IDEV Announces Full Canadian Regulatory Approval for SUPERA VERITAS(R)By Idev Technologies Incorporated, PRNE
Wednesday, April 13, 2011
WEBSTER, Texas, April 14, 2011 - 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, 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.
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 Lucchesi Vice President Global Marketing IDEV Technologies, Incorporated +1-281-525-2000
Tags: April 14, canada, Idev Technologies Incorporated, texas, Webster