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

Wed, 10/06/2010 - 6:31am
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.

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