Covidien Revascularization Device Approved for Interventional Management of Stroke Trial

COVIDIEN

Covidien, a leading global provider of healthcare products, announces 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 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. Learn more at http://bit.ly/A2e76x