Clotting Data Prompts FDA To Promise Stent Review

Law360, New York (September 15, 2006, 12:00 AM EDT) -- The U.S. Food and Drug Administration is concerned about recent study results of the long-term effects of drug-coated stents and will soon look into data at both Boston Scientific Corp. and rival Johnson & Johnson, according to a statement from the agency.

The FDA’s Center for Devices and Radiological Health said on Sept. 14 that it plans to "more formally evaluate" certain studies after evidence of blood clotting emerged at recent conferences in Atlanta and Barcelona, Spain.

Boston Scientific recently reported a small but higher risk...
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