Healthcare Industry News: XIENCE
News Release - September 5, 2006
SPIRIT II Results Highlight Strength of Boston Scientific Stent PortfolioInternational data suggests low revascularization rates for both TAXUS stent and PROMUS(TM) (XIENCE(TM) V) stent
NATICK, Mass. and BARCELONA, Spain, Sept. 5 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed the results of Abbott's SPIRIT II clinical trial, which reaffirmed the safety and efficacy of the market-leading TAXUS® stent, and provided promising data on Abbott's XIENCE(TM) V Everolimus-Eluting Coronary Stent System (which will be marketed by Boston Scientific as the PROMUS(TM) Stent*). Designed as a non-inferiority trial, SPIRIT II is the first head-to-head randomized trial of two different drug-eluting stents in which one company will market both products. Results were presented at the annual European Society of Cardiology/World Congress of Cardiology 2006 in Barcelona, Spain.
"SPIRIT II adds to the extensive body of clinical evidence from randomized trials that reinforce the excellent safety and efficacy of the TAXUS Stent System, and provides solid traction for growth of the PROMUS Stent," said Jeff Goodman, President of Boston Scientific International. "The TAXUS Stent continues to demonstrate exceptional deliverability and the proven clinical outcomes that make it the leading drug-eluting stent in virtually every market where we offer the product."
After presenting the data, Prof. Patrick Serruys, the principal investigator of the trial, stated "While PROMUS met the trial's primary non- inferiority end point of in-stent late loss, larger confirmatory trials will be required to validate the safety and effectiveness shown to date."
SPIRIT II is a randomized, multi-center, non-inferiority trial designed to evaluate the XIENCE(TM) V Everolimus-Eluting Coronary Stent System, manufactured and sold by Abbott, and marketed by Boston Scientific as the PROMUS Stent, against the TAXUS® Express2(TM) Paclitaxel-Eluting Coronary Stent System in the treatment of coronary artery disease. The primary endpoint was in-stent late loss at six months. The study reported an in-stent late loss of .11mm for the XIENCE V Stent, and .36mm for the TAXUS Stent, which is consistent with TAXUS Stent results in previous trials. Secondary endpoints included Ischemia-Driven Target Lesion Revascularization (TLR), which was 1.8% for the XIENCE V Stent and 3.9% for the TAXUS Stent.
About Boston Scientific
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, operational improvements, and other factors described in the Company's filings with the Securities and Exchange Commission.
* PROMUS(TM) Stent: CE Mark pending. Not available for sale in the European Economic Area. Not for use or distribution in the United States.
Source: Boston Scientific
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