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- W2052850489 abstract "The Food and Drug Administration (FDA) has been monitoring the use of drug-eluting stents (DES) since they were approved for use in the United States. The Cypher sirolimus-eluting stent (SES) was approved in 2003 and the Taxus Express 2 paclitaxel-eluting stent (PES) in 2004. Recent presentations at scientific meetings have suggested a small but significant increase in the rates of (1) death or myocardial infarction (MI) (possibly due to stent thrombosis) and (2) noncardiac mortality in DES-treated patients compared to patients treated with bare metal stents (BMS). The FDA therefore convened a public meeting of the Circulatory System Devices Advisory Panel on December 7 and 8, 2006, in an effort to fully characterize the risks, timing, and incidence of DES thrombosis. Cordis Corporation, Boston Scientific, and other US device companies presented on the incidence of stent thrombosis and overall safety of DES. The FDA asked the panel to address specific questions. 1. When used in accordance with their labeled indications, are DES associated with an increased rate of stent thrombosis, death, or myocardial infarction compared to bare metal stents? Most centers report DES utilization rates of N80%, with at least 60% of that being off-label. By definition, bofflabelQ use refers to practices for which a device or drug is not recommended by regulators, yet the FDA had asked the panel to make recommendations about such use." @default.
- W2052850489 created "2016-06-24" @default.
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- W2052850489 date "2007-01-01" @default.
- W2052850489 modified "2023-10-16" @default.
- W2052850489 title "Summary of the Food and Drug Administration's Circulatory System Devices Advisory Panel Meeting" @default.
- W2052850489 doi "https://doi.org/10.1016/j.carrev.2007.01.001" @default.
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