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Boston Scientific’s next stent

This article was originally published in The Gray Sheet

Executive Summary

FDA approves investigational device exemption for ATLAS clinical trial of the Taxus Liberté next-generation paclitaxel-eluting stent system. The prospective, single-arm study will enroll 822 patients at 60 sites in the U.S., Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan. A slow-release formulation of Liberté will be evaluated to show non-inferiority compared with a historical control (combined TAXUS IV and V studies), with an endpoint of nine-month target vessel revascularization...
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