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FDA Limits Use of Stryker Wingspan Brain Stent

August 9, 2012 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication and Press Release to announcing a change to the approved indications for the Stryker Wingspan brain stent system. The new indications strictly limit the approval to patients who are suffering multiple strokes due to severe intracranial stenosis (narrowing of the blood vessels in the brain).

The FDA is warning that the Wingspan brain stent should not be used to treat transient ischemic attacks (TIAs) or treating a stroke within a week of symptom onset.

The panel members and a later FDA review found that the Wingspan should remain an option for treating patients who have recurrent strokes despite treatment who have not had new stroke symptoms within the last week. According to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, “The FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options.”

The Stryker’s Wingspan Brain Stent System is a device that is used to open narrowed arteries caused by intracranial stenosis (a life-threatening condition where plaque narrows brain arteries). People with this condition have reduced blood-flow to sections of their brain and they are at high risk of stroke. The Wingspan brain stent is used to prop open these narrowed arteries. Its design is similar to stents used in the heart, but much smaller.

The Wingspan brain stent was approved in 2005 under the Humanitarian Device Exemption (HDE). Devices approved under this process do not need to submit the results of a scientifically valid clinical investigation demonstrating that the device is effective for its intended purpose. The application does require that the device does not present an unnecessary risk.

A study published in April 2011, more than six years after the Wingspan brain stent was approved, had to be halted after researchers found that patients treated with the brain stent were 2.5-times more likely to have a stroke or die within 30 days of surgery.

More than one year after this study was published, the FDA completed its review and found that “Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan.”

The labels on the device will be updated to include the new indications, contraindications, warnings, and precautions with the risk information.

The FDA has also asked Stryker to conduct a post-marketing surveillance study to better understand the safety and effectiveness of the Wingspan brain stent.

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