WEBSTER, Texas, April 14, 2011 /PRNewswire/ -- The Medical Devices Bureau of Health Canada has granted regulatory approval for the SUPERA VERITAS stent system for use in biliary and peripheral procedures. IDEV's unique stent was previously available on a limited basis only, through the Special Access Program.
Christopher Owens, President and CEO of IDEV, commented, "With the full regulatory approval that has been granted we can immediately launch SUPERA VERITAS throughout Canada. Based on early work with key physicians we anticipate rapid acceptance of our technology, and are pleased to offer this treatment option to physicians and their patients."
The approval clears the way for clinicians to utilize the SUPERA stent for patients with peripheral vascular disease (PVD) as well as those diagnosed with biliary strictures resulting from malignant neoplasms. The proven mechanical characteristics of the SUPERA stent, including unmatched radial strength and fracture resistance, may result in improved clinical outcomes for these patients.
"Gaining full approval in Canada for SUPERA VERITAS is a significant development for the market," stated Vincent Oliva, M.D., Chief of Interventional Radiology at Centre Hospitalier de L'Universite de Montreal (CHUM). "Based upon my experience, the highly differentiated features of the device, including its high radial strength and fracture resistance, and the clinical data presented showing exceptional outcomes, provide clinicians with a new and exciting option for treating PVD."
About IDEV Technologies, IncorporatedIDEV 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. For more information please visit www.idevmd.com.
The SUPERA stent is currently indicated in the U.S. for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe and Australia for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).Contact:
Donna LucchesiVice President Global MarketingIDEV Technologies, Incorporated(281) 525-2000
|SOURCE IDEV Technologies, Incorporated|
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