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Boston Scientific will be announcing a wide range of safety and efficacydata on its TAXUS(R) Express2(TM) and second-generation TAXUS(R) Liberte(R)Paclitaxel-Eluting Coronary Stent Systems, including 12-month subset data onpatients with left main (LM) and three-vessel disease (3VD) from the SYNTAXtrial, which compares percutaneous coronary intervention (PCI) using the TAXUSExpress2 Stent System to coronary artery bypass graft (CABG) surgery in thesemost complex patient groups. In addition, the Company will present two-yearresults from the ARRIVE diabetic subset analysis (TAXUS Express Stent),three-year data from the ATLAS Workhorse and Direct Stenting trials andtwo-year ATLAS data on small vessels and long lesions (TAXUS Liberte Stent).
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"We are pleased to be announcing new subset data on left main andthree-vessel disease patients from the landmark SYNTAX study, the onlyrandomized trial of its kind to provide physicians with critical data on theperformance of drug-eluting stents (DES) in these very difficult patientpopulations," said Keith D. Dawkins, M.D., Senior Vice President and AssociateChief Medical Officer at Boston Scientific. "We also plan to presentadditional detail on the SYNTAX Score -- a new scientific measure foranatomical complexity designed to provide guidance to physicians is assessingtreatment options for LM and 3VD patients."
-- TAXUS ATLAS Workhorse, Direct Stenting, Small Vessel and Long Lesionstudies. Three-year data from the TAXUS ATLAS Workhorse study and two-yeardata from the TAXUS ATLAS Direct Stent study will be presented by the study'sco-principal investigator Mark A. Turco, M.D., in an e-poster session titled"TAXUS ATLAS and TAXUS ATLAS DIRECT STENT Trials: Durable Effectiveness of theTAXUS Liberte Stent and Long-Term Benefit of Direct Stenting". In addition,two-year data from the TAXUS ATLAS Small Vessel and Long Lesion studies willbe presented by John A. Ormiston, M.D., in an e-poster session titled "DurableBenefit of TAXUS Liberte vs. TAXUS Express in Small Vessels and Long Lesionsin the TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION Trials". TAXUSATLAS is a global, multi-center, single-arm study designed to demonstrate thatthe TAXUS Liberte Stent is non-inferior in safety and efficacy to the TAXUSExpress Stent. The Company plans to issue a press release at this time.
-- TAXUS ARRIVE diabetic data. A diabetic sub-group analysis from theTAXUS ARRIVE registry will be presented by John M. Lasala, M.D., PhD, in ane-poster session titled "TAXUS Mitigates the Effect of Diabetes on RestenosisIndependent of Patient Risk Profile: Two-Year Results from the TAXUS ARRIVEProgram". The ARRIVE program is designed to collect and analyze "real-world"safety and clinical outcomes data from the TAXUS Express2 Paclitaxel-ElutingCoronary Stent System in the treatment of patients with coronary arterydisease. The Company plans to issue a press release at this time.
Tuesday, October 14
-- SYNTAX Study subset data. The latest 12-month outcomes subset datafrom the SYNTAX trial will be presented by Principal Investigators Patrick W.Serruys, M.D., Ph.D., and Friedrich W. Mohr, M.D., beginning at 11:10 a.m. inthe Main Arena of the Washington Convention Center. Dr. Serruys will presenta Featured Lecture on "Revascularization in Patients with Unprotected LeftMain Coronary Artery Disease," while Dr. Mohr will present on"Revascularization in Patients with Triple Vessel Coronary Artery Disease."SYNTAX is the first randomized, controlled clinical trial comparing PCI usingdrug-eluting stents to CABG in patients with left main and/or three-vesseldisease. The Company plans to issue a press release at this time. Dr.Serruys will present additional details on the SYNTAX Score during hisFeatured Lecture as well as during Tuesday's Focus on SYNTAX Sessions in apresentation titled "SYNTAX Score: Methodology and Importance."
-- Focus on SYNTAX. From 2:00 -- 6:00 p.m., a series of focus sessionstitled "Revascularization for Left Main and Triple-Vessel Disease: Focus onSYNTAX" will take place in Room 147AB. Details on the topics and presenterscan be found in the official TCT program.
