Boston Scientific Gains Approval Of Taxus Atom Stent For Small Vessels
This article was originally published in The Gray Sheet
Executive Summary
FDA approval for two Boston Scientific Taxus Express2 stents signals the firm is finally coming out from under the company-wide warning letter that has prevented it from launching new products, and suggests the agency will soon approve its next-generation Liberté paclitaxel-eluting stent
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Boston Scientific’s Taxus Liberté approved
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
Boston Scientific’s Taxus Liberté approved
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
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