The FDA has approved the revised labeling for Medtronic’s 2 cardiac resynchronization pacemakers (CRT-P) and 8 cardiac resynchronization defibrillators (CRT-D) for use in patients with atrioventricular (AV) block and less severe heart failure.
These devices were approved previously for use in patients with more severe heart failure as assessed under specific criteria. This expanded indication includes patients with less severe heart failure but those who are already indicated to received right ventricle pacing. This approval allows eligible patients to receive a device that will now pace both sides of their heart.
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The FDA approval was based on data from the Block HF study that compared death, heart failure-related urgent care visits, and increases in left ventricular end systolic volume index (LVESVI) in 918 subjects who received either left and right ventricular pacing, or right ventricular pacing alone. Subjects were randomized to a CRT-P device (n=531) or a CRT-D device (n=227). Results showed that therapy provided by CRT-P and CRT-D devices results in a 27% reduction in death, heart-failure-related urgent-care visits, and increases in LVESVI vs. right ventricular pacing alone.
The approval affects the following Medtronic devices:
- 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
For more information call (800) 328-0810 or visit Medtronic.com.