The group Public Citizen is calling for the recall of Stryker Corp.’s Wingspan Brain Stent System, asserting that the device increases the risk a patient will suffer a stroke, the very condition it is supposed to prevent. The group has petitioned the U.S. Food & Drug Administration (FDA) to withdraw its approval for the Wingspan Brain Stent System, and wants Stryker to recall it immediately.
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 affective 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 Wingspan Stent 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. 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. 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.”
According to a statement issued by Public Citizen, it is calling for the Wingspan Brain Stent recall after a new study found its use may place patients at a higher risk of stroke or death. The study, which was published online Sept. 7 in the New England Journal of Medicine, began in November 2008, but ended early last April, due to safety concerns. The study found a 2.5-fold increase in stroke or death with the Wingspan stent system compared to those treated with blood-thinning medications.
Public Citizen asserts in a letter to the FDA that the National Institutes of Health-funded study “conclusively demonstrated that treatment of high-risk patients with intracranial artery stenosis with the Wingspan Stent System plus aggressive medical therapy provides substantially less benefit and causes significantly more harm in comparison to aggressive medical treatment alone.”
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.