IMS III Stroke Trial to Include Covidien's Solitaire FR Device

January 30, 2012—Covidien (Mansfield, MA) announced that the Solitaire FR revascularization device has been approved for investigational use in the Interventional Management of Stroke trial (IMS III).

The company noted that the IMS III trial will compare a combined intravenous and intra-arterial treatment to the standard FDA-approved approach of administering intravenous rt-PA (recombinant tissue plasminogen activator) alone for restoring blood flow to the brain. A projected 900 subjects with moderate to severe ischemic stroke will be enrolled at more than 50 centers in the United States, Canada, Australia, and potentially in Europe.

According to Covidien, the Solitaire FR device was approved by the IMS III Executive Committee in the thrombectomy arm of the trial and included in a recently approved amendment submitted to the US Food and Drug Administration. The company stated that the Solitaire FR device is the first stent-based mechanical thrombectomy device allowed into the study by IMS III investigators,  and that the Executive Committee approved its use to ensure that the study included 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,” commented Joseph Broderick, MD, who is the IMS III trial's Principal Investigator. “The addition of the device will help to expedite the completion of this critical trial.”