FDA Advisory Panel Unanimously Recommends Expanded Indication for Boston Scientific's Heart Failure Devices Based on Landmark MADIT-CRT Trial
By Boston Scientific Corporation, PRNEMonday, March 22, 2010
Company's CRT-Ds Recommended for Asymptomatic and Mild Heart Failure Patients
NATICK, Massachusetts, March 23, 2010 - Boston Scientific Corporation (NYSE: BSX) today announced that the
Circulatory System Devices Panel of the U.S. Food and Drug Administration
(FDA) has unanimously recommended approval of an expanded indication for its
cardiac resynchronization therapy defibrillators (CRT-Ds), including the
COGNIS(R) CRT-D. The panel recommended the expansion include the majority of
the studied population of the landmark MADIT-CRT clinical trial, which
evaluated the ability of these devices to slow the progression of heart
failure in patients with asymptomatic or mild heart failure.
"Boston Scientific welcomes the panel's decision to recommend expanding
the current indication to include the majority of the MADIT-CRT population,"
said Hank Kucheman, Executive Vice President and Group President, Cardiology,
Rhythm and Vascular for Boston Scientific. "If an expanded indication is
approved by the FDA, many additional heart failure patients would be eligible
for this therapy, which has been clinically proved to slow the progression of
this severe and life-limiting condition."
If approved, Boston Scientific would become the only company with an
FDA-approved CRT-D for high-risk New York Heart Association (NYHA) Class I
and II [1] patients with Left Bundle Branch Block (LBBB) morphology and sinus
rhythm. These patients accounted for 70 percent of the MADIT-CRT population.
Currently, heart failure patients must be defined as NYHA Class III or IV to
be indicated for a CRT-D device.
In response to a request from the FDA, Boston Scientific worked with the
MADIT-CRT Executive Committee to perform an extensive subgroup analysis of
the trial data. The subgroup analysis showed that a simple finding on an
electrocardiogram of LBBB was the best baseline characteristic in the trial
to predict which asymptomatic or mild heart failure patients were most likely
to benefit from a CRT-D.
LBBB is a condition in which the activation of the left ventricle is
delayed. As a result, portions of the left ventricle contract later than the
rest of the left ventricle and right ventricle, reducing the heart's pumping
ability. The intent of cardiac resynchronization therapy is to restore
synchronous contraction of the ventricles. Sinus rhythm refers to the normal
electrical activation of the upper chambers of the heart.
Results of the MADIT-CRT trial were published in the October 2009 issue
of the New England Journal of Medicine. The primary endpoint showed that
Boston Scientific's 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 heart failure patients, when compared to standard
implantable cardioverter defibrillators (ICDs) (p< 0.001). In addition, data
presented to the panel demonstrated that CRT-Ds reduced the relative risk of
heart failure events by 42 percent when compared to ICD therapy. 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 worldwide.
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:
www.bostonscientific.com.
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contained in this document.
[1] MADIT-CRT patients are asymptomatic or mildly symptomatic, NYHA Class
I (ischemic) and Class II (ischemic and non-ischemic). High-risk is defined
as QRS width >130 milliseconds and Left Ventricular Ejection Fraction < 30%.
The NYHA 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.
Geraldine Varoqui, Director International Public Relations, Tel: +49-2102-489-461, Mobile: +49-170-782-85-58, varoquig at bsci.com
Tags: Boston Scientific Corporation, March 23, Massachusetts, Natick