Physicians request Solitaire™ FR device for randomized, open-label multi-center study
MANSFIELD, Mass. - Monday, January 30th 2012 [ME NewsWire]
(BUSINESS WIRE)-- Covidien (NYSE:COV), a leading global provider of
healthcare products, today announced that the Solitaire™ FR
Revascularization Device has been approved for investigational use in
the Interventional Management of Stroke (IMS III) trial. The Solitaire
FR device was approved by the IMS III Executive Committee in the
thrombectomy arm of the trial and was included in a recently approved
amendment submitted to the U.S. Food and Drug Administration (FDA).
The IMS III Trialwill compare a combined intravenous (IV) and
intra-arterial (IA) treatment approach to restoring blood flow to the
brain to the current standard FDA-approved treatment approach of giving
IV rTPA alone. A projected 900 subjects with moderate to severe ischemic
stroke will be enrolled at over 50 centers in the United States,
Canada, Australia and potentially Europe.The Executive Committee
approved the Solitaire FR device to ensure that the study and patients
have the most advanced treatment technologies to help determine the role
of endovascular therapy in acute ischemic stroke.
“We are excited to include the Solitaire FR Revascularization Device in
the National Institute of Neurological Disorders and Stroke-funded IMS
III trial. The addition of the device will help to expedite the
completion of this critical trial,” said Dr. Joseph Broderick, IMS III
Principal Investigator, Professor and Chair of the Department of
Neurology, University of Cincinnati.
Outside the United States, the Solitaire FR device has become the
leading technology for the endovascular treatment of acute ischemic
stroke, providing stroke physicians with an innovative treatment
technology over the existing options. The high success rate, fast
procedure time and ease of use experienced by physicians in Europe and
other regions who have used the device led physicians to request that it
be included in the IMS III Trial.
“The Solitaire FR is the first stent-based mechanical thrombectomy
device allowed into the study by IMS III investigators,” said Mark A.
Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We look
forward to the important results that will follow from this study
around the optimal treatment of acute ischemic stroke.”
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000
employees worldwide in more than 65 countries, and its products are sold
in over 140 countries. Please visit www.covidien.comto learn more about
our business.
Contacts
Vascular Therapies
Rachel Bloom-Baglin, 508-261-6651
Vice President, Communications
rachel.bloombaglin@covidien.com
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com
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