Medtronic CRT-D Indication Expanded to Treat Mild Heart Failure

REVERSE, RAFT clinical trials demonstrate reduction in mortality and heart failure hospitalization in new patient population

 

April 12, 2012

The U.S. Food and Drug Administration (FDA) in April 2012 approved an expanded indication for Medtronic’s cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. With the approval, this advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations and preventing disease progression.

The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation. Medtronic CRT-D devices were previously indicated to treat certain patients with moderate-to-severe heart failure (NYHA Class III and IV), and have safely and effectively been used in these patients for more than a decade.

The FDA’s decision for the expanded indication rests on data from the pivotal REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) clinical trials, which showed that CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.

While certain NYHA Class II patients are already indicated for an implantable cardioverter defibrillator (ICD) to protect them from sudden cardiac arrest (SCA), they are still vulnerable to experiencing an exacerbation of their heart failure. In fact, SCA is responsible for more than 60 percent of deaths among patients with mild-to-moderate heart failure. However, a growing body of clinical research suggests that earlier intervention with CRT-D can decrease the risk of morbidity and mortality in this mildly symptomatic patient population. CRT-D therapy works by resynchronizing the contractions of both ventricles by sending tiny electrical impulses to the heart muscles, which improves the heart’s blood-pumping ability. The device also has defibrillation capability, allowing for termination of life-threatening ventricular arrhythmias.

For more information:  www.medtronic.com

 

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