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
SOURCE
