AUSTIN, Texas, Feb. 5, 2016 /PRNewswire/ -- TVA Medical, Inc., a medical device company developing innovative therapies for end-stage renal disease (ESRD), today announced that its everlinQTM endoAVF System has received NUB (German Neue Untersuchungs und Behandlungsmethoden) Status 1 approval across more than 80 leading hospitals in Germany.
The approval was granted under the German Institute for the Hospital Remuneration System (InEK) NUB program for facilitating the introduction of new and innovative medical technologies. The designation of NUB Status 1 is the highest level available, and entitles the 80+ hospitals with NUB approval to negotiate with insurance companies for additional funding to cover the cost of the everlinQ™ endoAVF System.
"This favorable decision from InEK represents a major milestone in our reimbursement efforts," stated Adam L. Berman, President & Chief Executive Officer of TVA Medical. "We believe this decision validates the clinical value of the innovative everlinQ technology and, based on the high level of interest among physicians in Germany, will facilitate patient access to the everlinQ endoAVF System."
The everlinQ endoAVF System is designed to create an arteriovenous fistula for hemodialysis using an endovascular approach via catheter-delivered radiofrequency energy. The technology received CE mark in 2014, and recently the company announced positive primary endpoint data at the Leipzig Interventional Course (LINC) 2016 from a prospective, multicenter clinical study evaluating the everlinQ endoAVF System. TVA Medical will begin controlled commercialization efforts and a post-market study in Europe this year. The everlinQ endoAVF System is not currently available in the United States and has not been evaluated by the U.S. Food and Drug Administration.
Worldwide, 3 million people with end stage kidney failure receive hemodialysis therapy and require vascular access to connect their blood circulation to a dialysis machine.1 AV fistulas are the preferred approach to achieve vascular access but are associated with high failure rates, often as high as 60 percent.2,3
About the everlinQ endoAVF System
The everlinQ endoAVF System creates an AV fistula for hemodialysis access using an endovascular approach. In the procedure, two thin, 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, and the catheters are removed.
About TVA Medical
TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage renal disease and other potential applications. More information is available at www.TVAMedical.com
1 Liyanage et al. Lancet.10.1016/S0140-6736.
2 Al-jaishi, et al. Am J Kidney Dis 2014;63:464-78.
3 Lok. Clin J Am Soc Nephrol 2: 1043-1053, 2007.
SOURCE TVA Medical, Inc.