OLYMPIA Phase I Registry Confirms Safety and Performance of TAXUS(TM) Liberte(TM) Stent System in Complex Patients and Lesions

OLYMPIA Phase I Registry Confirms Safety and Performance of TAXUS(TM) Liberte(TM) Stent System in Complex Patients and Lesions

September 06, 2006

Initial Six-Month Results Show Positive Outcomes in Diabetic Patients; Safety Events for Diabetic Subset Lower Than Overall Patient Population

    NATICK, Mass. and BARCELONA, Spain, Sept. 6
/Xinhua-PRNewswire/ -- Boston Scientific Corporation (NYSE:
BSX) today announced six-month results from Phase I of its
global TAXUS OLYMPIA registry, supporting the safety and
performance of the TAXUS(TM) Liberte(TM) coronary stent
system in real-world patients. The results were announced
at the European Society of Cardiology/World Congress of
Cardiology 2006 in Barcelona, Spain. TAXUS Liberte is
currently pending approval by the US Food and Drug
Administration and is not for sale in the United States.

    Phase I of the global OLYMPIA registry included 529
patients from seven countries in which TAXUS Liberte(1) has
been approved. The Phase I enrolment consisted of diverse
and high-risk populations, reflecting complex usage
patterns in "real world" clinical practices. A
majority of patients exhibited complex lesions or clinical
characteristics, including, multi-vessel disease (49.1 per
cent), prior myocardial infarction (45.9 per cent), left
anterior descending lesions (54.0 per cent), small vessels
(9.0 per cent), long lesions (18.9 per cent) and diabetes
(49.9 per cent). 

    "The OLYMPIA Phase I six-month data are very
impressive, especially considering the high degree of
patient and procedural complexity across a broad range of
real world cases," 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 show consistency
with results from other TAXUS clinical trials and
registries, further supporting the strong performance of
the TAXUS Liberte coronary stent system." 

    OLYMPIA Phase I six-month findings demonstrated an
overall TAXUS Liberte related cardiac event rate of 2.3 per
cent, including cardiac death (0.8 per cent), myocardial
infarction (1.3 per cent), and TAXUS Liberte related
re-intervention of the target vessel (1.3 per cent). The
OLYMPIA Phase I registry reported a stent thrombosis rate
of 1.5 per cent, including 1.1 per cent at 0-30 days and
0.4 per cent from 30-180 days. This low rate of thrombosis
is consistent with safety data from other drug-eluting sent
registries. Non-compliance with antiplatelet therapy was
found to be the strongest risk factor for thrombosis and
was observed for half of the total stent thrombosis cases
in the Olympia Phase I registry. 

    In the diabetic subset (261 patients), OLYMPIA reported
low rates of overall TAXUS Liberte related cardiac events
(1.5 per cent), cardiac death (0.4 per cent), myocardial
infarction (0.8 per cent), TAXUS Liberte related
re-interventions (1.1 per cent) and stent thrombosis (1.1
per cent). Each of these outcomes for the high-risk
diabetic patient group was lower than the rates for the
overall population. 

    "Phase I of OLYMPIA shows excellent outcomes with
TAXUS Liberte in patient subsets considered high risk for
bare metal stenting, including diabetics, small vessels,
long lesions and multiple stents," said Jeff Goodman,
President of Boston Scientific International. "The
results build on the impressive body of positive data from
the TAXUS clinical program, especially in complex diabetic
patients. Our second-generation platform - TAXUS Liberte -
offers exceptional deliverability backed by the confidence
of proven outcomes in complex lesions." 

    Phase I of the OLYMPIA registry met its primary
endpoint of TAXUS Liberte stent-related cardiac events at
30 days post implant. In addition, all secondary endpoints
were met including; stent-related cardiac events at six
months, target vessel-related cardiac events at 30 days and
six months, and angiographic and technical success. 

    The global, prospective OLYMPIA registry plans to enrol
up to 27,000 patients in multiple phases from more than 500
centres in 70 countries and is designed to analyse
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:
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 commercialisation, 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) TAXUS Liberte stent is not approved for use in the
European Economic Area in vessel diameter < 2.25 mm 

    For more information, please contact:

     Geraldine Varoqui, 
     Boston Scientific PR Manager International
     Tel:   [phone]
     Email: [e-mail]

     Tracy Paul, 
     BSC press office
     Tel:   [phone]
     Email: [e-mail] 

SOURCE  Boston Scientific Corporation