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FDA stays tuned to Taxus adverse events

This article was originally published in The Gray Sheet

Executive Summary

Agency pledges to keep the public apprised of complaints related to the Boston Scientific paclitaxel-eluting stent, but says collected data detailing 28 Taxus incidents to date are insufficient to justify a formal solicitation similar to last October's "web notification" about J&J/Cordis' Cypher thrombosis rates. Some physicians have reported that the Taxus delivery system resists extraction after stent deployment, possibly due to improper balloon deflation. The incident rate is about 11.8 complaints per 1,000 used, Boston Scientific says, attributing the problems to physicians unfamiliar with the system (1"The Gray Sheet" April 26, 2004, p. 5)...
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