-- Symposium on SYNTAX Trial Data. From 8:00 -- 10:00 p.m., the Companywill sponsor a symposium entitled "The SYNTAX Trial: Understanding the Data inComplex Anatomies and Advanced Disease," chaired by Dr. Serruys in the GrandBallroom of the Renaissance Hotel. The symposium will offer an overview ofthe latest SYNTAX trial data and feature a panel discussion on subset casepresentations for patients with multi-vessel disease and left main disease.The symposium will include panel members Ted E. Feldman, M.D., Michael J.Mack, M.D., Martin B. Leon, M.D., and Friedrich W. Mohr, M.D. A receptionwill be held prior to the symposium at 7:00 p.m.
Wednesday, October 15
-- OLYMPIA High-Risk Subgroups. One-year results from Intercontinentaland European Launch Phases of the global OLYMPIA registry will be presented inan oral abstract session by Waqar H. Ahmed, M.D., M.S., FACC, at 8:41 a.m., inRoom 145AB. OLYMPIA is the world's largest prospective, multi-center,multi-phased registry for a single drug-eluting stent. The registry isdesigned to analyze real-world clinical outcomes data for Boston Scientific'ssecond-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System.Results from more than 22,000 patients will focus on safety and efficacy, andwill highlight outcomes within high-risk lesion subgroups and patients withserious co-morbid conditions. The Company plans to issue a press release atthis time.
-- HORIZONS AMI data. At 11:00 a.m., Gregg W. Stone, M.D., will presentdata from the featured trial of the day "HORIZONS AMI: A ProspectiveRandomized Trial of Paclitaxel-Eluting Stents vs. Bare-Metal Stents inPatients with Acute ST-Segment Elevation Myocardial Infarction" in the MainArena. The HORIZONS AMI trial is a randomized, controlled clinical trialdesigned to compare TAXUS stents to bare-metal stents in 3,400 AMI (acutemyocardial infarction) patients. The Company plans to issue a press releaseat this time.
-- SYNTAX Sessions. From 10:15 a.m. -- 12:30 p.m., an additional seriesof sessions moderated by Dean J. Kereiakes, M.D., and Craig R. Smith, M.D.,titled "Coronary Artery Disease I: Revascularization Controversies" will occurin Room 206. Details on the topics and presenters can be found in theofficial TCT program.
Boston Scientific will present its latest innovations at booth 814 onLevel 2 of the Exhibition Hall, including the TAXUS(R) Express2(TM) Atom(TM)Paclitaxel-Eluting Coronary Stent System, which recently became the only DESapproved by the FDA for use in vessels as small as 2.25 mm in diameter.
The safety and effectiveness of the TAXUS Express Stent has not beenestablished in patients with left main, three vessel disease, or an acute MI.In the U.S., the TAXUS Liberte Stent is an investigational device and is notavailable for sale.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements may be identified by words like "anticipate," "expect," "project,""believe," "plan," "estimate," "intend" and similar words. Theseforward-looking statements are based on our beliefs, assumptions and estimatesusing information available to us at the time and are not intended to beguarantees of future events or performance. These forward-looking statementsinclude, among other things, clinical trials, regulatory approvals, productperformance and competitive offerings. If our underlying assumptions turn outto be incorrect, or if certain risks or uncertainties materialize, actualresults could vary materially from the expectations and projections expressedor implied by our forward-looking statements. These factors, in some cases,have affected and in the future (together with other factors) could affect ourability to implement our business strategy and may cause actual results todiffer materially from those contemplated by the statements expressed in thispress release. As a result, readers are cautioned not to place undue relianceon any of our forward-looking statements.
Factors that may cause such differences include, among other things:future economic, competitive, reimbursement and regulatory conditions; newproduct introductions; demographic trends; intellectual property; litigation;financial market conditions; and, future business decisions made by us and ourcompetitors. All of these factors are difficult or impossible to predictaccurately and many of them are beyond our control. For a further list anddescription of these and other important risks and uncertainties that mayaffect our future operations, see Part I, Item IA- Risk Factors in our mostrecent Annual Report on Form 10-K filed with the Securities and ExchangeCommission, which we may update in Part II, Item 1A -- Risk Factors inQuarterly Reports on Form 10-Q we have filed or will file thereafter. Wedisclaim any intention or obligation to publicly update or revise anyforward-looking statements to reflect any change in our expectations or inevents, conditions, or circumstances on which those expectations may be based,or that may affect the likelihood that actual results will differ from thosecontained in the forward-looking statements. This cautionary statement isapplicable to all forward-looking statements contained in this document.Schedule of Events Sunday, October 12 (all times are ET)
SOURCE Boston Scientific Corporation
