Medtronic, Inc. (MDT) said that the FDA approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator, or CRT-D, devices. 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 percent, left bundle branch block, and a QRS duration greater than or equal to 130 milliseconds.
The company specified that the FDA's decision for the expanded indication rests on data from the pivotal REVERSE and landmark RAFT clinical trials, which demonstrated that CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.
With today's approval, the advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations, and preventing disease progression.
by RTT Staff Writer
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