Boston Scientific Submits Final Modules to FDA for Second-Generation Small Vessel, Long Lesion Stents
February 6, 2009 - Boston Scientific Corp. yesterday submitted to the FDA the final modules of the company’s pre-market approval (PMA) applications for both its TAXUS Liberte Atom Paclitaxel-Eluting Coronary Stent System and its TAXUS Liberte Long Paclitaxel-Eluting Coronary Stent System.
If approved, the TAXUS Liberte Atom will become the company’s second 2.25 mm diameter drug-eluting stent (DES) available in the U.S. It will then likely succeed the TAXUS Express 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.
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. 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 in patients with long lesions treated with the TAXUS Liberte Long Stent.
“In the ATLAS study, lower target lesion revascularization (TLR) rates contributed to a significantly lower rate of MACE, including heart attacks, with the TAXUS Liberte Atom Stent," said Mark A. Turco, M.D., director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, and co-principal investigator of the ATLAS trial. “The thinner struts of the TAXUS Liberte Atom Stent are designed to improve its deliverability and conformability, which is important when treating small vessels. The TAXUS Liberte Stent also features an advanced stent cell geometry that has been designed to allow for more consistent drug distribution.”
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 percent), reduced 12-month TLR (6.1 percent vs. 16.9 percent), and reduced rates of stent thrombosis (0.4 vs. 1.5 percent). 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 percent) as well as a trend toward fewer stent thromboses (0 vs. 0.7 percent).
For more information: www.bostonscientific.com
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