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Consumer Group Wants Brain Stent Recalled

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Advocacy group, Public Citizen, wants the Stryker Wingspan Brain Stent recalled following a recent study that linked the stent system to a significant increase in stroke or death. Ironically, the Wingspan stent system is meant to prevent stroke by clearing blood flow to the brain.

A former official with the U.S. Food and Drug Administration (FDA) has joined Public Citizen and other advocacy groups in seeking the federal government’s withdrawal of the Stryker device, said Bloomberg Businessweek. According to Public Citizen, a recent National Institutes of Health- (NIH) funded study revealed that the Stryker Wingspan stent system was linked to a 2.5-fold increased risk for stroke or death, wrote Businessweek. The advocates filed their petition—co-signed by a former executive from the FDA’s device division—this Wednesday.

“I can see no reason why this device should continue to be available,” said Professor Larry Kessler, in a letter that accompanied the petition. Kessler worked at the FDA’s device division for more that 12 years and is, today, a professor of health science at the University of Washington, according to Businessweek.

Businessweek explained that the Wingspan, approved in 2005, received a quick approval meant for devices that treat rare diseases and conditions; Stryker acquired the Wingspan from Boston Scientific, its original manufacturer. The program, the FDA’s Humanitarian Device Exemption Program, enables devices to receive approval based on preliminary evidence as long a “reasonable basis” exists that finds the device’s benefits outweigh its risks.

Dr. Sidney Wolfe of Public Citizen said that by using this program, Boston Scientific, “was able to gain marketing approval based on a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone,” Businessweek reported. The Wingspan stent, approved for stroke patients at risk for a second or additional strokes, is a tiny, mesh, metal tube that is put in place in the brain’s narrowed arteries and inflated.

The study that prompted the Public Citizen petition was published in September’s New England Journal of Medicine, and revealed that patients treated with the stent were likelier to suffer a second stroke or die within one month, versus patients who received a combination of blood thinners. That study involved 158 stroke patients treated with Wingspan, whose progress was followed for six months; the group was compared to another group who only received drug therapy. The study was halted April in Adue to safety concerns.

“We hypothesized that stenting would be more effective than medical therapy and found exactly the opposite,” said Dr. Marc I. Chimowitz, lead researcher and professor of neurology at the Medical University of South Carolina, wrote USA Today, previously, concerning a brain stent study. “In this population, given the results of the study, I would recommend aggressive medical management,” he added.

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