Healthcare Industry News: SPIRIT II
News Release - May 13, 2008
SPIRIT III Results Reaffirm Strong Performance of Boston Scientific PROMUS(TM) and TAXUS(R) Express(R) StentsNATICK, Mass. and BARCELONA, Spain, May 13 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed two-year results from the SPIRIT III clinical trial, which continue to reaffirm the proven long-term safety and efficacy of the market-leading TAXUS® Express2(TM) Paclitaxel-Eluting Coronary Stent System and reinforce the growing body of positive clinical evidence for the XIENCE(TM) V (PROMUS(TM)) Everolimus-Eluting Coronary Stent System. The results were presented at the 2008 EuroPCR Scientific Program in Barcelona by Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation in New York, and the Principal Investigator of the SPIRIT III Trial.
The results demonstrated comparable safety and efficacy rates through two years for the XIENCE V (PROMUS) and TAXUS Express Stents. The Ischemia-Driven Target Lesion Revascularization (TLR) rate for the XIENCE V (PROMUS) Stent was 4.3% while the TAXUS Express Stent was 6.9% (p=0.07). The overall Major Adverse Cardiac Event, (MACE a composite endpoint of Cardiac Death, Myocardial Infarction and TLR) rate was 7.3% for the XIENCE V (PROMUS) Stent and 12.8% for the TAXUS Express Stent (p=0.004). In addition, stent thrombosis rates using the ARC (Academic Research Consortium) definite/probable definition were low for the XIENCE V (PROMUS) and the TAXUS Express Stents (1.3% and 1.7%, p=0.77).
"We are very pleased that both the TAXUS Express and PROMUS Stents continue to perform so well in the SPIRIT III trial, adding to the extensive body of clinical evidence reinforcing the excellent safety and efficacy of the market-leading TAXUS Stent and the growing body of positive clinical evidence for the PROMUS Stent at two years," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "With the anticipated FDA approval of the XIENCE V (PROMUS) Stent and the launch of the TAXUS Liberte Stent this year, we are excited to offer physicians and their patients two drugs on two highly deliverable platforms."
The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The PROMUS and TAXUS Liberte® Stents have received CE Mark approval and are distributed in most European countries and other international markets. The XIENCE V (PROMUS) Stent is an investigational device in the U.S. and not yet approved for sale. It is currently under FDA review with an anticipated U.S. launch in 2008.
SPIRIT III is sponsored by Abbott. TAXUS, TAXUS Express2, Express, Liberte and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A -- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A -- Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific
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