The FDA expanded the indication for biventricular pacing using two types of cardiac resynchronization therapy devices to treat patients with atrioventricular block and mild to moderate heart failure (HF).
The agency approved an application from Minneapolis-based Medtronic to revise the labeling for two cardiac resynchronization therapy-pacemakers (CRT-P) and eight cardiac resynchronization therapy-defibrillators (CRT-D). The FDA previously had approved these devices for patients with more severe heart failure.
Approvals were based on results from BLOCK HF (Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block), a prospective, multicenter, randomized, double-blind trial that compared two pacing treatments for patients with atrioventricular block, left ventricular ejection fraction of 50 percent or less and New York Heart Association class I, II or III symptoms for HF. The study showed that patients who received biventricular pacing as a whole had better outcomes than those who received conventional right ventricular pacing.
The devices are expected to reduce HF-related urgent-care hospital visits and improve cardiac function compared with right ventricular pacing alone.
The approved devices are:
- Consulta CRT-P
- Consulta CRT-D
- Syncra CRT-P
- Maximo II CRT-D
- Concerto II CRT-D
- Viva XT CRT-D
- Viva S CRT-D
- Protecta CRT-D
- Protecta XT CRT-D
- Brava CRT-D