Medtronic PLC’s cardiac resynchronization therapy-defibrillator devices gained PMA supplement approval April 10 to include heart failure patients with milder symptoms on product labeling. The expanded indication includes New York Heart Association Class II heart failure patients with a left ventricular ejection fraction of less than or equal to 30%, a defect called left bundle branch block, and a QRS duration of greater than or equal to 130 milliseconds. The CRT-Ds were previously approved to treat certain patients with moderate-to-severe (Class III and IV) heart failure. The labeling expansion received endorsement from an FDA panel last December. (See Also see "FDA Panel Supports Expanded Indications For Medtronic CRT-D Devices" - Medtech Insight, 12 December, 2011..)
Medtronic notes that 200,000 Americans have Class II heart failure. However, certain Class II patients are already indicated for an implantable cardioverter defibrillator to protect them from sudden cardiac arrest....
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