The FDA has approved an expanded indication for Medtronic's cardiac resynchronization therapy with implantable cardioverter-defibrillator (CRT-D) devices.
With this approval, the therapy can now be used earlier, in a mildly symptomatic heart failure (HF) patient population, according to the Minneapolis-based company.
The expanded indication includes New York Heart Association (NYHA) Class II HF 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 ms. Medtronic CRT-D devices were previously indicated to treat certain patients with moderate-to-severe HF (NYHA Class III and IV).
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.
While certain NYHA Class II patients are already indicated for an implantable cardioverter-defibrillator to protect them from sudden cardiac arrest, they are still vulnerable to experiencing an exacerbation of their HF, Medtronic said. The device also has defibrillation capability, allowing for termination of ventricular arrhythmias.
The company will embark on a post-approval study to assess the clinical benefits of CRT-D treatment in the Class II HF patient population.