FDAnews Device Daily Bulletin

The FDA Wednesday said it is limiting use of Stryker’s Wingspan brain stent, but stopped short of removing the device from the market entirely — as consumer advocates had urged. Under approved new labeling, the device is indicated only for patients with recurrent stroke despite medical management who have not had any new stroke symptoms in the seven days prior to stent placement. That appears to match the patient group used in the original humanitarian device exemption study.
Devices & Diagnostics Letter