WIRE)–Covidien, 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
The IMS 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.
Posted by Sean Fenske, Editor-in-Chief, MDT