Covidien Solitaire FR Revascularization Device approved for investigational use

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).

“We look forward to the important results that will follow from this study around the optimal treatment of acute ischemic stroke.”

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."