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Boston Scientific Announces FDA Approval and Launch of Liberte™ Coronary Stent System |
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Technology serves as next-generation
platform for Company's market-leading
TAXUS® paclitaxel-eluting coronary stent system |
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NATICK, Mass., April 14 -- Boston Scientific Corporation (NYSE: BSX - News) today announced that it has received U.S. Food and Drug Administration (FDA) approval for its Liberte™ bare-metal coronary stent system. The Company plans to launch the product immediately in the United States. The Liberte stent serves as the platform for Boston Scientific's next- generation paclitaxel-eluting stent system, TAXUS® Liberte™. The Company 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, where it has experienced strong reception and has been praised by clinicians for its deliverability and ease of use. In the U.S., Boston Scientific has completed enrollment in its ATLAS clinical trial, a pivotal study designed to support FDA approval of the TAXUS Liberte stent system, and anticipates FDA approval in mid-2006. Boston Scientific's first paclitaxel-eluting coronary stent system, TAXUS® Express2™, is the worldwide leader in the coronary stent market today. "Approval of the Liberte coronary stent system is a significant development in the evolution of our coronary stent program," said Paul LaViolette, Boston Scientific Chief Operating Officer. "This new state-of- the-art technology, featuring enhanced conformability and deliverability, is another step forward in helping clinicians treat coronary artery disease. As the future platform for our TAXUS stent system, the Liberte stent demonstrates Boston Scientific's commitment to providing new and innovative treatment options." The Liberte stent features Veriflex™ stent design, a highly flexible cell design with thin struts for enhanced deliverability in challenging anatomy as well as the TrakTip™ catheter tip used with the Maverick2™ delivery catheter, which provides improved lesion 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: http://www.bostonscientific.com. This press release contains forward-looking statements. The Company wishes to caution the reader 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 the regulatory process, introduction of new products, intellectual property, litigation, competitive product offerings and other factors described in the Company's filings with the Securities and Exchange Commission.
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