the top international honor for its everlinQ^TM System, a catheter-based technology designed to create hemodialysis access for chronic kidney disease patients in a minimally-invasive procedure. The investigational technique has the potential to revolutionize how patients with chronic kidney failure receive ongoing hemodialysis. Today, dialysis patients typically receive open vascular surgery that often requires repeat procedures in order to be connected to the dialysis machine.

The ICI Innovation Award is the world's most prestigious award for cardiovascular start-up companies. 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 (AVF) approach after observing suboptimal results with current surgical AV fistulas for renal failure patients," said William E. Cohn, M.D., 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."

About Traditional Vascular Access
The standard approach to achieve vascular access for hemodialysis is the creation of an AVF. It is performed by sewing a vein to a nearby artery in the arm to create a blood vessel with high flow for dialysis.  AVFs have failure rates as high as 60 percent¹ and require frequent revision procedures, resulting in increased morbidity and high costs to the healthcare system.

Patients receiving surgical AVFs require an average of two to three additional procedures to achieve a usable fistula², which can delay usability of the AVF for hemodialysis by five to 12 months³. In addition to common surgical AVF complications, the cost to the healthcare system of managing dysfunctional vascular access is high – estimated at approximately $2.9 billion annually in the United States alone⁴.

About the everlinQ System
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 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.

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

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SOURCE TVA Medical, Inc.

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