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2025'03.15.Sat
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2007'02.04.Sun
Study of Boston Scientific's Carotid WALLSTENT(TM) Monorail(TM) Design Shows Superior Safety Results in Stroke Prevention
June 21, 2006

    PARIS, June 21 /Xinhua-PRNewswire/ -- Boston Scientific
Corporation (NYSE: BSX) today welcomed the results of a new
study, led by Dr. Marc Bosiers of Belgium, demonstrating
that the closed cell design of Boston Scientific's Carotid
WALLSTENT(TM) Monorail(TM) provides superior clinical
outcomes compared to open cell carotid stents.(1) Closed
cell stents provide greater plaque coverage of the carotid
artery, thereby potentially reducing the risk of a delayed
embolism relative to open cell stents. The study was
presented at the 60th Annual Meeting of the Society for
Vascular Surgery on June 1st by Dr. Joseph Hart, University
of Rochester School of Medicine and Dentistry, Rochester,
New York, who helped collect the data during his Marco Polo
fellowship in Dendermonde, Belgium.

    The study compares the clinical results of open versus
closed cell carotid stents in 709 patients. At 30-days post
procedure, symptomatic patients that received the closed
cell stent showed a 4.1 times reduction of stroke,
transient ischemic attacks (TIA, a major predictor of
stroke) or death -- compared to the open cell stent group.
The Carotid WALLSTENT(TM) Monorail(TM) represented more
than 70 percent of the closed cell stents used in this
study. Closed cell stents, such as Boston Scientific's
Carotid WALLSTENT(TM) Monorail(TM), have overlapping or
fully connecting struts and cover 5 to 10 times more of the
vascular wall as compared to open cell stents that have both
connecting and non-connecting struts.(2)

    Dr. Marc Bosiers, AZ Sint Blasius in Dendermonde,
Belgium, Principle Investigator of the study, commented to
the Society for Vascular Surgery, "There were less
adverse events within 30 days with the closed cell stent.
The closed cell stent design offers a greater potential to
scaffold and support fractured plaque and keep material
that could embolize to the brain, or cause small clots,
from traveling through the vasculature. Closed cell stents
cover a greater percent of the vascular wall in the stented
region and have less uncovered cell area. Therefore we would
recommend them for symptomatic patients."

    Dr. Bosiers also commented that, "Patients are
most at risk for stroke during the 30 days after a carotid
stenting procedure. The Carotid WALLSTENT(TM) Monorail(TM)
demonstrated fewer complications at 30-days compared to
open cell stents, likely due to its closed cell design,
which offers greater scaffolding and assists in preventing
plaque dislodgement."

    The study also reported lower rates of major adverse
events within 30 days post-procedure in the patient
population treated with eccentric filters (non-central axis
design), such as Boston Scientific's FilterWire EZ(TM)
Embolic Protection System, compared to the population
treated with concentric (center axis design) embolic
protection devices. Filters are used during the carotid
artery stenting procedure to protect the patient's brain
from damage caused by plaque debris or small blood clots.

    In the study, the overall combined 30-day rate of
stroke, TIA, or death for open and closed cell design
stents was 3.7 percent. The overall rates of stroke or
death at 30-days, one year and three years were 1.4
percent, 6.0 percent and 15.1 percent, and restenosis rates
were 0.2 percent, 0.9 percent and 5.6 percent, respectively.
There was no difference in rates of restenosis (re-narrowing
of a previously opened vessel) between symptomatic and
asymptomatic patients.

    "These results should give physicians great
confidence when treating their patients with the Carotid
WALLSTENT(TM) Monorail(TM) and FilterWire EZ(TM) Embolic
Protection System," said Jeff Goodman, President
Boston Scientific International. "The excellent
results from this trial build on the existing clinical
evidence for using these devices to treat patients with
carotid artery disease and explain why the Carotid
WALLSTENT(TM) Monorail(TM) and FilterWire EZ(TM) maintain
the number one market share position outside the United
States."

    Carotid arteries, located on either side of the neck,
are the main conduit for blood flow to the brain. When
narrowing occurs, patients are at risk for stroke -- the
third leading cause of death, and the leading cause of
disability worldwide.(3) Carotid artery stenting is a
minimally-invasive procedure in which a stent is delivered
to the site of the blockage and expanded to open the
carotid artery and restore blood flow.

    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 .

    REFERENCES:

    1)  Bosiers, Peeters, Hart et al. Do Device
Characteristics
        Impact Outcome In Carotid Artery Stenting?
Presented at the 2006
        Vascular Annual Meeting, Philadelphia.
    2)  Boston Scientific bench tests.
    3)  http://www.who.int/cardiovascular_diseases/en/
        cvd_atlas_16_death_from_stroke.pdf

    For more information, please contact:

     Geraldine Varoqui,
     Boston Scientific PR Manager International
     Tel:    +49-2102-489-461
     Mobile: +49-170-782-85-58
     Email:  varoquig@bsci.com

     Maren Koban,
     BSC press office
     Tel:    +44-0-20-7973-4497
     Mobile: +44-0-771-3631-514
     Email:  mkoban@hillandknowlton.com

SOURCE  Boston Scientific International
PR
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