Data Analysis Unfavorable for Drug-Eluting Stents

The researchers conclude that there is "a small but real hazard of late stent thrombosis with drug-eluting stents." The findings, published in the December issue of the American Journal of Medicine, are sure to make next week's meeting of CDRH's Circulatory System Devices Panel even more interesting. The meeting, scheduled for Dec. 7-8, could produce some consensus among FDA and doctors about the safety issues related to drug-eluting stents. It could go a long way toward determining future levels of use in the United States. Industry has a lot at stake here.