NATICK, Mass., Sept. 14 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, September 21 - 25 in Washington, D.C.
"We look forward to the presentation of data from the PLATINUM QCA trial and the PERSEUS clinical program, which support the performance of our two platinum chromium drug-eluting stent platforms -- PROMUS® Element™ and TAXUS® Element™(1)," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific's Cardiology, Rhythm and Vascular Group. "Our PROMUS Element Everolimus-Eluting Stent System and TAXUS Element Paclitaxel-Eluting Stent System continue to be well received by European physicians, and we are looking forward to U.S. approval. We also anticipate positive data from the TAXUS ATLAS trials, assessing the long-term performance of our TAXUS Liberte® Stents in patients with workhorse and complex lesions."
Schedule of Events (All times are ET; all events are held at the Walter E. Washington Convention Center.)
Tuesday, September 21
- PROMUS Element Stent Clinical and Angiographic Outcomes. Ian T. Meredith, M.D., Co-Principal Investigator of the PLATINUM clinical program, will present 30-day clinical outcomes and nine-month qualitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data from the PLATINUM QCA study in a podium session at 4:19 p.m. during the Drug-Eluting Stent Summit in Ballroom C. The PLATINUM clinical program includes five separate multi-center studies designed to assess the safety and efficacy of the PROMUS Element Stent. The Company plans to issue a press release at this time.
- SYNTAX Study Data. Patrick W. Serruys, M.D., Ph.D., and Friedrich W. Mohr, M.D., Ph.D., will present analyses of three-year follow-up data from the landmark SYNTAX clinical trial assessing optimal revascularization strategies in patients with left main disease and three-vessel disease. Both analyses will be presented in a featured clinical research session from 6:00 – 8:00 p.m. in Room 208AB. SYNTAX is the first randomized, controlled clinical trial comparing percutaneous coronary intervention using drug-eluting stents to coronary artery bypass graft surgery in patients with left main and/or three-vessel disease.
Wednesday, September 22
- TAXUS Element (ION) Stent Diabetic Study. Louis A. Cannon, M.D., Co-Principal Investigator of the PERSEUS clinical program, will present 12-month data from the PERSEUS Diabetic study in a poster session from 1:00 – 3:30 p.m. on the Lower Level. Results will assess the benefit of the TAXUS Element Stent in patients with and without diabetes. The Company plans to issue a press release at this time.
- TAXUS ATLAS studies. Mark A. Turco, M.D., Co-Principal Investigator of the TAXUS ATLAS trials, will present five-year data from the TAXUS ATLAS Workhorse trial and four-year data from the TAXUS ATLAS Long Lesion trial, and John A. Ormiston, M.D., will present four-year data from the TAXUS ATLAS Small Vessel trial in a series of poster sessions from 1:00 – 3:30 p.m. on the Lower Level. Results will assess the long-term benefit of the TAXUS Liberte Stent in workhorse lesions, the TAXUS Liberte Long 38 mm Stent in long lesions and the TAXUS Liberte Atom™ 2.25 mm Stent in small vessels. The Company plans to issue a press release at this time.
- Boston Scientific Symposium on Innovation. The Company will sponsor a symposium titled "Pushing the Boundaries of Technology & Innovation," chaired by Dr. Dawkins in the Grand Ballroom of the Renaissance Hotel from 8:00 – 9:30 p.m. The symposium will feature presentations by Martin B. Leon, M.D., of the Cardiovascular Research Foundation titled "Making More Possible for More Patients Through Innovations," and by Mr. Steve Wozniak, Co-Founder of Apple Computer, titled "Defining Tomorrow's Innovation." A reception will be held prior to the symposium, beginning at 7:00 p.m.
Thursday, September 23
- PROMUS and TAXUS Express Stents. Gregg W. Stone, M.D., will present two-year results from the SPIRIT IV Clinical Trial at 11:24 a.m., during a Late-Breaking Trials session in the Main Arena. SPIRIT IV is a prospective, single-blinded, multi-center clinical trial with 3,690 patients randomized 2:1 to the XIENCE V® (PROMUS) Stent or the TAXUS Express® Stent. The TAXUS Express Stent is a first-generation drug-eluting stent that has been replaced by the thin-strut TAXUS Liberte Stent and more recently by the platinum chromium TAXUS Element Stent.
Saturday, September 25
- HORIZONS-AMI Three-Year Data. Dr. Stone will present three-year data from the HORIZONS-AMI clinical trial at 11:24 a.m., during a Late-Breaking Trials session in the Main Arena. HORIZONS-AMI is a randomized, controlled clinical trial designed to compare TAXUS stents to bare-metal stents in 3,400 AMI (acute myocardial infarction) patients. The Company plans to issue a press release at this time.
Boston Scientific will present its latest cardiology, rhythm and vascular products at booth #1443 in the Exhibit Hall.
TAXUS, Express, Express2, Liberte, Atom, PROMUS, Element and ION are trademarks of Boston Scientific Corporation or its affiliates. XIENCE V is a trademark of the 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 Company has received CE Mark approval for both the PROMUS Element and the TAXUS Element Stent Systems and has launched the products in Europe and other international markets. In the United States, the PROMUS Element and TAXUS Element (ION) Stent Systems are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
The safety and effectiveness of the TAXUS Stents has not been established in patients with an acute myocardial infarction, or in patients with left main or three-vessel disease.
About Boston Scientific
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 27A of the Securities Act of 1933 and 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, regulatory approvals, new product launches, 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 hereafter. 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.
(1) The TAXUS Element Stent System will be commercialized as the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in the U.S.
Boston Scientific Corporation
Boston Scientific Corporation
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