March 26, 2008: FDA Makes Recommendations on Drug-Coated Stents
The U.S. Food and Drug Administration (FDA) has announced the development of guidelines to aid companies in the testing and manufacture of drug-coated stents, devices that are used to treat blocked heart arteries. The guidelines (called an "FDA guidance document") outline the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address safety concerns over drug-coated stents -- including risk of clot formation in some patients. (Read the FDA Press Release and Guidance for Industry)
September 14, 2006:FDA Updates Statement on Drug-Coated Stents
The FDA announced that it has been closely monitoringdrug-coated stents since they entered the U.S. market in2003 and 2004, and will continue to do so. New data suggests that there is a small but significant risk of stent thrombosis (blood clotting in the stent). However, the FDA does not yet have enoughinformation to draw any conclusions regarding the risk and causes of stent thrombosis. Click here toread the FDA's statement on coronary drug-coated (also called "drug-eluting") stents.
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