Healthcare Industry News: TAXUS Express2
News Release - March 26, 2009
Boston Scientific Announces Schedule For ACC 2009NATICK, Mass., March 26 (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE: BSX ) today announced the schedule of the Company's major events and news announcements at the 58th Annual Scientific Session of the American College of Cardiology / i2 Summit, which runs from March 28-31 in Orlando, Florida.
"We are pleased to be announcing additional analyses of one-year data from the landmark SYNTAX study, the only randomized trial of its kind to provide physicians with critical data on the performance of drug-eluting stents in patients with left main and three-vessel disease," said Keith D. Dawkins, M.D., Senior Vice President and Associate Chief Medical Officer at Boston Scientific. "We expect results will offer further insight into this complex patient population."
Schedule of Events (all times are Eastern Time)
Saturday, March 28
- SYNTAX Quality of Life and Economic Outcomes. David J. Cohen, M.D., will present an analysis of one-year data from the SYNTAX trial titled "Health Related Quality of Life and U.S. Based Economic Outcomes of PCI With Drug-Eluting Stents Versus Bypass Surgery for Patients with Three-Vessel and Left Main Coronary Artery Disease." SYNTAX is the first randomized, controlled clinical trial comparing percutaneous coronary intervention (PCI) using drug-eluting stents (DES) to coronary artery bypass graft (CABG) surgery in patients with left main (LM) and/or three-vessel disease (3VD). The results will be presented at 8:50 a.m. during a late-breaking trial session in Ballroom W415. The Company plans to issue a press release at this time.
- PROMUS® and TAXUS® Stents. During a poster session from 9:30-10:30 a.m. in West Hall D, three-year results from the SPIRIT II Clinical Trial will be presented by Patrick W. Serruys, M.D., Ph.D. In the same session, Yoshinobu Onuma, M.D., will present results from a pooled analysis of two-year clinical follow-up from the SPIRIT II and III Trials. SPIRIT II was a randomized, non-inferiority trial of 300 patients used to support U.S. Food and Drug Administration (FDA) approval of the XIENCE V(TM) (PROMUS®) Stent. SPIRIT III was a randomized, non-inferiority trial of 1,002 patients designed to obtain U.S. FDA approval for the XIENCE V (PROMUS) Stent. The Company plans to issue a press release at this time.
- Effect of Gender in SYNTAX Trial. Marie-Claude Morice, M.D., will evaluate the effect of gender on one-year outcomes following CABG and PCI in complex patients with left main and/or three-vessel disease from the SYNTAX trial. Results will be presented from 9:30-10:30 a.m. during a poster session in West Hall D.
- Effect of Age in SYNTAX Trial. Antonio Colombo, M.D., will discuss the impact of age on one-year outcomes in complex patients from the SYNTAX trial. Results will be presented from 9:30-10:30 a.m. during a poster session in West Hall D.
- TAXUS V ISR Results. Stephen G. Ellis, M.D., will present three-year results from the TAXUS V In-Stent Restenosis (ISR) clinical trial, which evaluates the TAXUS Express2(TM) paclitaxel-eluting coronary stent system versus vascular brachytherapy for the treatment of bare-metal stent in-stent restenosis. Results will be presented from 9:30-10:30 a.m. during a poster session in West Hall D.
- Utility of DES Registries. John M. Lasala, M.D., will compare data from the 7,492-patient TAXUS ARRIVE Registries to outcomes from the TAXUS and HORIZONS-AMI randomized clinical trials in order to evaluate how a high-quality registry can provide rigorous and reliable data when analogous randomized controlled trial data are not available. Results of the analysis will be presented from 3:30-4:30 p.m. during a poster session in West Hall D.
- Effect of Gender in ARRIVE Registries. Dr. Lasala will present an analysis of gender-specific outcomes at two years in 7,492 patients from the ARRIVE Registries designed to understand the possible effects of gender in an unselected population treated with the TAXUS Express Stent. Results of the analysis will be presented from 3:30-4:30 p.m. during a poster session in West Hall D.
- Cardiac Rhythm Management Symposium. From 7:00-9:00 p.m., the Company will sponsor a symposium titled "Working in Concert to Slow the Progression of Heart Failure: Medical and Device Management Strategies," chaired by David S. Cannom, M.D., in Ballroom D/E of the Rosen Centre Hotel. The symposium will offer a discussion on the latest in medical management and device management in treating heart failure, and will include panel members Gary Francis, M.D., Barry H. Greenberg, M.D., Gregg C. Fonarow, M.D., and Helmut Klein, M.D. A reception will be held prior to the symposium at 6:00 p.m.
- OLYMPIA Real World Stenting Outcomes. Oscar A. Mendiz, M.D., will present an analysis of the safety and performance of the TAXUS Liberte® Stent in patients with left main and three-vessel disease from the TAXUS OLYMPIA study. OLYMPIA is a multi-center, post-approval registry capturing outcomes in 22,483 patients from 57 countries treated with the TAXUS Liberte paclitaxel-eluting stent in real world routine interventional cardiology practice. One-year follow-up data are available for 692 patients with LM and 278 patients with 3VD stenting. Results will be presented at 2:45 p.m. during an oral presentation session in Room W414D.
- ARRIVE Very Late Stent Thrombosis Predictors. Kenneth W. Baran, Jr., M.D., will present an analysis of a clinical risk score for prediction of very late stent thrombosis (VLST) in DES patients. Using data from the TAXUS ARRIVE 1 and 2 stent registries, six significant baseline predictors of VLST were identified to help facilitate long-term management of patients following DES placement. Results of the analysis will be presented from 9:30-10:30 a.m. during a poster session in West Hall D.
- Cardiovascular Symposium. From 7:00-9:00 p.m., the Company will sponsor a symposium titled "Complex Lesions and the Dynamics of Patient Care," chaired by Ted E. Feldman, M.D., in Ballroom D/E of the Rosen Centre Hotel. The symposium will offer a discussion on the latest clinical data for patients with complex lesions, and will include panel members Martin B. Leon, M.D., Dean J. Kereiakes, M.D., Frederick W. Mohr, M.D., and David J. Cohen, M.D. A reception will be held prior to the symposium at 6:00 p.m.
TAXUS, Express, Express2, Liberte and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE V is a trademark of Abbott Laboratories group of companies. The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The SPIRIT Clinical Program is sponsored by Abbott. The TAXUS Express Stent was the control in the SPIRIT III trial and both the TAXUS Express Stent (59 patients) and the TAXUS Liberte Stent (17 patients) were used as controls in the SPIRIT II trial.
The safety and effectiveness of the TAXUS Express and TAXUS Liberte stents have not been established in patients with left main or multi-vessel disease.
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, scientific activities, product performance, competitive offerings and growth strategies. 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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