FDA Report Questions Safety, Efficacy of Wingspan Brain Stent

The Wingspan Brain Stent marketed by Stryker Corp. may be doing more harm than good, so says a report authored by U.S. Food & Drug Administration (FDA) staff. According to the FDA report, the controversial Wingspan Stent was no better at preventing strokes than standard drug therapy, and may be inferior in some cases compared to standard treatment.

According to Bloomberg News, the report was prepared in advance of today’s FDA advisory panel meeting, which will address the safety concerns surrounding the Wingspan Stent. The FDA has asked the panel of outside experts to determine if benefits of the stent might outweigh the risks.

The Wingspan Brain Stent System was originally developed by Boston Scientific, but acquired by Stryker last year. The device consists of a small, mesh metal tube or stent that is placed in the affected brain blood vessel, promoting blood flow through the arteries to the brain. The stent system was approved for patients who have had one stroke and are at risk for additional strokes.

The stent was approved in 2005 under the FDA’s Humanitarian Device Exemption program, which allows for clearance without proof that a device is safe or effective. HDE approvals require that a device address a rare disease or condition and the manufacture must show development costs could exceed its financial returns for diseases affecting small patient populations. The single, uncontrolled trial the FDA reviewed for that approval involved just 45 patients and was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone.

Last spring, a study involving the Wingspan Stent was halted after patients treated with the device were found to have a 2.5-fold increase in stroke or death compared to those treated with blood-thinning medication. The study’s findings were published in the New England Journal of Medicine in September.

According to the FDA staff report, the agency further examined groups of patients within that study.

“It is notable that all of the subgroup results point in the same direction of no added benefit, and in some cases, significantly worse outcomes,” FDA staff wrote.

According to Reuters, at today’s advisory panel meeting, members will discuss whether Stryker should perform more studies on the stent, or whether there is enough evidence to support its benefit. The FDA will make a final decision later, taking into account the advisers’ recommendation. However, the agency is not legally obliged to follow those recommendations.

Last year Public Citizen petitioned the FDA to withdraw its approval for the Wingspan Brain Stent System, and called on Stryker to recall it immediately. A former FDA official, Professor Larry Kessler, joined Public Citizen in filing the petition with the agency.

“With the conclusion of the recent (clinical) trial showing that Wingspan has a much higher complication rate than modern medical management, it is imperative that the FDA take swift and decisive action,” said Kessler, former director of the FDA’s Center for Device Evaluation and Radiologic Health (CDRH) Office of Surveillance and Biometrics, former director of the CDRH Office of Science and Engineering Laboratories and currently a professor in the University of Washington’s School of Public Health.

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