Stryker Corporation Stent May Not be Worth the Risks of Stroke, FDA Staff Report Says
Published: Mar 21, 2012
Stryker Corp. (SYK)’s Wingspan stent may not be worth the risks because the device has no added benefit over drugs used to prevent stroke in patients with narrowed arteries in the brain, U.S. regulators said today. The brain stent may be inferior in some cases than standard therapy for stroke prevention, including blood thinners, Food and Drug Administration staff wrote in a report today. The agency is scheduled on March 23 to convene an advisory panel to review the safety and effectiveness of the stent from Kalamazoo, Michigan-based Stryker. The FDA asked the panel to discuss whether the benefits of the stent might outweigh the risks.