IDEV Technologies, Inc., an emerging leader in the development and marketing of minimally invasive stent technologies, announced today that the company received a 510(k) clearance from FDA for the first interwoven nitinol self-expanding stent available in the United States. The newly approved SureSave(TM) Stent will be renamed SUPERA(TM).
SUPERA(TM) represents an advance over traditional laser cut nitinol tube stents in offering more than 360% greater radial strength than the next strongest offering. The unprecedented increase in radial strength is due to the product's novel interwoven nitinol wire design. Unlike traditional laser cut nitinol tube stents, the interwoven nitinol wire design allows for enhanced product strength without compromising product flexibility. Only SUPERA(TM) has been tested and proven to withstand over 10,000,000 cycles of repeated bending and flexing to 120 degrees without fracture in an engineering bench fatigue study. The combined benefits of unsurpassed radial strength and unmatched flexibility are expected to deliver exceptional product durability for patients by reducing the incidence of stent kinking, crushing and fracturing.
Thomas M.Tully, Chairman and CEO commented, "U.S. 510(k) approval for the IDEV stent is the second critical step toward the global commercialization of this novel technology. The first step came earlier this year when IDEV Technologies Inc. received a CE Mark for both Vascular and Non-Vascular applications for this device. The remaining critical step for the organization lies in packaging this technology in a simple, easy to use, system for widespread utilization among physicians. In addition, IDEV will continue to mobilize toward a global launch of its stent in select high volume medical centers in the U.S. and Europe in early 2007."
About IDEV Technologies, Inc.
IDEV Technologies, Inc. ("IDEV") is an innovator and developer of next generation medical devices for use in the interventional radiology, 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.