NATICK, Mass., Aug. 31 /PRNewswire-AsiaNet/ –
Results Expected to Continue to Support Safety and Performance of Boston
Scientific’s Second-Generation Drug-Eluting Stent System
Boston Scientific Corporation (NYSE: BSX) announced today that enrollment
has exceeded 13,000 patients in the TAXUS OLYMPIA registry, designed to confirm
the safety and performance of the Company’s second-generation drug-eluting
coronary stent (DES), TAXUS(R) Liberte(TM)[1], in a real-world setting. OLYMPIA
is the world’s largest DES registry to date and plans to enroll up to 27,000
patients treated for complex coronary lesions, at more than 500 centers
worldwide.
"The advent of the TAXUS Liberte stent system has raised the bar in terms
of the performance of DES since it provides physicians with the increased
flexibility and deliverability they need to treat complex coronary artery
blockages," said Martyn Thomas, M.D., F.E.S.C., Director of Invasive
Cardiology, Kings College Hospital, London, UK and one of the coordinating
investigators of the registry. "We look forward to seeing how these improved
features will be reflected in the near- and long-term clinical outcomes to be
obtained from the OLYMPIA registry."
The multi-center, prospective, observational OLYMPIA registry will evaluate
a variety of safety and performance measures, including the rate of repeat
procedures (target lesion revascularization, or TLR), major adverse cardiac
events such as heart attack (myocardial infarction) and death, and in-stent
thrombosis. Additionally, sub-analyses on complex patient groups such as
diabetics, patients with multi-vessel disease, in-stent re-blockages
(restenosis) or a prior history of heart attack will be performed.
"The OLYMPIA registry is the first to specifically document the real-world
outcomes in patients treated with a next-generation DES such as Boston
Scientific’s TAXUS Liberte stent," said Jeff Goodman, President, Boston
Scientific International. "OLYMPIA will provide some of the most comprehensive
real-world data for DES use in treating coronary artery disease. We expect the
results will further support the safety and performance of the TAXUS Liberte
stent system in complex lesions and complex patients."
The OLYMPIA registry is enrolling patients in multiple phases,
corresponding to the commercial introduction of the TAXUS Liberte stent system
in different regions of the world. The initial, transitional phase enrolled 529
patients from a limited number of international markets in which TAXUS Liberte
stent is already commercially available. The six-month results from Phase I
were presented at the SOLACI 2006 Congress in Porto Alegre, Brazil and showed a
low overall TAXUS-related major cardiac event rate of 2.3 percent. Additional
data will be presented at the European Society of Cardiology/World Congress of
Cardiology 2006 in Barcelona, Spain.
"Phase I showed that 50 percent of the patients included were diabetic,"
stated Waqar H. Ahmed, M.D., M.S., FACC, at King Fahed Armed Forces Hospital in
Jeddah, Saudi Arabia, coordinating investigator of Phase I and also co-chairing
Phase II with Oscar A. Mendiz, M.D., at Fundacion Favaloro in Buenos Aires,
Argentina. "We are excited to have the TAXUS Liberte stent system available to
treat our patients," said Dr. Ahmed. "It is a significant advance in stent
design and deliverability and may be more effective than other drug eluting
stents in patients with more complex lesions."
Phases II and III, for which enrollment is currently ongoing, involves up
to 24,000 patients from Intercontinental and European markets. The final phase
will enroll U.S. patients. Data collected for the OLYMPIA registry are being
uniformly reported through a web-based data capture system, and all major
clinical events are regularly reviewed and adjudicated by an independent
Clinical Event Committee of interventional cardiologists or an Independent
Medical Reviewer.
About the TAXUS Liberte Stent
The TAXUS Liberte coronary stent system is the second generation to Boston
Scientific’s market-leading paclitaxel-eluting coronary stent system, TAXUS(R)
Express2(TM). The Liberte(TM) stent features the Veriflex(TM) stent design, a
highly flexible cell geometry with thin struts and uniform cell distribution.
This new platform has been designed for uniform drug delivery and to offer
improved deliverability and conformability in challenging anatomy.[2] TAXUS
Liberte is pending PMA approval and is not available for sale in the U.S.
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 or
http://www.publicaster.com/info/bostonscientific/esc2006
This press release contains forward-looking statements. Boston Scientific
wishes to caution the reader of this press release that actual results may
differ from those discussed in the forward-looking statements and may be
adversely affected by, among other things, risks associated with new product
development and commercialization, clinical trials, intellectual property,
regulatory approvals, competitive offerings, Boston Scientific’s overall
business strategy, and other factors described in Boston Scientific’s filings
with the Securities and Exchange Commission.
[1] The TAXUS Liberte Stent system is currently only available
for sale in Europe, Asia Pacific, and Latin America.
[2] Based on internal bench testing (n=3). Data on file.
SOURCE: Boston Scientific Corporation
CONTACT: Geraldine Varoqui of Boston Scientific,
PR Manager International,
+49-2102-489-461,
varoquig@bsci.com or
Tracy Paul,
BSC press office,
+44-20-7413-3101,
tpaul@medicalknowledgegroup.com
Web site: http://www.bostonscientific.com
http://www.publicaster.com/info/bostonscientific/esc2006
(BSX)
September 1, 2006
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