FDA Limits Use of Stryker Wingspan Brain Stent

August 9, 2012 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication to warn that the Wingspan brain stent (a device used to prevent strokes by propping open arteries in the brain) should only be used on a select group of patients. The new indications and contraindications strictly limit the device’s approval for patients who have had multiple strokes due to severely narrowed arteries, after all other treatments fail, and the patient had not had a stroke in the last week.

Furthermore, the FDA is specifically warning that the Wingspan brain stent should not be used to treat patients who have transient ischemic attacks or those who have had a stroke within the last seven days.

The FDA made this decision after reviewing recent studies and conducting an expert panel meeting. Although studies have raised serious safety concerns, but according to Dr. Jeffrey Shuren, FDA director of the medical device department, “The FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options.”

A study published in April 2011 (more than six years after the Wingspan brain stent was approved by the FDA) found that the device was associated with a 2.5-fold increased risk of stroke or death within 30 days of surgery. The FDA reviewed studies and they agreed. The FDA now warns, “Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan.”

In addition to the safety announcement, the FDA is also requiring manufacturers to update the warning label, contraindications, risk information, and precautions for the device. Furthermore, Stryker will be required to conduct a post-marketing surveillance study to get a better picture of the device’s safety and effectiveness.

When the FDA approved the Wingspan brain stent in 2005, Stryker was not required to conduct safety tests. The device was approved under the Humanitarian Use Exemption — so long as a new device is intended to treat a condition that affects fewer than 4,000 people per year, manufacturers do not need to submit the results of scientifically valid study demonstrating that the device is effective. They only need to show that the device does not present an unnecessary safety risk.

Unfortunately, it appears that the device does present an unnecessary safety risk for some people who suffer from recurrent strokes. The study published in April 2011 had to be halted prematurely after researchers found the device associated with an alarming number of recurrent strokes and death.

Styker’s Wingspan Brain Stent is a medical device that is used to re-open arteries in the brain that have been narrowed due to build-up of plaque (intracranial stenosis). People who have this condition suffer decreased blood-flow to sections of their brain, and they have a high risk of recurrent strokes, which may be debilitating or fatal.

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