Video: MADIT-CRT Trial Results Provide Clinical Evidence That Cardiac Resynchronization Therapy Significantly Slows Heart Failur
01 Septiembre 2009 - 1:00AM
PR Newswire (US)
Results of landmark heart failure trial published by New England
Journal of Medicine and presented at ESC NATICK, Mass., and
BARCELONA, Spain, Sept. 1 /PRNewswire/ -- Boston Scientific
Corporation (NYSE:BSX) today announced final results from the
landmark MADIT-CRT trial, which were published by the New England
Journal of Medicine and presented during a Hot Line session at the
annual European Society of Cardiology (ESC) Congress in Barcelona.
To view the Multimedia News Release, go to:
http://www.prnewswire.com/mnr/bostonscientific/36500/ (Photo:
http://www.newscom.com/cgi-bin/prnh/20090901/NY68733 ) Arthur Moss,
M.D., Professor of Medicine at the University of Rochester Medical
Center and Principal Investigator of the trial, presented the
MADIT-CRT data. The primary endpoint showed that Boston
Scientific's cardiac resynchronization therapy defibrillators
(CRT-Ds) were associated with a 34 percent relative reduction in
the risk of all-cause mortality or first heart failure event in
asymptomatic and mild (NYHA Class I and II(1)) heart failure
patients, when compared to standard implantable cardioverter
defibrillators (ICDs) (p=0.001). In addition, MADIT-CRT data showed
that: -- CRT-D therapy reduces the relative risk of heart failure
events by 41 percent when compared to ICD therapy (p< 0.001). --
Patients treated with CRT-D therapy showed an improvement of 11
percent in Left Ventricular Ejection Fraction(2) after one year,
compared to a three percent improvement for ICD patients. "The
MADIT-CRT Executive Committee anticipated that the benefit for the
CRT-D therapy group would be dominated by a reduction in heart
failure events and the data overwhelmingly confirm that," said Dr.
Moss. "Furthermore, CRT-D therapy showed an equal benefit in both
ischemic and non-ischemic(3) patients. The MADIT-CRT data are
compelling and help bridge a clinical gap in our understanding of
heart failure in Class I and II patients." "The publication of the
manuscript by the New England Journal of Medicine and the
presentation of MADIT-CRT data at ESC highlight the importance of
this study, which clearly demonstrates that CRT-D therapy slows the
progression of heart failure, further delaying the onset of more
severe and life-limiting conditions," said Fred Colen, President,
Boston Scientific Cardiac Rhythm Management. "We look forward to
working with the FDA as we seek approval for an expanded indication
for our CRT-D devices, based on these strong results." MADIT-CRT is
the world's largest randomized study of NYHA Class I and II
patients, with more than 1,800 patients enrolled at 110 centers in
14 countries. Currently, heart failure patients must be defined as
NYHA Class III or IV to be indicated for CRT-D therapy. However,
approximately 70 percent of all heart failure patients in the U.S.
fall into Class I or II. Nearly 22 million people worldwide,
including more than 5.5 million Americans, suffer from some form of
heart failure. MADIT-CRT is an important continuation of Boston
Scientific's exclusive sponsorship of landmark clinical trials that
have broken new ground and helped improve outcomes for high-risk
cardiac patients worldwide. More than 80 percent of U.S. patients
who receive an ICD or CRT-D were first indicated for this
life-saving therapy through clinical research(4) sponsored by
Boston Scientific. 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
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"intend" and similar words. These forward-looking statements are
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of future events or performance. These forward-looking statements
include, among other things, statements regarding our product
performance, clinical outcomes, regulatory approval of our
products, and our growth strategy. 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. (1)
MADIT-CRT patients are high risk (asymptomatic or mildly
symptomatic, New York Heart Association Class I and II). High-risk
is defined as QRS width greater than or equal to 130 milliseconds
and Left Ventricular Ejection Fraction less than or equal to 30%.
The New York Heart Association clinical classifications of heart
failure patients rank patients as Class I-II-III-IV, according to
the degree of symptoms or functional limits, from asymptomatic to
bed ridden. (2) Left Ventricular Ejection Fraction (LVEF) is a
measurement of how well the heart is pumping. People with healthy
hearts usually have an LVEF of greater than or equal to 50%.
Patients who were candidates for the MADIT-CRT study had an LVEF of
less than or equal to 30%. (3) Ischemic patients suffer from
Coronary Artery Disease (CAD). (4) Trials include MADIT, MADIT-II,
CONTAK-CD, and COMPANION. Press Contact: Paul Donovan 508-650-8541
(office) 508-667-5165 (mobile) Media Relations Boston Scientific
Corporation David Knutson 651-260-8288 (mobile) Media Relations
Boston Scientific Corporation Larry Neumann 508-650-8696 (office)
Investor Relations Boston Scientific Corporation
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Site: http://www.bostonscientific.com/
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