The ATLAS trial is a global, multicenter pivotal study designed to support U.S. Food and Drug Administration approval of the TAXUS Liberté stent system. It is assessing the safety and efficacy of a slow-release dose formulation paclitaxel-eluting TAXUS Liberté stent system for the treatment of coronary artery disease. ATLAS has enrolled 872 patients at 72 sites in the United States, Canada, Australia, New Zealand, Singapore and Hong Kong. The primary endpoint for the study is target vessel revascularization at nine months. Enrollment began in August 2004. In addition to the ATLAS trial, the TAXUS Liberté program includes several expansion studies for long lesion stenting, small vessel stenting and direct stenting of coronary lesions. The expansion studies are expected to begin enrollment in the next several weeks.
The Company received the CE Mark for the bare metal Liberté stent system in December 2003 and plans to launch the TAXUS Liberté system in Europe later this year. The TAXUS Liberté system was launched in 18 other international markets in January.
"I am very pleased that enrollment has concluded in this pivotal study so quickly," said John Ormiston, M.D., Interventional Cardiologist, Mercy Hospital and Green Lane Cardiovascular Unit, Auckland, New Zealand, and Co-Principal Investigator of the ATLAS study. "We are excited about the potential for the new Liberté stent design to provide clinicians easier access to vessels indicated for drug-eluting stent treatment."
The Liberté stent features the Veriflex™ stent design, a highly flexible cell geometry with thin struts and uniform cell distribution. This new platform offers improved deliverability and conformability in challenging anatomy. It also features the enhanced TrakTip™ catheter tip, mounted on the Maverick2™ delivery catheter, which provides better lesion crossability. In addition, TrakTip has a low lesion-entry profile, which further improves crossability.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with commercialization of new technologies, competitive offerings, intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.