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Drug-coated stent safe, firm tells panel

GAITHERSBURG, Md., Dec. 7 (UPI) -- Taxus drug-eluting stents are as safe as bare-metal stents and better at stopping restenosis, Boston Scientific told an expert panel Thursday.

As a two-day meeting of a medical-devices advisory panel to the Food and Drug Administration got under way early Thursday, officials from the maker of the Taxus stent presented data from long-term clinical trials that they said show the Taxus paclitaxel-coated stent is as safe as bare-metal stents and "far more effective" in keeping arteries open and reducing the need for repeat procedures to address the re-closing of an artery caused by tissue growing through the stent, a condition called "in-stent restenosis."

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The data -- presented by Donald Baim, chief medical and scientific officer at Boston Scientific -- were based on an analysis of 2,797 patients who received Taxus or bare-metal stents and were followed for four years.

Baim told the panel the data showed Taxus reduced the incidence of restenosis by nearly 50 percent versus bare-metal stents.

Market analysts predicted this week that the panel would take a moderate stance in response to the new data on clotting risk and would likely suggest stronger guidelines on post-op anti-platelet therapy for stent patients to help prevent blood clots.

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Boston Scientific and Johnson & Johnson -- which makes the Cypher drug-eluting stent -- are currently the only two players with drug-eluting stents on the U.S. market, but the studies identifying the higher clotting risk had focused on Taxus.

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