FDA to seek more safety data on stents
AP/Yahoo News, March 27, 2008
More than two years after safety concerns curtailed use of the devices, the Food and Drug Administration has laid out new guidelines for the testing of drug-coated stents. The FDA said companies should be prepared to track patients for up to five years after their stents are approved to monitor blood clots, heart attack and other potentially fatal events. Previous studies showed that months after they are implanted, stent coatings can increase the risk of life-threatening blood clots unless patients continue to take anti-clotting drugs.