No Consensus Yet on Stent Panel

After one day of hearings and deliberations, CDRH's Circulatory System Devices Panel appears no closer to coming to a consensus about whether the clotting risks of drug-eluting stents outweigh their benefits, reports the New York Times. The panel appears to believe that the risks did not outweigh the benefits for those who were involved in clinical trials for Johnson & Johnson's Cypher and Boston Scientific's Taxus.

December 8, 2006

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No Consensus Yet on Stent Panel

Encouragingly, the panel said that in those cases, the devices were safe when used as directed. But those patients are generally healthier and more likely to follow instructions on taking anti-clotting medication than the general patient population. As a result, the panel is not yet ready to determine whether the risks outweigh the benefits in "real world" applications. It will consider a whole bunch of "real world" data today.

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