Published date : 10 August 2012
Article date : 09 August 2012
The FDA has limited use of Stryker's Wingspan brain stent system to a narrower group of patients after studies suggested the device may increase stroke and death rates.
The system's use is now restricted to those with recurrent stroke who, despite medical management, have not experienced new stroke symptoms within seven days before treatment with Wingspan.
The FDA notice included that, "While Wingspan is not beneficial for the broad population of stroke patients studied in SAMMPRIS there is evidence from the original HDE study to show there are probable benefits of using Wingspan to treat the specific population of patients outlined in the new indications for use."
As a result, Wingspan devices, approved in 2005, won't be recalled.