Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Les... (vessel in-stent restenosis and major adv...)

Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents

Date:2/5/2009

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.

"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%, 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).

"We are pleased to have a second-generation small vessel DES and the U.S. market's first long DES under review by the FDA," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "The rapid adoption of our recently approved TAXUS Express Atom Stent confirms the need for an expanded DES size matrix to treat the wide range of vessel anatomies seen in daily clinical practice."

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SOURCE Boston Scientific Corporation
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