Healthcare Industry News:  biliary strictures 

Devices Interventional FDA

 News Release - January 31, 2008

IDEV Technologies Inc. Receives 510(k) Clearance for New SUPERA(TM) Biliary Stent Delivery Catheter

HOUSTON--(HSMN NewsFeed)--IDEV Technologies, Inc.(”IDEV”), an emerging leader in the development and marketing of minimally invasive stent technologies, today announces receipt of 510(k) clearance for a new SUPERA™ Biliary Stent Delivery Catheter. The improved SUPERA™ Transhepatic Biliary System is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. The new SUPERA™ Biliary Stent Delivery Catheter is the first to offer a retrieval capability of up to 95% for a partially deployed SUPERA Biliary Stent.

The SUPERA™ Biliary Stent Delivery Catheter also provides the operator with enhanced control during a procedure. A unique reciprocating ratchet mechanism allows the operator to precisely place the stent in the biliary tract.

The new SUPERA™ Biliary Stent Delivery Catheter was developed specifically to address the unique design of the SUPERA™ Self-expanding Biliary Stent. The SUPERA™ Self-expanding Biliary Stent offers more than 360% greater radial force than other commercially available laser cut nitinol tube (“LCNT”) self-expanding biliary stents. The unprecedented increase in radial force is due to the novel Wire Interwoven Nitinol (“W.I.N.”) design of the stent. Unlike traditional LCNT self-expanding biliary stents, the W.I.N. design allows for enhanced product radial force and flexibility.

Thomas M. Tully, Chairman and CEO commented, “U.S. 510(k) approval for the SUPERA™ Biliary Stent Delivery Catheter is the third and final regulatory step toward the global commercialization of this novel technology. The first and second steps came earlier when IDEV Technologies Inc. received 510(k) approval for the stent and an earlier generation SUPERA™ Biliary Stent Delivery Catheter system along with CE Mark approval for the SUPERA™ Peripheral Vascular System in Europe. IDEV will begin working toward a domestic launch of the SUPERA™ Transhepatic Biliary System in select medical centers in the U.S. The first biliary cases will be scheduled at MD Anderson Medical Center by the end of this week.”

About IDEV Technologies, Inc.

IDEV Technologies, Inc. is an innovator and developer of next generation medical devices for use in the interventional radiology, gastroenterology, vascular surgery and cardiology device marketplace. IDEV is based in Houston, Texas and its current portfolio contains over thirty technologies exclusively licensed from the M.D. Anderson Cancer Center, representing over a $5.0 billion dollar market opportunity worldwide.

Source: IDEV Technologies

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