The FDA’s neurological devices panel will review clinical data from trials of Stryker’s (NYSE:SYK) Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.
The panel plans to consider pre-market and post-market data about the device, including the Gateway PTA balloon catheter and stent delivery system, to address concerns that Wingspan may lead to heightened risk of stroke or death.