Revascularization Device Receives FDA Clearance

COVIDIEN

Covidien, a leading global provider of healthcare products, announces the Solitaire™ FR revascularization device has been cleared by the U.S. Food and Drug Administration. The Solitaire FR device 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 Solitaire With the Intention for Thrombectomy (SWIFT) clinical study. In this clinical study comparing two devices, the Solitaire FR device demonstrated superior performance to the Concentric Medical Merci Retriever™ device, a commercially available mechanical clot retriever. The SWIFT clinical study was the first randomized clinical trial ever 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. The Solitaire FR device showed a 2.5x benefit in restoring blood flow to the brain, as determined by a blinded core lab, a 1.7x improvement in post-stroke neurological function and a 55% reduction in mortality at 90 days. Learn more at http://bit.ly/yqeRrX.