The majority of medical experts on a Food & Drug Administration (FDA) advisory panel voted on Friday to recommend that the agency reconsider its approval of the Wingspan Brain Stent. According to a Reuters report, most on the panel agreed that the benefits of the Wingspan Stent did not outweigh its risks, and that device has the potential to cause more harm in patients than traditional anti-clotting drug therapies.
The controversial Wingspan Brain Stent, approved for patients who have had one stroke and are at risk for additional strokes, has been marketed since 2005. The device was originally developed by Boston Scientific, but acquired by Stryker last year. Its 2005 approval was based on a single, uncontrolled study just 45 patients and was not designed to demonstrate whether the Wingspan Stent was more effective or even safer than medical therapy alone.
The FDA allowed Boston Scientific to apply for the Wingspan‘s approval under its Humanitarian Device Exemption program, which allows for clearance without proof that a device is safe or effective. Such approvals are allowed if a device addresses rare disease or condition and the manufacture can show development costs could exceed its financial returns for diseases affecting small patient populations. According to Reuters, the Wingspan Stent is the only system currently approved by the FDA for certain high-risk stroke patient.
Concerns about the safety of the Wingspan Brain Stent mounted last year, after a study published in the New England Journal of Medicine found patients who had received the device were found to have a 2.5-fold increase in stroke or death compared to those treated with blood-thinning medications. The study was halted early because of those findings, and prompted the group, Public Citizen, to call for a recall of the Wingspan Brain Stent.
Following the release of the study, the FDA decided to convene the 16-member panel that met Friday. The agency asked the group to determine if the benefits of the Wingspan Stent outweigh its risks. According to Reuters, most of the advisors recommended that the FDA reconsider its approval of the device. Most also agreed that Stryker should continue conducting tests of the Wingspan to determine which patients it would most likely benefit.
“I’m sensitive to the humanitarian use, and would like to see all alternatives on the table come last resort,” said Scott Evans, a researcher and teacher at Harvard University.
“But I did not see any data presentation that would leave me to believe the benefits (of Wingspan) would outweigh the potential harms.”
However, according to a Wall Street Journal report, some of the advisors did feel the Wingspan should remain available for especially hard-to-treat patients.
The FDA is not legally required to follow the recommendations of its advisory panels, but usually does so. Options available to the agency including revoking approval of the Wingspan Stent entirely, narrowing its approval to a more limited set of circumstances or requiring Stryker to provide more data to justify its continued availability, the Journal said.