Healthcare Industry News: SPIRIT II
News Release - October 16, 2006
Boston Scientific Becomes only Company with Two Drug-Eluting Stent Platforms With European Approval of Everolimus-Eluting PROMUS(TM) Stent SystemPROMUS stent to complement Company's market-leading TAXUS(R) stent systems
NATICK, Mass., Oct. 16 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) announced today that the PROMUS(TM) Everolimus-Eluting Coronary Stent System has received CE Mark approval, making Boston Scientific the only company to offer two distinct approved drug-eluting stent (DES) platforms in the CE geographies. This approval allows Boston Scientific to begin marketing the new drug-eluting stent system in the 25 countries of the European Union and will support market registrations in other regulated countries in Asia, Latin America and Eastern Europe.
The PROMUS Stent is a private-labeled XIENCE(TM) V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. It will complement Boston Scientific's market-leading TAXUS® paclitaxel-eluting stent systems. The Company expects to launch the PROMUS stent in Europe in 2007.
"We are very pleased that CE Mark approval has been granted for this important expansion of our drug-eluting stent portfolio," said Paul LaViolette, Boston Scientific Chief Operating Officer. "Boston Scientific is proud to be able to offer clinicians the choice of a paclitaxel-eluting stent and an everolimus-eluting stent from the same company, for the first time. We look forward to complementing the proven safety and efficacy of TAXUS with the tremendous potential of PROMUS, further demonstrating the breadth and depth of our DES pipeline as well as our overall leadership in supplying innovative products to interventional cardiologists."
Boston Scientific's TAXUS stent system has a record of proven outcomes, including more than three million TAXUS stents implanted in patients worldwide and clinical follow-up on nearly 3,500 patients out to four years in TAXUS randomized, controlled clinical trials. Positive results for the XIENCE(TM) V stent were reported from the SPIRIT II clinical trial at the recent World Congress of Cardiology in Barcelona, Spain, showing that the XIENCE(TM) V stent met its primary endpoint of non-inferiority to TAXUS as measured by late loss at six months.
PROMUS, LIBERTE, TAXUS and Express2 are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott. The SPIRIT Clinical Program is sponsored by Abbott Vascular. PROMUS is not approved for sale in the U.S.
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. Boston Scientific 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 new product development, supply and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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