Healthcare Industry News: stent thrombosis
News Release - September 4, 2007
Five-Year Data From Taxus II Clinical Trial Highlights Safety and Efficacy of Taxus(R) Stent Compared to Bare-Metal StentTAXUS(R) Stent shows no additional very late stent thrombosis
NATICK, Mass. and VIENNA, Austria, Sept. 4 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced five-year and final results from its TAXUS II clinical trial, demonstrating continued long-term safety and efficacy for the TAXUS® paclitaxel-eluting stent system. Among the findings, the TAXUS stent showed no additional stent thrombosis between years four and five, while the bare-metal control experienced one stent thrombosis during this same period. This marks the third consecutive year of TAXUS II follow-up with no stent thrombosis seen in the TAXUS stent patient group. The Company made the announcement at the annual European Society of Cardiology Congress in Vienna, Austria.
"Long-term results from TAXUS II reinforce the safety of paclitaxel- eluting stent technology and provide encouraging data regarding late and very late stent thrombosis out to five years," said Prof. Sigmund Silber, M.D., F.A.C.C., F.E.S.C., who presented the TAXUS II results at ESC 2007. "In this trial, the data revealed that the TAXUS paclitaxel-eluting stent maintained its efficacy benefits and had no thrombosis between years four and five while the bare-metal control had one additional thrombosis. These results warrant important consideration and possible further study if seen as an indication of longer term trends."
The efficacy advantage of the TAXUS Stent seen at six months was maintained through the five years following stent implantation, with the commercialized slow-release (SR) version of the TAXUS Stent reducing Target Lesion Revascularization (TLR) by 44 percent versus bare-metal stents (TAXUS SR 10.3%, BMS 18.4%, p=0.0003). Safety of the TAXUS stent was also maintained with Major Adverse Cardiac Events (MACE) for the TAXUS SR stent showing a 35 percent reduction over the bare-metal control stent (TAXUS SR 20.4%, BMS 27.6%, p=0.01). The overall myocardial infarction (MI) rate for the TAXUS SR stent was 4.7 percent as compared to 7.1 in the bare-metal group (TAXUS SR 4.7%, BMS 7.1%, p=NS).
"We are pleased that the TAXUS II results continue to support the proven safety and efficacy profile of the TAXUS paclitaxel-eluting stent system and that the benefits of the TAXUS Stent are maintained over the long term," said Jeff Goodman, President of Boston Scientific International. "The TAXUS II five-year data shows continued durability with low rates of MI and TLR, demonstrating the long-term therapeutic advantage of TAXUS."
TAXUS II is a randomized, double-blind, controlled study of 536 patients in 15 countries designed to evaluate the safety and efficacy of a TAXUS paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations.
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 IA- 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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