The TAXUS Liberté coronary stent system will be the next generation to Boston Scientific's market-leading paclitaxel-eluting coronary stent system, TAXUS® Express2™. The Liberté stent features the Veriflex™ stent design, a highly flexible cell geometry with thin struts and uniform cell distribution. This new platform has been designed to offer improved deliverability and conformability in challenging anatomy. It also features the enhanced TrakTip™ catheter tip, mounted on the Maverick2™ delivery catheter, designed to provide better lesion crossability. In addition, TrakTip has a low lesion-entry profile, also intended to further improve crossability.
The registry will enroll patients in five phases, corresponding to the commercial introduction of the TAXUS Liberté system in different regions of the world. The first, or transitional, phase involved the enrollment of 500 patients from a limited number of international markets in which Boston Scientific launched the TAXUS Liberté system in January 2005. This initial phase, for which enrollment was just completed, will be followed by enrollment of approximately 30,000 patients from a broader number of international markets and European markets beginning this summer. The final U.S. phases are expected to start enrollment in 2006.
"We are very pleased that the OLYMPIA registry has reached this important enrollment milestone and is on track to become the world's largest drug-eluting stent registry," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "OLYMPIA will provide valuable data about the real-world performance of our TAXUS Liberté coronary stent system, the first next-generation drug-eluting stent system."
The Company received the CE Mark for the bare-metal Liberté stent system in December 2003 and plans to launch the TAXUS (drug-eluting) Liberté system in Europe this year. In April 2004, the Company received U.S. Food and Drug Administration (FDA) approval for its Liberté™ bare-metal coronary stent system. Boston Scientific has completed enrollment in its ATLAS clinical trial, a pivotal study designed to support FDA approval of the TAXUS Liberté stent system, and anticipates FDA approval next year.
The OLYMPIA registry was formerly known as the OLYMPIC registry.
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 clinical trials, the regulatory approval process, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.