FDA Limits Use Of Stryker's Wingspan Anti-Stroke Stent

Law360, New York (August 9, 2012, 2:31 PM EDT) -- The U.S. Food and Drug Administration on Wednesday significantly narrowed the group of patients allowed to use Stryker Corp.'s Wingspan brain artery-opening stent, after recent trials showed an increased risk of stroke and death in users compared to the use of medication alone, the regulator said.

According to the FDA's safety communication, Wingspan is one of only a few treatment options for intracranial stenosis, or narrowed arteries in the brain, which put patients at serious risk of stroke. However, several studies have shown that the stent...
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