FDA greenlights Covidien's stroke revascularization device

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The FDA has cleared Covidien's Solitaire FR revascularization device, which is intended to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels.

The Solitaire FR device 510(k) application was based on the results of the SWIFT (Solitaire With the Intention for Thrombectomy) clinical study, which was the first randomized clinical trial conducted on mechanical intervention for acute ischemic stroke. The study randomly assigned 113 stroke patients at 18 hospitals to a procedure to restore blood flow to the brain with either the Solitaire FR device or the Merci Retriever device within eight hours of stroke onset.

Dublin-based Covidien said that the Solitaire FR device received CE Mark approval in Europe and has been commercialized internationally since November 2009. The Solitaire FR device will be available in the U.S. in April.