March 26, 2008: FDA Makes Recommendations on Drug-Coated Stents

US Food and Drug Administration made its announcement about the guidelines to help companies in the testing and manufacturing of drug-coated stents and equipment for treating clogged heart arteries. The guidelines, also known as FDA guidance document, summarizes the agency’s recommendations for pre-market clinical assessment and post-market studies, that can give data to address the safety concerns over the drug-coated stents, including risks of formation of blood clots in some of the patients.

September 14, 2006: FDA Updates Statement on Drug-Coated Stents

FDA declared that it was monitoring the drug-coated stents since they have entered the US market in 2003 and 2004, and will keep on doing it. There are new data that suggest that there is small but significant potential risk of stent thrombosis or the clotting of blood in the stent. But the FDA also admitted that they do not have sufficient information yet to give any conclusion about the risk and reasons of stent thrombosis.