Boston Scientific Corporation (NYSE: BSX) today announced preliminary
six-month results from Phase I of its global OLYMPIA registry, supporting
the safety and efficacy of the TAXUS(R) Liberte(TM) coronary stent
system(1) in real-world patients. The results were announced at the SOLACI
(Sociedad Latino Americana de Cardiologia Intervencionista) Congress in
Porto Alegre, Brazil.
Phase I of the global OLYMPIA registry included 529 patients from seven
countries(2) in which TAXUS Liberte has already been approved. The Phase I
enrollment comprised diverse and high-risk populations, including patients
with complex lesions or clinical characteristics (57.0 percent),
multi-vessel disease (49.1 percent), prior myocardial infarction (45.9
percent) and diabetes (49.9 percent).
"The OLYMPIA Phase I six-month data are very impressive and show
consistency with results from other TAXUS clinical trials and registries,"
said Waqar H. Ahmed, M.D., M.S., FACC, at King Fahed Armed Forces Hospital
in Jeddah, Saudi Arabia, and the Principal Investigator for the first Phase
of the OLYMPIA registry. "The data further support the strong performance
of the TAXUS Liberte coronary stent system in challenging lesions and
high-risk patients."
"The initial results from OLYMPIA build on the unparalleled rigor of
the TAXUS clinical program and provide us with positive, consistent
clinical outcomes data among patients with complex lesions or
characteristics," said Jeff Goodman, President of Boston Scientific
International. "As the second-generation platform for our TAXUS stent
system, the Liberte stent is designed to improve deliverability and
conformability to challenging lesions and demonstrates Boston Scientific's
commitment to providing new and innovative treatment options."
OLYMPIA Phase I six-month findings demonstrated an overall
TAXUS-related major cardiac event rate of 2.3 percent, including cardiac
death (0.8 percent), myocardial infarction (1.3 percent), and TAXUS-related
re-intervention of the target vessel (1.3 percent). The OLYMPIA Phase I
registry reported a low stent thrombosis rate of 1.5 percent, which is
consistent with safety data from other DES registries.
The multi-phased OLYMPIA registry plans to enroll up to 35,000 patients
from more than 600 centers in 70 countries and is designed to analyze
real-world clinical outcomes data for Boston Scientific's next-generation
TAXUS Liberte paclitaxel-eluting stent system in the treatment of patients
with coronary artery disease.
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:
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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.
Boston Scientific Corporation
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