Healthcare Industry News: PROMUS
News Release - March 31, 2008
Spirit II Results Support Strength of Boston Scientific's Two Drug-Eluting Stent PlatformsAt two years, Company's TAXUS(R) and PROMUS(TM) Stents demonstrate positive and similar outcomes
NATICK, Mass. and CHICAGO, March 31 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed positive two-year results from Abbott's prospective, randomized (3:1), single blind, non-inferiority SPIRIT II Trial comparing the safety and efficacy of the XIENCE(TM) V (PROMUS(TM)) Everolimus-Eluting Coronary Stent and Boston Scientific's worldwide market-leading TAXUS® Express2(TM) Paclitaxel-Eluting Coronary Stent System ("TAXUS Stent") in 300 patients in Europe. The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. Boston Scientific is the only company offering two distinct drugs on two deliverable platforms - the TAXUS and PROMUS Stents. The results were presented today at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago by Professor Patrick Serruys, M.D., Ph.D., Chief of Interventional Cardiology, Thoraxcenter-Erasmus University Rotterdam, The Netherlands, and the SPIRIT II Principal Investigator.
At two years, results from the SPIRIT II trial demonstrated no numerical difference between the XIENCE V (PROMUS) Stent and the TAXUS Stent in their angiographic outcomes, nor were there statistically significant differences in the clinical outcomes. The cardiac death rate for the XIENCE V (PROMUS) Stent was 0.5 percent and for the TAXUS Stent was 1.4 percent (p=0.45). Myocardial infarction (MI) rates for the XIENCE V (PROMUS) Stent and the TAXUS Stent were 2.8 percent and 5.5 percent (p=0.29), respectively. Ischemia-driven target lesion revascularization (ID-TLR) rates were comparable, at 3.8 percent for the XIENCE V (PROMUS) Stent and 6.8 percent for the TAXUS Stent (p=0.33). Major adverse cardiac events (MACE) rates comprised of cardiac death, all MI and ID-TLR were also comparable, at 6.6 percent for the XIENCE V (PROMUS) Stent and 11.0 percent for the TAXUS Stent (p=0.31).
Stent thrombosis rates at two years using the Academic Research Consortium (ARC) definite/probable definition were low for both the XIENCE V (PROMUS) Stent (0.9%) and the TAXUS Stent (1.4%). Angiographic outcomes showed numerically equivalent late loss, with 0.33 mm for XIENCE V (PROMUS) and 0.34 mm for TAXUS (p=0.60). In-stent binary restenosis rates at two years were also comparable for the XIENCE V (PROMUS) Stent and the TAXUS Stent (2.1% vs. 2.9%, p=1.0).
"Boston Scientific's two DES platforms - the TAXUS and PROMUS Stents - both performed extremely well in the SPIRIT II Trial out to two years," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "The data, once again, demonstrated impressive safety and efficacy profiles with low stent thrombosis rates and similar clinical outcomes. We look forward to future data from the SPIRIT Clinical Trial Program as well as from our PROENCY Registries in Europe and the United States - the first to observe different 'Olimus-eluting coronary stents in a real-world setting."
In February, Boston Scientific announced that the first patient had been enrolled in its PROENCY (PROMUS(TM), ENdeavor® and CYpher®) European Registry. The registry will collect real-life clinical outcome data for the PROMUS Stent and compare them with data from Johnson & Johnson's Cypher® Sirolimus-Eluting Stent and Medtronic's Endeavor® Zotarolimus-Eluting Stent in patients in routine clinical practice. A U.S. PROENCY Registry is expected to begin enrolling patients in July and complete enrollment by the end of 2008.
The XIENCE(TM) V (PROMUS) Stent is currently pending approval by the U.S. Food and Drug Administration (FDA), which is expected to occur in the first half of 2008. Upon FDA approval of the PROMUS Stent, Boston Scientific will immediately make it available for sale in the United States.
The PROMUS Stent is an investigational device in the U.S. and not yet approved for sale. The PROMUS Stent is currently for sale in Europe and certain other international markets. TAXUS and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of the Abbott Laboratories group of companies. The SPIRIT Clinical Program is sponsored by Abbott.
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: www.bostonscientific.com.
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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, competitive offerings, procedural volume, overall market size and our market position. 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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