NATICK, Mass., Oct. 16 /PRNewswire-FirstCall/ -- 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) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 20 to 25 in Washington, D.C.
Boston Scientific will be announcing a wide range of safety and efficacy data on its market-leading TAXUS(R) Express2(TM) and TAXUS(R) Liberte(R) Paclitaxel-Eluting Stent Systems, including final five-year results from the TAXUS IV clinical trial, which studies the TAXUS Express(TM) Stent, and nine- month data on small vessels and long lesions from the ATLAS trial, which studies the TAXUS Liberte Stent. In addition, the Company will present long- term data from the TAXUS V de novo clinical trial and the TAXUS ARRIVE registry.
"The extensive data to be presented at TCT will continue to reinforce the safety, efficacy and deliverability of the TAXUS Stent Systems," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We are pleased to be able to complement our market-leading TAXUS Stents with the addition of our PROMUS(TM) Everolimus Eluting Coronary Stent System in international markets, and the industry's deepest drug-eluting stent (DES) pipeline, which includes our third-generation TAXUS(R) Element(TM) Stent -- currently in clinical trials."
PROMUS is a private-labeled XIENCE(TM) V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation outside the United States. It is currently pending approval by the U.S. Food and Drug Administration and is not commercially available in the United States.
Schedule of Events
Sunday, October 21 (all times are ET)
-- TAXUS ARRIVE data. Two-year follow-up data and sub-group analysis from
the TAXUS ARRIVE registry will be presented by John M. Lasala, M.D.,
PhD, at the DES Summit at 1:19 p.m. in Ballroom C of the Washington
Convention Center. The ARRIVE program is designed to collect and
analyze "real-world" safety and clinical outcomes data from the TAXUS
Express2 Paclitaxel-Eluting Stent System in the treatment of patients
with coronary artery disease. The Company plans to issue a press
release at this time.
Monday, October 22
-- Spirit III Clinical Trial Results -- XIENCE V (PROMUS) Stent and TAXUS
Stent. At 12:15 p.m., one-year data from Abbott's Spirit III Clinical
Trial will be presented by Gregg W. Stone, M.D., at a late-breaking
trial session in the main arena. Dr. Stone will provide an updated
analysis of 1,002 patients treated with the XIENCE V (PROMUS) Stent or
the TAXUS Express Stent. SPIRIT III is a large-scale, randomized,
non-inferiority, U.S. pivotal trial. The Company plans to issue a
press release at this time.
-- TAXUS ATLAS Small Vessels and Long Lesions studies. Nine-month data
from the TAXUS ATLAS global, multi-center studies will be presented at
a late-breaking trial session by the study's co-principal investigator
Mark A. Turco, M.D., at 1:00 p.m. in the main arena. Dr. Turco will
present clinical and angiographic follow-up data on patients treated
with the TAXUS Liberte 2.25 mm stent in small vessels (from the TAXUS
ATLAS Small Vessel study) and the TAXUS Liberte 38 mm stent in long
lesions (from the TAXUS ATLAS Long Lesion study). The Company plans to
issue a press release at this time.
-- TAXUS V de novo results. The Company will release three-year results
from the TAXUS V de novo (DN) clinical trial, evaluating the long-term
safety and clinical efficacy of the TAXUS Express2 Paclitaxel-Eluting
Coronary Stent System versus bare-metal stents in complex patient
populations, including small vessel lesions, long lesions, diabetics
and multiple stents. The TAXUS V DN trial is a prospective,
randomized, double-blind trial that has enrolled 1,172 patients at 66
sites in the U.S. The results will be presented by Stephen G. Ellis,
M.D., at an oral abstract session at 3:45 p.m. in Room 147AB.
-- TAXUS IV five-year results. The Company will release final five-year
data from the TAXUS IV clinical trial, which evaluates the TAXUS
Express2 Paclitaxel-Eluting Coronary Stent System versus bare-metal
stents. This prospective, randomized, double-blind study has enrolled
1,314 patients at 73 U.S. sites. The results will be presented by Dr.
Ellis at 4:00 p.m. at an oral abstract session in Room 147AB. The
Company plans to issue a press release at this time.
Tuesday, October 23
-- CABERNET & BEACH Trial Results on Carotid Stenting. At 4:00 p.m.,
three-year follow-up results from the CABERNET and BEACH clinical
trials will be presented in an oral abstract session by L. Nelson
Hopkins, M.D., in Room 147AB. The CABERNET trial was designed to
evaluate the safety and efficacy of the Company's NexStent(R) Carotid
Stent System and FilterWire EZ(TM) Embolic Protection System, which
received FDA approval in 2006. BEACH is a prospective, single-arm,
multi-center trial designed to evaluate similar clinical outcomes of
the Company's Monorail(R) Carotid WALLSTENT(R) Endoprosthesis in
conjunction with the FilterWire EX(R) and FilterWire EZ(TM) Embolic
Protection Systems in the treatment of high surgical-risk patients with
carotid artery disease. The Company plans to issue a press release at
-- Analyst Meeting. At 5:30 p.m., the Company will host an analyst
meeting in the Grand Ballroom of the Renaissance Hotel. The meeting is
open to the media and will include a DES clinical program update by Dr.
Donald Baim and a DES business update by Paul LaViolette. This meeting
is being webcast and can be accessed in the Investor Relations section
of Boston Scientific's website, http://www.bostonscientific.com. Please visit
the website for details on how to register for the webcast or to access
a replay, which will be archived for 90 days.
-- Symposium on Drug-Eluting Stents. From 8:00 - 10:00 p.m., the Company
will host a symposium entitled "Preclinical to Patients: The DES
Pathway" chaired by Keith D. Dawkins, M.D., in the Grand Ballroom of
the Renaissance Hotel. The symposium will include presentations on
drug development and actions of current DES molecules by Aloke V. Finn,
M.D.; the state of the DES market by Dr. Dawkins; late-breaking data on
next-generation DES by Dr. Turco; and impact of dual anti-platelet
therapy on DES outcomes by Steven R. Steinhubl, M.D. A reception will
be held prior to the symposium at 7:00 p.m.
The Company will also release additional safety and efficacy data from its comprehensive DES clinical trial program, which will be presented at TCT as e- posters. Details can be found on the official TCT program.
Boston Scientific will present its latest innovations and live case broadcasts at booth 3021 in the Exhibition Hall. Key product demonstrations will include drug-eluting stents, carotid artery stenting and peripheral interventions. In addition, Boston Scientific will introduce enhancements to the iLab(R) Ultrasound Imaging System that give physicians the ability to preview device sizing decisions, colorize plaque and blood flow, and overlay color to enrich viewing the IVUS image.
TAXUS Liberte is an investigational device and not available for sale in the United States. TAXUS Element is currently in clinical trials and is not available for sale. The Carotid WALLSTENT is an investigational device in the United States and is limited by U.S. law to investigational use. The safety and effectiveness of the FilterWire EZ Embolic Protection System for use in carotid arteries has not been established in the U.S. and is currently investigational. XIENCE is a trademark of the Abbott Laboratories group of companies.
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: http://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 our financial performance, our growth strategy, our product performance, our clinical trial strategy, our operational strategy, 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.
CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
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