New Data Demonstrate Quality-Of-Life Improvements And Cost Savings For Endovascular Hemodialysis Access Vs. Traditional Open Surgery

BALTIMORE, May 23, 2018 /PRNewswire/ -- A healthcare analysis presented today shows that a novel, catheter-based endovascular system for creating hemodialysis access offers important quality-of-life benefits and cost savings compared to the traditional surgical approach in end-stage renal disease (ESRD) patients. The retrospective analysis comparing the everlinQ^® endoAVF System from TVA Medical, Inc. with surgical arteriovenous fistula (AVF) creation was presented today at ISPOR 2018, the leading global conference for health economics and outcomes research.

Compared to surgical AVF patients, endoAVF patients had nearly double the number of days with a functioning AVF for dialysis; spent less time using a central venous catheter (83 vs. 261 days), leading to improvements in quality-adjusted life years (QALYs) (0.574 QALYs vs. 0.548 QALYs), and needed fewer interventions (0.55 vs. 4.38), resulting in an average of 90 percent lower related costs ($1,271 vs. $13,031) in the first year after receiving an AVF.

"Over 7 percent of the Medicare budget is spent on managing patients with ESRD. Non-functional AVFs lead to prolonged central venous catheter use, increasing the risk of infection and hospitalization and contributing to the rising costs of treating hemodialysis patients. Procedures that facilitate a functional AVF, improve patient outcomes and save costs are an important advancement for patients and payers," said Adam L. Berman, CEO, TVA Medical, Inc. "We are encouraged by the results of this analysis and the benefit for patients."

The retrospective analysis compared endoAVF patients from the Novel Endovascular Access Trial (NEAT, NCT02036671) with propensity-score matched surgical AVF patients from the U.S. Renal Data System for one year after AVF creation.

More than 400,000 people in the U.S. receive lifesaving hemodialysis multiple times a week. Approximately 3 million people worldwide with ESRD are treated with hemodialysis each year.¹

About the everlinQ endoAVF System
The everlinQ endoAVF System is designed to create an AVF for hemodialysis access using an endovascular approach. In the procedure, two flexible magnetic catheters are inserted into an artery and vein in the arm. A small amount of radiofrequency energy is used to connect the artery and vein to create the fistula. The catheters are then removed and a brachial vein is coil-embolized, enabling future dialysis.

The everlinQ endoAVF System received European CE Mark in 2014 and Health Canada Medical Device License in 2016 for end-stage renal disease (ESRD) patients. It is not available for sale in the United States and is currently under review by the U.S. Food and Drug Administration.

About TVA Medical
TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage renal disease and other potential applications, such as peripheral vascular disease. More information is available at www.TVAMedical.com.

¹ United States Renal Data System. 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017.

SOURCE TVA Medical, Inc.

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