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FDA Narrows Indication For Stryker’s Wingspan Intracranial Stent

Agency restricts use of the device to a select patient population with severe intracranial stenosis and recurrent stroke after reviewing studies indicating the device could actually lead to increased rates of stroke and death.

Stryker’s Wingspan intracranial stent got its wings clipped slightly with FDA’s Aug. 8 approval of a narrowed indication to address concerns raised by recent studies suggesting the device could lead to increased rates of stroke and death.

The agency issued a safety communication

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