FDA eschews recall, instead restricts use of Stryker's Wingspan brain stents
Stryker avoids a recall as the FDA opts to restrict use of the medical device company's Wingspan brain stent system to a narrower group of patients after studies suggested the device may increase stroke and death rates.
It's mixed news for Stryker (NYSE:SYK) today as the FDA limited use of the medical device company's Wingspan brain stent system to a narrower group of patients over concerns that the devices may do more harm than good.
The FDA revised the device's approval for patients with recurrent stroke that isn't well managed through drugs alone and who have not had any new stroke symptoms within a week prior to implantation of the Wingspan stent, according to the FDA notice.
That means the Wingspan devices, which were approved in 2005 under a Humanitarian Device Exemption, won't undergo a recall as called for by consumer watchdog groups and the former medical device director for the FDA.