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Boston Scientific Announces European Approval Of New Heart Failure Lead
Boston Scientific
Corporation (NYSE: BSX) announced CE Mark approval of its ACUITY(R)
Spiral left ventricular lead for use with cardiac resynchronization therapy
defibrillators and cardiac resynchronization therapy pacemakers, both of
which treat heart failure. The product features a spiral design and small
lead tip profile (4 French) for placement of the lead even in
difficult-to-access veins of varying sizes. A lead is an insulated wire
that carries the heart signal to the implanted device and delivers energy
from the device to the heart. In most cases, leads are passed into the
heart through veins.
"The ability to place a left ventricular lead precisely where it will
stimulate the heart most effectively is a key factor in providing patients
with optimal cardiac resynchronization therapy," said Fred Colen, Executive
Vice President, Operations and Technology, Boston Scientific Cardiac Rhythm
Management. "ACUITY Spiral has the smallest lead tip profile in the
industry and offers physicians the flexibility to place the lead in veins
they may have avoided in the past."
The ACUITY Spiral lead is Boston Scientific's seventh U.S. or European
regulatory approval in the past nine weeks. The ACUITY Spiral lead is
pending approval by the U.S. Food and Drug Administration and is not
available for sale in the United States.
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, statements
regarding our product performance, regulatory approval of our products, new
product launches, competitive offerings, our growth strategy, 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 1A-
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.
Boston Scientific Corporation
http://www.bostonscientific.com
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