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Medical Devices / Regulatory Affairs

FDA Issues Warning on Stryker’s Wingspan Stent System

April 29, 2019
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Use of the Stryker Wingspan stent system outside of approved indications leads to an increased risk of stroke or death, the FDA warned.

The system is used to open narrowed arteries in the brain of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. But it is only FDA-approved for patients between 22 and 80 years old and who meet specific criteria.

The agency issued the warning based on results from a multi-center study of 198 patients that found a higher incidence of stroke or death within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.

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