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Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents
Date:2/5/2009

Journal of American College of Cardiology publishes positive ATLAS clinical data

NATICK, Mass., Feb. 5 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final modules of the Company's Pre-Market Approval (PMA) applications for both its TAXUS(R) Liberte(R) Atom(TM) Paclitaxel-Eluting Coronary Stent System and its TAXUS Liberte Long(TM) Paclitaxel-Eluting Coronary Stent System. If approved, the TAXUS Liberte Atom Stent will become the Company's second 2.25 mm diameter drug-eluting stent (DES) available in the United States. It will then likely succeed the TAXUS Express(TM) Atom Stent, which is the Company's first approved small stent and the only DES currently approved by the FDA to treat small vessels. The TAXUS Liberte Long Stent is designed to be the first 38 mm drug-eluting stent available in the U.S. and will further expand the Company's leading DES portfolio.

These PMA submissions include clinical data from the global, multi-center TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) studies, designed to compare the performance of the TAXUS Liberte Atom and TAXUS Liberte Long Stents with Boston Scientific's first-generation TAXUS Express Stent. While the second-generation TAXUS Liberte Stent uses identical drug dose, polymer and release kinetics as the TAXUS Express Stent, it features thinner struts and a uniform architecture specifically designed for drug delivery.

One-year results from the TAXUS ATLAS SV and LL studies were published in the December 2008 issue of the Journal of American College of Cardiology. The studies both met their primary endpoint of non-inferior, nine-month, in-segment diameter stenosis versus the TAXUS Express Stent control group. They reported a significant reduction in small
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SOURCE Boston Scientific Corporation
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