The Food and Drug Administration has laid out new guidelines for the testing of drug-coated stents. This comes more than two years after safety concerns curtailed use of the devices. The proposed guidelines posted to the FDA’s Web site recommend device makers conduct large, analytic studies of their stents both before and after they are submitted to the agency. 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 attacks and other potentially fatal events.
As most of our readers know by now, stents are tiny, mesh-wire tubes that prop open arteries after they have been surgically cleared of fatty plaque. The introduction of drug coatings to the devices quickly made stents a highly lucrative business. This was to prevent scar tissue from growing over the mesh-wire. But, data has suggested that the drug coatings may put patients at higher risk of blood clots. As a result, sales fell to about $2 billion from a peak of $3.1 billion in 2005. A series of studies in 2006 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.
Medical societies urge patients to continue taking the drugs for at least a year after implantation. It should be noted that while FDA guidelines are not legally binding, companies typically follow them to ensure approval of their devices. The regulatory agency will take comments on the proposed guidelines for four months before redrafting them and issuing final guidelines. The FDA has cleared three drug-coated stents: Boston Scientific Corp.’s Taxus; Medtronic Inc.’s Endeavor; and Johnson & Johnson’s Cypher. Currently, about 650,000 patients in the U.S. have drug-coated stents. We will continue to follow this matter. Our firm is representing a number of clients who have had a bad experience with the stents.
Source: Associated Press
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