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Boston Scientific Announces Enrollment of First Patient in Clinical Trial for Next-Generation Paclitaxel-Eluting Coronary Stent System |
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Pivotal study will assess safety and efficacy of TAXUS™ Liberte™
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NATICK, Mass., Aug. 26 -- Boston Scientific Corporation (NYSE: BSX - News) today announced that enrollment has begun in its ATLAS clinical trial. ATLAS is the first trial using Boston Scientific's new Liberte™ coronary stent as a platform for its paclitaxel-eluting coronary stent system. TAXUS™ Liberte™ will be the next generation to Boston Scientific's current paclitaxel-eluting coronary stent system, TAXUS™ Express2™. The Liberte stent, which has been designed to further enhance deliverability and conformability, particularly in challenging lesions, is currently available in international markets in a bare metal version. The ATLAS trial is a pivotal study to collect data to support regulatory filings for product commercialization. It is designed to assess the safety and efficacy of a slow-release dose formulation paclitaxel-eluting TAXUS Liberte stent system for the treatment of coronary artery disease. The first patient was enrolled at Washington Adventist Hospital in Takoma Park, Maryland. ATLAS, a global, multicenter clinical trial, is scheduled to enroll 822 patients at 60 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan. The Company received approval last month from the U.S. Food and Drug Administration to begin the trial. "I have been impressed by the flexibility and maneuverability of the Liberte stent system," said Mark A. Turco, M.D., F.A.C.C., Director, Center for Cardiac and Vascular Research, Washington Adventist Hospital, and Co- Principal Investigator for the ATLAS study. "We are hopeful that this new stent design will provide an even better delivery platform for paclitaxel that will allow us to expand the utilization of this therapy to a broader patient base." 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: http://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.
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