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FDAnews Device Daily Bulletin
Oct. 5, 2012 | Vol. 9 No. 196
SAMMPRIS Data Review Fails to Find ‘Smoking Gun’ Behind Strokes
An analysis of data from a pivotal trial of Stryker’s Wingspan Stent that was aborted due to a high stroke rate failed to find a single “smoking gun” behind the adverse events and likely won’t lead to a reconsideration of the FDA’s recent use restrictions, one expert says. The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial was stopped within 30 days of initiation last fall due to a high rate of stroke and death.
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