The Wingspan Brain Stent marketed by Stryker Corp. may be doing more harm than good, according to a report authored by U.S. Food & Drug Administration (FDA) staff.
The Wingspan system has been on the market since 2005 and is used to open blocked arteries in the brain when clot-dissolving drugs do not work. It is supposed to improve blood flow and prevent people who have already had a stroke from having another one.
But a study published in the New England Journal of Medicine in September and funded by the National Institutes of Health (NIH) showed the stent may actually do more harm than treating the problems with drugs and lifestyle changes.
A panel of outside advisers to the FDA are planning to meet and discuss whether Stryker should perform more studies on the stent, or whether there is enough evidence to support its benefit.
However, FDA staff said the NIH-funded study looked at a broader population than the stent’s original target market. When the FDA analyzed a narrower population, there was no difference between the stent and anti-clotting drugs.
The FDA originally approved the Wingspan stent under a Humanitarian Device Exemption (HDE), meaning the agency allows a medical device to be sold without requiring stringent evidence of effectiveness. To qualify, the device must address a rare disease or condition, and show “probable” benefit.
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.
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.