Stroke: Covidien wins Canadian OK for its Solitaire revascularization device

December 13, 2012 by MassDevice staff

Health Canada approves Covidien's to Solitaire revascularization device for restoring blood flow to the brain in patients with acute ischemic stroke.

Covidien logo

Medtech giant Covidien (NYSE:COV) won Health Canada approval for its Solitaire FR revascularization device, intended to remove blood clots and restore blood flow in the brains of patients suffering acute ischemic stroke.

"Stroke is a widespread public health issue, with approximately 50,000 Canadians experiencing a stroke annually," president of vascular therapies Stacy Enxing Seng said in prepared remarks. "Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated."

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The FDA cleared Solitaire in March on the basis of data gathered during Covidien's Swift study, the first of its kind to compare mechanical interventions for acute ischemic stroke. The company has had CE Mark approval for the device in the European Union since 2009.