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news.The safety of drug coated stents will be debated this week by the Food and Drug Administration following a number of studies calling their long-term benefits to cardiac patients into question.
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The FDA is holding a two-day advisory committee session to examine the safety of stents, a medical device inserted into damaged arteries which are designed to prop open the artery after a blockage has been removed. Newer stents, costing about $2,200 each, have a drug coating over the metal framework, designed to prevent the scarring associated with bare metal stents.
However, some research has pointed to blood clotting problems with the newer stents, and the FDA will be taking these studies into consideration in its guidance. Coated stents are popular for patients who have undergone cardiac surgery – some 2 million to 3 million people in the US now carry one of these devices in an artery.
Two brands of drug-coated stents are sold in the US: Taxus, marketed by Boston Scientific; and Cypher made by Cordis Corp, a subsidiary of Johnson & Johnson. Shares of Johnson & Johnson, the world’s biggest maker of heart stents, fell five cents in New York Stock Exchange composite trading.