FDA Grants Expanded Approval for Medtronic Defibrillator

Medtronic Inc. has received approval for an expanded indication from the U.S. Food and Drug Administration (FDA) for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. Previously, the CRT-D devices were approved for use only in more serious cases of heart failure risk; now, the devices can be used earlier to treat mildly symptomatic heart failure patients. This potentially could improve survival rates, reduce hospitalizations, and prevent the heart condition from worsening.

The REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) clinical trials were the basis for the expanded FDA approval. The trials, initiated in 2005, demonstrated the benefit of using CRT-D devices in patients earlier, showing that this can reduce mortality rates.

REVERSE studied 610 patients and was the first large-scale, global, randomized, double-blind trial to demonstrate the impact of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. In the trial, the CRT delayed the time to first heart failure hospitalization in this patient group and reduced heart failure hospitalization or all-cause death by 51 percent. RAFT patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any study of CRT therapy. The trial demonstrated a 29 percent reduction in mortality in patients who used the CRT-D, and a 27 percent reduction in combined mortality and heart failure hospitalizations for this population.

“The RAFT and REVERSE study findings provide strong clinical evidence validating the safety, efficacy and lifesaving benefits of CRT-D for treating systolic heart failure patients with milder symptoms,” said Michael R. Gold, M.D., Ph.D., REVERSE study investigator and Michael E. Assey, M.D., steering committee member and professor of medicine and director of cardiology at the Medical University of South Carolina. “This expanded indication fulfills an unmet need by treating these patients in the earlier stages of heart failure, before their symptoms more significantly impact their quality of life.”

Certain New York Heart Association Class II patients, who now are eligible for CRT-D devices, previously only were able to get an implantable cardioverter defibrillator to protect them from sudden cardiac arrest, a condition responsible for more than 60 percent of deaths among the mild-to-moderate heart failure population.

Minneapolis, Minn.-based Medtronic Inc. is focused on the cardiovascular and spinal device sectors.