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2025'03.16.Sun
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2007'02.11.Sun
Independent Meta-Analysis Confirms Safety and Efficacy of TAXUS(TM) Stent
October 25, 2006

-- Results also Show Statistically Significant Late Stent Thrombosis Rate for Cypher(TM) Stent vs. Bare-Metal Stent
    NATICK, Mass., and WASHINGTON, Oct. 25
/Xinhua-PRNewswire/ -- Boston Scientific Corporation (NYSE:
BSX) today announced that an independent meta-analysis of
more than 3,500 patients from five clinical trials,
conducted by the Cardiovascular Research Foundation,
confirmed the Company's own analysis that the TAXUS(TM)
paclitaxel-eluting coronary stent is safe and effective.
The new analysis was presented by Gregg W. Stone, M.D.,
Vice Chairman of the Cardiovascular Research Foundation and
Professor of Medicine, Columbia University Medical Center in
New York, at a symposium hosted by Boston Scientific in
conjunction with the eighteenth annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium in
Washington, D.C.

    The patient-level meta-analysis reported data on the
TAXUS stent from the TAXUS I, II, IV, V and VI trials that
studied 3,506 patients. A parallel patient-level
meta-analysis was also performed on the Cypher(TM) stent
from the RAVEL, SIRIUS, E-SIRIUS AND C-SIRIUS trials that
studied 1,748 patients, and will be presented in full by
Dr. Stone today.

    The results presented today showed similar rates of
freedom from stent thrombosis and similar rates of stent
thrombosis beyond one year for both the TAXUS and Cypher
stents.

    For the TAXUS stent, the rate of freedom from stent
thrombosis at up to four years was 98.7 per cent (1.3 per
cent thrombosis rate), compared to a 99.1 per cent rate of
freedom from stent thrombosis (0.9 per cent stent
thrombosis rate) in the bare-metal stent (BMS) control
group. This meta-analysis showed a small but statistically
significant (0.40 per cent, p = 0.033) increase in the
incidence of stent thrombosis after one year for the TAXUS
stent as compared to the BMS control. However, there was no
corresponding increase in death or myocardial infarction
(MI).

    Dr. Stone also presented data that showed for the
Cypher stent, the rate of freedom from stent thrombosis
over four years was 98.8 per cent (1.2 per cent stent
thrombosis rate), compared to a rate of 99.4 per cent (0.6
per cent stent thrombosis rate) in the BMS control group.
This meta-analysis also showed a small but statistically
significant (0.57 per cent, p = 0.025) increase in the
incidence of stent thrombosis after one year for the Cypher
stent as compared to the BMS control. This is the first time
a statistically significant increase in late stent
thrombosis has been reported for the Cypher stent.

    The results for up to four years follow-up also showed
a trend toward a lower rate of all-cause death, as well as
the combination all-cause death or Q-wave MI, for the TAXUS
stent compared to its BMS control. Despite the 0.4 per cent
increase in late-stent thrombosis, the all-cause death rate
at up to four years was 6.4 per cent for the TAXUS stent
compared to 7.0 per cent for bare-metal (a statistically
non-significant decrease). Similarly, the all-cause death
or Q-wave MI rate showed a trend toward better outcomes for
the TAXUS stent at 7.6 per cent compared to 8.1 per cent for
BMS (a statistically non-significant decrease).

    "It is now fully apparent that the small increase
in late stent thrombosis that we previously reported is
actually found in both drug-eluting stents," said Dr.
Donald S. Baim, the Chief Medical and Scientific Officer
for Boston Scientific. "Importantly, the TAXUS
paclitaxel-eluting stent continues at four-year follow-up
to show the same or lower risk of death or MI as BMS, and a
50 per cent lower need for repeat procedures. In net, it
clearly remains a safe and effective therapy."

    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 .

    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, integration of acquired companies, Boston
Scientific's overall business strategy, and other factors
described in Boston Scientific's filings with the
Securities and Exchange Commission.

    For more information, please contact:

     Geraldine Varoqui
     Boston Scientific, PR Manager International
     Tel:   +49-2102-489-461
     Email: varoquig@bsci.com

     Tracy Paul
     BSC press office
     Tel:   +44-20-7413-3101
     Email: tpaul@medicalknowledgegroup.com

SOURCE  Boston Scientific Corporation
PR
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