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...