Healthcare Industry News: SPIRIT II
News Release - October 22, 2007
Boston Scientific PROMUS(TM) and TAXUS(R) Stents Continue Strong Performance in Safety and Efficacy MeasuresNATICK, Mass., and WASHINGTON, Oct. 22 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed results from the SPIRIT III Clinical Trial, which continue to support the proven safety and efficacy of the market-leading TAXUS® Express2(TM) Paclitaxel-Eluting Coronary Stent System and add to the growing body of strong clinical evidence for the XIENCE(TM) V (PROMUS(TM)) Everolimus Eluting Coronary Stent System. An analysis of the data was presented 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, during a late- breaking trial session at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
One-year results from the SPIRIT III trial included an updated analysis of 1,002 patients with coronary artery disease treated with either the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. Ischemia-driven target lesion revascularization (TLR) for 669 patients treated with the XIENCE V (PROMUS) Stent changed from 2.6% to 3.3% between nine months and one year, while for the 333 patients treated with the TAXUS Stent, TLR changed from 5.0% to 5.6% during the same time period, still failing to reach statistical significance (p=0.09). Target vessel revascularization (TVR) at one year was also similar, with 6.1% for PROMUS and 7.5% for TAXUS (p=0.41).
The overall MACE (Major Adverse Cardiac Events) rate (defined as cardiac death, myocardial infarction (heart attack, or MI) or ischemia-driven TLR) through one year was 5.8% for the XIENCE V (PROMUS) Stent and 9.9% for the TAXUS Stent (p=0.01), reflecting an increased number of small (non-Q wave) MIs at the time of the procedure (2.5% vs. 3.8%).
Subset analysis showed especially strong performance of the TAXUS Stent in diabetic patients with MACE rates remaining low at 4.7%, while MACE rates increased in the XIENCE V (PROMUS) Stent to 8.8%. In long lesions (lesion length>13.2 mm), MACE was 7.7% for the XIENCE V (PROMUS) Stent and 8.0% for the TAXUS Stent; in small vessels (RVD< / =2.775 mm), 6.1% for the XIENCE V (PROMUS) Stent and 12.1% for the TAXUS Stent*.
Stent thrombosis rates through one year were also low for both the TAXUS Stent (0.6%, 0.6%) and the XIENCE V (PROMUS) Stent (0.8%, 1.1%), using protocol and ARC definitions, respectively.
"The SPIRIT III one-year data reaffirms the proven long-term outcomes of the TAXUS Stent," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We look forward to launching the PROMUS Stent in the U.S., which will complement our paclitaxel-eluting TAXUS Stent by offering physicians a deliverable Olimus option."
The PROMUS Stent has CE Mark approval and is distributed in most European countries and other international markets. The 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. The safety and efficacy of the TAXUS Express2 Stent System have not been established in patients with diabetes, long lesions and small vessels.
SPIRIT is sponsored by Abbott. TAXUS, Express2 and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.
*Subsets were not designed for statistical comparisons and demonstrated the above observational results.
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.
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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