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Boston Scientific Receives CE Mark Approval for New Apex(TM) PTCA Dilatation Catheters

Paris (ots/PRNewswire)

- New Design Offers Greater Flexibility in the Management of
Patients  With Complex Atherosclerosis
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 (Conformité Européenne, 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).

Contact:

Contact: Géraldine Varoqui, Boston Scientific PR Manager
International, Tel: +49-2102-489-461, varoquig@bsci.com Or Tracy
Paul, BSC press office, Tel: +44-20-7413-3101,
tpaul@medicalknowledgegroup.com

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