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

wait times, and reducing complications and costs." 

"Overall, we are very pleased with the outcomes demonstrated in this clinical study," said Adrian Ebner, MD, principal investigator of the FLEX-1 study and Chief of Cardiovascular Services at the Italian Hospital, Asuncion, Paraguay.  "Many of these patients were dependent on central venous catheters, and now have a functioning permanent vascular access delivered using a minimally-invasive procedure.  I believe many patients worldwide will benefit from this procedure."

The FLEX-1 Pilot Study is a non-randomized, prospective study on the feasibility of using the FLEX System to create AV fistulas in patients with kidney failure requiring hemodialysis without open surgery.  Sixteen patients were enrolled in the initial cohort and followed for 3 months.  Additional follow-up is ongoing.

"Two million people worldwide rely on hemodialysis three times a week to sustain life, and many are subjected to multiple procedures and long duration on infection-prone catheters while they wait for a permanent workable AV fistula.  There is an unmet need for a reliable, reproducible method to connect patients to the dialysis machine in a timely manner," said Adam L. Berman, CEO of TVA Medical. "We believe our technology has the potential to benefit hemodialysis patients around the world."

About the FLEX Catheter System
The TVA Medical FLEX system uses two vascular catheters, incorporating magnets and an RF electrode, that are delivered percutaneously to an artery and vein in the arm. When the catheters are magnetically aligned and positioned under fluoroscopy, RF energy is delivered to create an arteriovenous fistula without open surgery.  No implant is left behind.

About End Stage Renal Disease and Hemodialysis
Over 2 million ESRD patients worldwide receive hemodialys
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SOURCE TVA Medical, Inc.
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