FDA expands indication of Medtronic pacemakers and defribillators

Medtronic, Inc. announced that the FDA approved an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D). Medtronic CRT devices are now approved to treat patients with atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, reducing heart failure hospitalizations and mortality, and improving cardiac function in these patients.

The expanded indication allows patients designated as New York Heart Association (NYHA) Class I, II and III with AV block that are expected to require a high percentage of ventricular pacing, and who have an ejection fraction (measure of the heart's pumping ability) less than or equal to 50 percent, to receive BiV pacing via Medtronic CRT devices. The FDA's approval was based on the landmark BLOCK HF clinical trial, which demonstrated significant clinical advantages of BiV pacing compared with traditional right ventricular (RV) pacing in this patient population, including a 27 percent relative risk reduction in the composite study endpoint of heart size, heart failure hospitalizations and mortality.