Boston Scientific’s Taxus Liberté approved
This article was originally published in The Gray Sheet
Executive Summary
Next-generation paclitaxel-eluting coronary stent will launch in the U.S. early next month following FDA approval, the firm announces Oct. 10. The approval was delayed by the firm's 2006 company-wide warning letter, and agency sign-off provides further evidence that the firm has largely resolved related quality issues. Boston Scientific's Taxus Express2 Atom paclitaxel-eluting stent was approved in September (1"The Gray Sheet" Sept. 29, 2008, p. 16). Liberté is indicated for de novo lesions < 28 mm in length in native coronary arteries with diameters of > 2.5 mm to < 4.00 mm. Deemed "approvable" by the agency in March, Liberté is intended to replace Taxus Express and is touted as more "deliverable" by Boston Scientific