A study finding that patients treated with the Wingspan Brain Stent System are more likely to suffer a stroke or death has prompted Public Citizen to petition the U.S. Food & Drug Administration (FDA) to recall the device. The consumer group has been joined in its petition by a former official from the FDA.
According to Public Citizen’s Dr. Sidney Wolf, the Wingspan Stent System “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.” That’s because the system 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. The device was cleared for use in patients who have had one stroke and are at risk for additional strokes.
In September, the New England Journal of Medicine published results from a study funded by the National Institutes of Health that found a 2.5-fold increase in stroke or death with the Wingspan stent system compared to those treated with blood-thinning medications. The study began in November 2008, but ended early last April, due to safety concerns.
The message from the trial could not be clearer: The risks of this intervention substantially outweigh any potential benefit to patients,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.
Professor Larry Kessler joined Public Citizen in filing the petition with the FDA.
“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.