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Positive Results From the MADIT-CRT Trial Support the Expanding Approval of Cardiac Resynchronization Therapy Defibrillators

October 6, 2010 By Bio-Medicine.Org

TORONTO, Oct. 6 /PRNewswire/ — According to Millennium Research
Group (MRG), the global authority on medical technology market
intelligence, growth in the $2 billion US cardiac resynchronization
therapy defibrillator market will be supported by the expanded
approval of Boston Scientific’s chronic resynchronization therapy
defibrillators in New York Heart Association class I and II
patients.

The New York Heart Association classification system ranks heart
failure patients according to different levels of severity, with
Class I being the least severe and Class IV the most severe.
Classes I and II are considered mild forms of heart failure with
relatively minor symptoms.  Classes III and IV are considered
to be moderate and severe forms of heart failure, and Class IV
patients experience discomfort at rest and very little physical
activity.

Cardiac resynchronization therapy defibrillator procedures will
grow due to results from the MADIT-CRT (Multicenter Automatic
Defibrillator Implantation Trial with Cardiac Resynchronization
Therapy) trial. MADIT-CRT was a randomized trial designed to
compare patients in New York Heart Association Class I or II who
received a cardiac resynchronization therapy defibrillator with
those who received an implantable cardioverter defibrillator; the
trial found patients who received a cardiac resynchronization
therapy defibrillator had a 34% reduction in the risk of heart
failure or death.

“As a result of this trial, in March 2010, an FDA panel of
cardiologists voted in favor of expanding the indication of cardiac
resynchronization therapy defibrillators to include mild heart
failure patients, increasing the potential patient pool,” says
Julie McLaughlin, Analyst at MRG.  “This decision was upheld
in September 2010 when the FDA expanded the indication for Boston
Scientific’s cardiac resynchronization therapy defibrillator
devices to include high risk New York Heart Association Class I and
II patients.

‘/>”/>

SOURCE

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