NATICK, Mass., March 25 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the schedule of the Company's major events and news announcements at the Society for Cardiovascular Angiography and Interventions SCAI Annual Scientific Sessions in Partnership with the American College of Cardiology ACC/i2 Summit, which runs from March 29 to April 1 in Chicago.
"Clinical data presented at ACC for the TAXUS® paclitaxel-eluting coronary stent will report on outcomes in a variety of high-risk patient populations," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We expect results will show continued positive data for the TAXUS Stents in these complex patients and lesions."
Schedule of Events (all times are Central Time)
Saturday, March 29
-- ARRIVE Diabetic Analysis. D. Lynn Morris, M.D., will present one-year
outcomes from a pooled analysis of the ARRIVE 1 & 2 Registries,
including subset data for 4,772 patients, including 1,530 diabetics.
The ARRIVE program is designed to collect and analyze "real-world"
safety and clinical outcomes data for the TAXUS® Express2™
paclitaxel-eluting stent system in the treatment of patients with
coronary artery disease. The diabetic sub-group analysis is designed
to evaluate clinical restenosis in diabetic patients and non-diabetics
treated with the TAXUS Express2 Stent. The results will be presented
at 8:00 a.m., during an e-poster session. The Company plans to issue a
press release at this time.
-- ARRIVE High-Risk Patient Analysis. John M. Lasala, M.D., will present
two-year data from 7,307 high-risk patients in the ARRIVE program. The
study is designed to capture long-term safety and effectiveness data of
the TAXUS Express2 Stent in more complex patients treated in routine
practice. The results will be presented at 1:54 p.m., during a
moderated e-poster session. The Company plans to issue a press release
at this time.
Monday, March 31
-- PROMUS™ and TAXUS Stents. Results from the Spirit II Clinical Trial
will be presented by Patrick W. Serruys, M.D., PhD, at 8:00 a.m.,
during a Late Breaking Trial session in Grand Ballroom S100. Dr.
Serruys will provide a two-year data analysis of 300 patients treated
with the XIENCE™ V (PROMUS) Stent or the TAXUS Express Stent.
SPIRIT II is a randomized, non-inferiority trial designed to obtain CE
Mark approval for both the XIENCE V and PROMUS Stents. The PROMUS
Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent
System manufactured by Abbott and distributed by Boston Scientific.
The Company plans to issue a press release at this time.
PROENCY European Registry
In February, Boston Scientific announced the start of its PROENCY
(PROMUS™, ENdeavor® and CYpher®) European registry, which is
the first of its kind to observe different 'olimus'-eluting coronary
stents. The study will collect real-life clinical outcome data for
Boston Scientific's PROMUS Everolimus-Eluting Stent and compare them
with data from Johnson & Johnson's Cypher® Sirolimus-Eluting Stent
and Medtronic's Endeavor® Zotarolimus-Eluting Stent in patients
treated in routine clinical practice. Clinical investigators are
currently being recruited for the U.S. phase of PROENCY, which will
begin upon U.S. launch of the PROMUS Stent expected later this year.
-- Biventricular Pacing Percentage in Heart Failure Patients. Bruce
Koplan, M.D., will present a meta-analysis comparing bi-ventricular
pacing percentages and its impact on the combined risk of death and
heart failure hospitalization. The results will be presented at 9:00
a.m., during an oral abstract session in Room S403.
Tuesday, April 1
-- TAXUS Stent in Large Vessels. David A. Cox, M.D., will present an
analysis of data from the TAXUS IV & V randomized clinical trials
comparing the outcomes of drug-eluting stents versus bare-metal stents
in patients with large vessels. The results will be presented at
8:30 a.m., during an oral abstract session in Room S103d.
-- TAXUS IV/V Diabetic data. Gregg W. Stone, M.D., will present
three-year results from a pooled analysis of the TAXUS IV & V clinical
trials, including angiographic and IVUS outcomes at nine months and
clinical outcomes at three years for 317 diabetic patients and 862
non-diabetic patients. The goal of the study is to determine if
diabetes is a risk factor for restenosis and adverse clinical outcomes
in patients treated with the TAXUS Stent. The results will be
presented at 9:31 a.m., during an oral abstract session in Room S103d.
The Company plans to issue a press release at this time.
-- TAXUS Stent TLR meta-analysis. Stephen G. Ellis, M.D., will present a
meta-analysis of long-term follow-up data from more than 1,300 patients
in the TAXUS clinical trial program with up to five years of follow-up.
The study is designed to determine predictors of target lesion
revascularization (TLR) and long-term outcomes in drug-eluting stent
patients who develop in-stent restenosis. The results will be
presented at 9:43 a.m., during an oral abstract session in Room S103d.
The Company plans to issue a press release at this time.
Other TAXUS Stent Data Presentations
-- The following e-poster presentations will highlight additional safety
and efficacy data from Boston Scientific's comprehensive TAXUS clinical
trial program.
-- "Paclitaxel-Eluting Stents Are Effective in Higher Risk Patients:
Gender and Age Specific Sub-Group Analyses of the TAXUS OLYMPIA
Registry" -- (Dr. Oscar Mendiz, et al., moderated e-poster session,
March 29, 8:00 a.m.)
-- "Drug-Eluting Stents and Acute Myocardial Infarction: Experience from
the TAXUS ARRIVE Registry Program" -- (Dr. John Lasala, et al., e-
poster session, March 29, 8:00 a.m.)
-- "Predictors of Stent Thrombosis and Revascularization in Real-World Use
of the TAXUS Express2 Paclitaxel-Eluting Stent: Insights from the
7,300-Patient ARRIVE Program" -- (Dr. John Lasala, et al., moderated e-
poster session, March 29, 2:00 p.m.)
Boston Scientific will present its latest cardiovascular products at booth #18077 in the Exhibit Hall, including its drug-eluting stent and cardiac rhythm management technologies. The booth will also include product and program displays offering physician and patient resources.
TAXUS, Express, Express2 and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott. The SPIRIT Clinical Program is sponsored by Abbott. The PROMUS/XIENCE V Stents are investigational devices and are limited by federal law to investigational use. Premarket Approval (PMA) applications for these stents are currently under review by the U.S. Food and Drug Administration. The PROMUS/XIENCE V Stents are not for sale in the United States or Japan.
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 clinical trials, scientific activities, product performance, competitive offerings and growth investment. 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.
CONTACT: Paul Donovan
508-650-8541 (office)
508-667-5165 (mobile)
Media Relations
Boston Scientific Corporation
Larry Neumann
508-650-8696 (office)
Investor Relations
Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165
(mobile), Media Relations, or Larry Neumann, +1-508-650-8696 (office),
Investor Relations, both of Boston Scientific Corporation
Web site: http://www.bostonscientific.com/