April 29, 2019

FDA issues Safety Communication for Stryker Wingspan Stent System

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on April 25 issued a Safety Communication on use of the Stryker Wingspan Stent System outside of approved indications.

The Wingspan Stent System is used to open narrowed arteries in the brains of patients with intracranial stenosis who are experiencing repeated strokes.


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A recent postmarket surveillance study (ie, WEAVE study) found a higher incidence of stroke or death within 72 hours of stent placement when the Wingspan was used in patients outside the FDA-approved indications for use.

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