IDEV Technologies, Inc. has received a 510(k) clearance from FDA for the first interwoven nitinol self-expanding stent available in the U.S for palliative treatment of malignant strictures in the biliary tree.
The newly approved SureSave Stent will be renamed SUPERA.
SUPERA represents an advance over traditional laser cut nitinol tube stents in offering more than 360 percent 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. The company expects the product to deliver better durability for patients by reducing the incidence of stent kinking, crushing and fracturing.
A U.S. Launch into U.S. medical centers and Europe is planned for early 2007.
For more information, contact Tony Anzalone, 281-333-1998.