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TVA Medical's Minimally Invasive System for Hemodialysis Access Demonstrates Success in Clinical Study
Date:9/26/2013

AUSTIN, Texas, Sept. 26, 2013 /PRNewswire/ -- Preliminary data presented last week at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual scientific meeting demonstrated that TVA Medical's FLEX System can create vascular access for hemodialysis patients without traditional open surgery.  The technology is being studied outside of the United States and is currently not available in the U.S.  The Company intends to seek Food and Drug Administration clearance in the future.    

(Logo: http://photos.prnewswire.com/prnh/20130610/DA29604LOGO)

The study demonstrated that TVA Medical's vascular catheter-based FLEX System can create autogenous arterio-venous fistulas (AV fistulas) for hemodialysis patients with 94% procedural success. 

Surgical AV fistulas are the current gold-standard for hemodialysis access, but they are plagued by high failure rates and frequent revisions resulting in enormous healthcare costs.  Patients receiving surgical AV fistulas require an average of 2-3 additional interventions to achieve a usable fistula1, which can delay availability of the AV fistula for hemodialysis by 5-12 months2.  Additionally, 30-60% of AV fistulas are never usable for dialysis, despite numerous re-interventions.1,3,4

"The preliminary results of this first in human study demonstrate that we can create usable autogenous AV fistulas without open surgery," said Dheeraj K. Rajan, MD, an investigator of the FLEX-1 study and Head of Vascular and Interventional Radiology at University of Toronto, Canada. "Moving to an entirely percutaneous procedure for vascular access has the potential to dramatically improve patient care by improving fistula usability, reducing surgical
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SOURCE TVA Medical, Inc.
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