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2025'02.03.Mon
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2007'10.03.Wed
Boston Scientific Receives CE Mark Approval for New Apex(TM) PTCA Dilatation Catheters
October 01, 2007


- New Design Offers Greater Flexibility in the Management
of Patients With Complex Atherosclerosis


    PARIS, Oct. 1 /Xinhua-PRNewswire/ -- Boston Scientific
Corporation (NYSE: BSX) announced today that the Apex(TM)
Monorail and Over-The-Wire (OTW) PTCA dilatation catheters
have received CE Mark approval. Both Monorail and OTW
catheters are available in two designs to provide European
physicians with further options for managing patients with
complex atherosclerosis (blockage of the arteries).

    Apex is a high-performance balloon catheter that allows
physicians to reach and cross the most challenging
atherosclerotic lesions. Designed for use with drug-eluting
stents, Apex has been developed specifically to address
physicians' need for a catheter that can reach not only the
furthest blockages but also cross particularly tight or
complex lesions. Dr. Marie-Claude Morice, head of the
Institut Cardiovasculaire Paris Sud, France, was the first
clinician to use catheters from the new Apex product line.
"Apex PTCA dilatation catheters performed well during
intervention procedures," she said. "The
catheters are easy to guide through vessels and can cross
lesions efficiently. I welcome innovative designs like
Apex, which should benefit patients by minimising trauma
and helping to reduce procedure time."

    Apex represents a totally new strategy in balloon
catheters, giving today's physicians the technology they
need to treat complex lesions. Both Apex Monorail and OTW
catheters are available in two different 1.5 mm designs,
"Apex 1.5 mm Push" and "Apex 1.5 mm
Flex". Apex Push offers optimal pushability for tight
lesions, while Apex Flex provides excellent performance for
the most tortuous arteries. The dual Apex 1.5 mm balloon
catheter designs enable physicians to select the
appropriate catheter based on the clinical situation.

    "Achieving CE Mark approval is an important step
for Apex," said Jeff Goodman, President of Boston
Scientific International. "As a leader in the field of
cardiovascular device technology, Boston Scientific listened
and responded to physicians' requests for improvements to
existing catheters. We are delighted to offer this highly
innovative device that addresses physicians' needs for
treating the most difficult and tortuous coronary
lesions."

    PTCA dilatation catheters are used to open up arteries
blocked by atherosclerosis, which if left untreated can
cause heart attacks and strokes by stopping blood from
reaching the heart muscle and brain. Coronary heart disease
by itself is the single most common cause of death in
Europe, accounting for 1.95 million deaths in Europe each
year.(1)

    Apex is the latest technological development by Boston
Scientific to improve the management of patients with
coronary atherosclerosis undergoing percutaneous coronary
intervention (PCI). Boston Scientific enables PCI
optimisation through a broad range of devices, including
ultrasound imaging to assess lesions and balloon catheters
and drug-eluting stents to reopen blocked arteries. This
broad portfolio of devices enables physicians to achieve
safe and effective outcomes for their patients.

    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.

    Cautionary Statement Regarding Forward Looking
Statements

    This press release contains forward-looking statements
within the meaning of Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements may be
identified by words like "anticipate,"
"expect," "project,"
"believe," "plan,"
"estimate," "intend" and similar words.
These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us
at the time and are not intended to be guarantees of future
events or performance. These forward-looking statements
include, among other things, product performance,
competitive offerings, and our market position. If our
underlying assumptions turn out to be incorrect, or if
certain risks or uncertainties materialize, actual results
could vary materially from the expectations and projections
expressed or implied by our forward-looking statements.
These factors, in some cases, have affected and in the
future (together with other factors) could affect our
ability to implement our business strategy and may cause
actual results to differ materially from those contemplated
by the statements expressed in this press release. As a
result, readers are cautioned not to place undue reliance
on any of our forward-looking statements.

    Factors that may cause such differences include, among
other things: future economic, competitive, reimbursement
and regulatory conditions; new product introductions;
demographic trends; intellectual property; litigation;
financial market conditions; and, future business decisions
made by us and our competitors. All of these factors are
difficult or impossible to predict accurately and many of
them are beyond our control. For a further list and
description of these and other important risks and
uncertainties that may affect our future operations, see
Part I, Item IA- Risk Factors in our most recent Annual
Report on Form 10-K filed with the Securities and Exchange
Commission, which we may update in Part II, Item 1A - Risk
Factors in Quarterly Reports on Form 10-Q we have filed or
will file thereafter. We disclaim any intention or
obligation to publicly update or revise any forward-looking
statements to reflect any change in our expectations or in
events, conditions, or circumstances on which those
expectations may be based, or that may affect the
likelihood that actual results will differ from those
contained in the forward-looking statements. This
cautionary statement is applicable to all forward-looking
statements contained in this document.

    Notes for Editors

    Arteries become blocked as a result of a process called
atherosclerosis (`hardening of the arteries'), in which the
arteries become blocked by a build-up of fatty deposits
(termed `plaque'). Plaque is made up of fat, cholesterol,
calcium and other substances found in the blood. As it
grows, the build-up of plaque narrows the inside of the
artery and, in time, may restrict blood flow to the heart
or the brain leading to heart attack or stroke.

    Blocked arteries can be opened by insertion of a
catheter (which is a thin flexible tube) into the artery
(the catheter is actually inserted into the patient's
femoral artery in the groin and guided along the arterial
system to the site of the blockage) and inflation of a tiny
balloon at the tip of the catheter to stretch the artery.
When the catheter is removed a tiny rigid tube, or stent,
is left in the artery to keep it open. Rates of stent
placement vary widely but approximately 500 stents are
inserted per million population in Europe.(2)

    The CE Mark (Conformite Europeenne, or European
conformity) is a visible declaration by a manufacturer that
the equipment complies with all applicable European Union
directives on health and safety. This mandatory mark allows
manufacturers and exporters to circulate products freely
within European Union member countries.

    REFERENCE

    (1) British Heart Foundation Heartstats.
    http://www.heartstats.org/datapage.asp?id=754 (last
accessed 19 April 2007).

    (2) British Heart Foundation Heartstats.
   
http://www.heartstats.org/temp/ESspTabsp3.2spweb05hs1hs.xls
(last accessed 19 April 2007).


    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
PR
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