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Final Modules Of Boston Scientific’s Second-Generation Small Vessel And Long Lesion Stents Submitted To FDA

Boston Scientific Corporation submitted the final modules to FDA for both its TAXUS Liberte Atom Paclitaxel-Eluting Coronary Stent System and its TAXUS Liberte Long Paclitaxel-Eluting Coronary Stent System. Once approved, the TAXUS Liberte Atom Stent will become the company's second 2.25 mm diameter drug-eluting stent (DES) available in the US. The TAXUS Liberte Long Stent is designed to be the first 38 mm drug-eluting stent available in the US. The data from 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 is included in the PMA submissions. 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. TAXUS ATLAS SV and LL one-year results from the studies met their primary endpoint of non-inferior, nine-month, and in-segment diameter stenosis versus the TAXUS Express Stent control group. The studies reported a significant reduction in small vessel in-stent restenosis and major adverse coronary events (MACE) in patients treated with the TAXUS Liberte Atom Stent, and a significantly reduced rate of myocardial infarction (heart attack) in patients with long lesions treated with the TAXUS Liberte Long Stent. Patients with small vessels treated with the TAXUS Liberte Atom Stent reported significantly lower nine-month angiographic in-segment late loss (0.16 mm vs. 0.32 mm, p=0.0146), reduced nine-month angiographic restenosis (18.5% vs. 32.7%, p=0.0219), reduced 12-month TLR (6.1% vs. 16.9%, p=0.0039), and reduced rates of stent thrombosis (0.4% vs. 1.5%, p=0.39). Patients with long lesions treated with the TAXUS Liberte Long Stent reported a significantly reduced 12-month rate of myocardial infarction (1.4% vs. 6.5%, p= 0.0246) as well as a trend toward fewer stent thromboses (0% vs. 0.7%, p=0.48).