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

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.  This makes Boston Scientific the only manufacturer with cardiac resynchronization therapy defibrillator devices approved for all types of NYHA classes of heart failure."

MRG's Global Markets for Cardiac Rhythm Management Devices 2011 report provides critical insight into trends that will fuel and limit market growth for cardiac rhythm management devices in the US, Europe (France, Germany, Italy, and the UK), and Japan. The report includes a breakdown of unit volumes, average selling prices, and market values for pacemakers (single-chamber, dual-chamber, and cardiac resynchronization therapy pacemakers) and implantable defibrillators (single-chamber, dual-chamber, and cardiac resynchronization therapy defibrillators).

About Millennium Research Group

Millennium Research Group (www.MRG.net), a Decision Resources, Inc. company (www.DecisionResourcesInc.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer behavior tracking, facility-level procedure forecasting, and customized solutions.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information, and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

SOURCE Millennium Research Group

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