DES Back Under FDA’s Microscope
The FDA will revisit a device tomorrow that it cleared for U.S. sale three years ago — drug-eluting stents will be the subject of a two-day, 18-hour meeting of FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee, Dec. 7 and 8 at the Hilton Washington DC North in Gaithersburg, MD.
The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents. Oral presentations from the public are slated throughout the committee’s deliberations on both days.
Presentations from Boston Scientific Corp. and Cordis are scheduled for the Thursday session at 10:30 a.m. and 4 p.m.