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NATICK, Mass. and GAITHERSBURG, Md., Dec. 7 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today presented data on its long- term randomized clinical trials to a special U.S. Food and Drug Administration (FDA) panel, showing that the TAXUS(R) paclitaxel-eluting coronary stent is as safe as bare-metal stents and far more effective in keeping arteries open and reducing the need for repeat procedures.
The data were presented by Dr. Donald S. Baim, Chief Medical and Scientific Officer for Boston Scientific, during the first day of a two-day hearing before a panel of experts assembled by the FDA in response to concerns about the incidence of late stent thrombosis, or blood clots, in drug-eluting stents.
The Boston Scientific data presented by Dr. Baim were based on a detailed analysis of 2,797 patients who received TAXUS or bare-metal stents for approved indications and were followed closely for four years. The data showed that the TAXUS stent reduced the need to for repeat procedures due to restenosis by nearly 50 percent compared to bare-metal stents. Restenosis is a condition in…
Source: HighBeam Research, Data Presented To FDA Panel Show TAXUS Drug-Eluting Stents as Safe as...