Boston Scientific Completes Enrollment for ATLAS Trial
Boston Scientific has completed enrollment in its ATLAS clinical trial, a global, multicenter, pivotal study designed to support FDA approval of the Taxus Liberte stent system.
The trial is assessing the safety and efficacy of a slow-release dose formulation paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease. ATLAS has enrolled 872 patients at 72 sites in the U.S., Canada, Australia, New Zealand, Singapore and Hong Kong. The primary endpoint for the study is target vessel revascularization at nine months.
Boston Scientific received the CE Mark for the bare metal Liberte stent system in December 2003 and plans to launch the Taxus Liberte system in Europe later this year. The Taxus Liberte system was launched in 18 other international markets in January.