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FDA warns doctors about ignoring stent usage guidelines

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Posted at 2:23 PM, Apr 25, 2019

The Stryker Wingspan Stent System used to open narrowed arteries in patients who have repeated strokes is not always used in following FDA guidelines, and the agency has issued a warning about that.

A brief says the FDA assesses benefits and risks of devices, and in the case of Wingspan, it is approved only for use in a specific subset of patients with a life-threatening neurological condition.

"While the device can play an important role in opening narrowed arteries in the brain of certain patients diagnosed with intracranial stenosis who are experiencing repeated strokes, new study data issued today reinforces that the risk of stroke or death is higher when this device is used in patient populations outside of the FDA-approved indications for use,” said William Maisel, M.D., M.P.H., chief medical officer in the FDA’s Center for Devices and Radiological Health, in an FDA brief posted online.

“As a follow up to previous alerts about this device, today the FDA is reminding health care professionals and patients to carefully follow the Wingspan device labeling, instructions for use and to consider the specific patient selection criteria for this device so they can appropriately determine whether the device is right for them. This alert is part of our ongoing commitment to device safety and our work to protect patients when we become aware of safety concerns involving medical devices," the brief states.

The FDA's Wingspan Stent System Postmarket Surveillance study data shows a higher incidence of stroke or death when Wingspan is used outside of the FDA-approved indications for use.