, Nov. 10, 2011
/PRNewswire/ -- IDEV Technologies, Incorporated (IDEV), today announced the FDA has granted 510(k) clearance for the company's 6 French (6Fr) SUPERA VERITAS Transhepatic Biliary Stent System. The new lower profile system, approved for sale outside the U.S. earlier this year, is the latest enhancement to the delivery catheter utilized with the unique SUPERA stent, currently cleared in the U.S. for palliative treatment of biliary strictures produced by malignant neoplasms.
In addition to having a lower entry profile, the new 6Fr system is available in two catheter lengths, 80 cm and 120 cm, and offers even better efficiency and trackability.
"Feedback from our European customers confirms the new 6Fr system allows for improved ease of use, trackability and control of stent deployment," commented Christopher M. Owens, President and CEO of IDEV. "As the global market continues to move toward smaller delivery sizes, we believe these regulatory clearances will provide an opportunity to accelerate market expansion and adoption of our technology. We are pleased to now have this product available to our U.S. customers and patients."
Full commercial launch of the 6Fr SUPERA VERITAS Transhepatic Biliary Stent System is anticipated in January 2012.
About IDEV Technologies, Incorporated
IDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in interventional radiology, vascular surgery and cardiology. IDEV's worldwide headquarters is located in Webster, Texas and its European headquarters is located in Beuningen, The Netherlands.
The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe, Canada, Australia and Hong Kong for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).
For more information please visit www.idevmd.com.
Vice President Global Marketing
IDEV Technologies, Incorporated
SOURCE IDEV Technologies, Incorporated