Stryker Wingspan Stent Risks May Outweigh Benefits: FDA

Federal health experts indicate that the Stryker Wingspan brain stent’s benefits may be outweighed by the potential health risks, warning that it does not appear to perform any better than drugs that do not include invasive surgery to prevent a stroke. 

The Stryker Wingspan report (pdf) was released ahead of Friday’s meeting of the FDA Neurological Devices Panel, which will advise the FDA on the safety of the medical device.

In the report, a review by the FDA’s Office of Surveillance and Biostatistics found that the risk of stroke or death with the Stryker Wingspan appeared to be twice as high when compared to patients given aggressive medical care.

The Stryker Wingspan is a small mesh tube implanted in narrowed arteries to the brain to prevent strokes in people who have already suffered one. The stent was approved as a humanitarian use device (HDE), which allowed Boston Scientific, the original designer, to get it approved with just one uncontrolled trial involving only 45 patients.

FDA experts pointed out that enrollment in a National Institutes of Health (NIH) study on the Wingspan was stopped prematurely when they discovered that 14.7% of patients who received the stent suffered a stroke within 30 days, compared to 5.8% of those given drug therapies for stroke prevention. The trial included 451 patients, but was originally intended to include nearly 800. An independent monitoring board determined that it was unethical to continue the study.

The FDA experts determined that all indications point to there being “no added benefit, and in some cases, significantly worse outcomes” associated with use of the Wingspan.

Many are already calling for a Stryker Wingspan recall to be issued. The consumer watchdog group, Public Citizen, filed a petition with the FDA last year, urging the agency to pull the stent from the market. The group called the FDA’s failure to do so reckless.

The FDA advisory panel will answer a series of questions regarding its opinion on the safety and effectiveness of the Stryker Wingspan for the FDA. While the panel’s recommendations on the device are not binding for the FDA, the decisions often factor heavily into any regulatory actions taken by the agency.