TAXUS II Clinical Trial Follow-Up Data Demonstrates Excellent Long-Term Outcomes at Four Years

TAXUS II Clinical Trial Follow-Up Data Demonstrates Excellent Long-Term Outcomes at Four Years

September 06, 2006

Overall Cardiac Death Rate for Combined Bare-Metal Control Group Equivalent to TAXUS Slow- and Moderate-Release Formulations

    NATICK, Mass. and BARCELONA, Spain, Sept. 6
/Xinhua-PRNewswire/ -- Boston Scientific Corporation (NYSE:
BSX) today announced four-year follow-up data from its TAXUS
II paclitaxel-eluting stent system clinical trial. The data
demonstrated that the safety and efficacy advantages
associated with the TAXUS(TM) stent system were maintained
at four years. The Company made the announcement at the
annual European Society of Cardiology/World Congress of
Cardiology 2006 in Barcelona, Spain.

    "The long-term results from the TAXUS II study
speak to the remarkable effectiveness of paclitaxel-eluting
technology in the treatment of coronary artery
disease," said Professor Antonio Colombo, M.D.,
Columbus Hospital and San Raffaele Hospital in Milan, the
trial's Principal Investigator. "The TAXUS II study
data itself is outstanding with low target lesion
revascularization (TLR) rates, low cardiac death rates, and
no new stent thrombosis from three to four years. This
technology has truly changed the way physicians treat
coronary artery disease."

    "We are extremely pleased with the TAXUS II
results, which represent an important milestone in the
evolving story of paclitaxel-eluting stent
technology," said Jeff Goodman, President Boston
Scientific International. "TAXUS II is the first
large-scale TAXUS clinical trial undertaken by Boston
Scientific and continues to break new ground at four years.
Backed by excellent long-term safety and efficacy results
from TAXUS II and other TAXUS clinical trials, the TAXUS
stent system continues to maintain its leadership position
in the markets we serve while offering physicians and their
patients a best-in-class treatment for coronary artery
disease."
    
    Excellent efficacy results

    The long-term TAXUS II results suggest that the TAXUS
stent system stably decreases restenosis rates as
demonstrated by significant reductions in TLR. TAXUS II
results reported a low overall TLR rate of 7.2 percent in
the slow-release formulation and 3.7 percent in the
moderate-release formulation, as compared to 15.7 percent
in the control group (P=0.0004), resulting in an absolute
reduction of 54 percent versus control for the slow-release
formulation and a 76 percent absolute reduction versus
control for the moderate-release formulation. The Company
has commercialized the slow-release formulation; the TAXUS
stent in a moderate-release formulation is not available
for commercial distribution.

    Outstanding long-term safety results

    TAXUS II, the first TAXUS clinical trial to evaluate
late clinical safety and efficacy outcomes of both the
slow- and moderate-release formulations, reported no stent
thrombosis from three to four years. The study also
reported a low overall cardiac death rate of 1.6 percent
for both the slow- and moderate-release formulations up to
four years, which showed no statistical difference when
compared to the combined bare-metal control overall cardiac
death rate of 1.5 percent. The overall myocardial infarction
rate was 
4.7 percent in the slow-release formulation and 5.3 percent
in the moderate release formulation, as compared to 6.7
percent in the combined control.

    The TAXUS II trial is a 536-patient, 15-country,
randomized, double-blind, controlled study of the safety
and efficacy of a TAXUS paclitaxel-eluting coronary stent,
in which two sequential cohorts of patients with standard
risk, de novo coronary artery lesions were treated with
different dose formulations.

    Clinical follow-up at four years in TAXUS II included
96.3 percent of the patients initially enrolled (516/536).

    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.
The Company 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 the
commercialization of new technologies, competitive
offerings, intellectual property and other factors
described in the Company's filings with the Securities and
Exchange Commission.

    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