Physicians request Solitaire™ FR device for randomized, open-label
MANSFIELD, Mass.--(BUSINESS WIRE)--Jan. 30, 2012--
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).
III Trial will 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.”
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.com
to learn more about our business.
Rachel Bloom-Baglin, 508-261-6651
Lannum, CFA, 508-452-4343