Canada OKs Covidien's stroke revascularization device

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Health Canada has approved Covidien's Solitaire FR revascularization device, which is used to restore blood flow to the brain in patients suffering from acute ischemic stroke.

According to the Canadian Stroke Network’s BURST (Burden of Ischemic Stroke) study, the healthcare costs for patients in the first six months after they have a stroke is more than $2.5 billion a year in Canada. This is a newer generation device, and it demonstrated positive outcomes over previous generation devices in two studies presented at this year's European Society of Cardiology (ESC), the SWIFT trial and the TREVO 2 trial.

The Solitaire FR device received CE Mark approval in Europe and has been sold in that region by Covidien since November 2009. Solitaire FR is also available in the U.S., where it received FDA clearance in March.