Update: Stryker calls FDA's Wingspan restriction a win
Stryker considers the FDA's decision to limit usage of its Wingspan brain stent system a win since the device will remain on the U.S. market.
Medical devices maker Stryker (NYSE:SYK) isn't downtrodden in light of the FDA's decision to restrict use of the Wingspan brain stent system to a narrower group of patients - Stryker seems genuinely delighted.
The FDA yesterday announced its decision to limit use of the Wingspan system, which was approved in 2005 under a Humanitarian Device Exemption, to a more specific group of stroke patients who aren't well-managed with drugs alone.
"Stryker is pleased to announce that we received communication from FDA concluding their review of the Wingspan Stent System and Gateway PTA Balloon Catheter and having determined that the Wingspan Stent should remain available for those patients who have failed to respond to, or who are ineligible for, an aggressive and comprehensive program of medical management," spokeswoman Tamara Cutler told MassDevice.com in an emailed statement. "