Stryker Wingspan Stent System: Safety Communication - Narrowed Indications for Use
MedSun: Newsletter #76, September 2012
FDA Medical Device Safety
The FDA is informing health care providers and patients that the indications for use and labeling for the Wingspan stent have changed to limit the use of Wingspan to a narrow, select group of patients and conditions. Generally, a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB).
FDA Medical Device Safety. Stryker Wingspan Stent System: Safety Communication - Narrowed Indications for Use. August 8, 2012.