The US Food and Drug Administration (FDA) approved an application from Medtronic for revised labelling for two cardiac resynchronisation pacemakers (CRT-P) and eight cardiac resynchronisation defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.
The FDA previously approved these devices for patients with more severe heart failure as evaluated by their physician using specific criteria. The new approved use includes patients with less severe heart failure, but who are already indicated to receive right ventricular pacing. With the new indication, these patients will be eligible to receive a device that will pace both sides of their heart instead of just the right.
“Medtronic’s cardiac resynchronisation therapy pacemakers and defibrillators can delay the occurrence of heart failure-related urgent care visits for people who meet these new criteria,” says Christy Foreman, director of the Office of Device Evaluation in the FDA’s Centre for Devices and Radiological Health. “This approval expands the indication of cardiac resynchronisation therapy to this additional patient population.”
The expanded approval for the CRT-D and CDT-P devices was based on data from the Block HF clinical study that compared death, heart failure-related urgent care visits and increases in left ventricular end systolic volume index (LVESVI) in study subjects who received either left and right ventricular pacing, or right ventricular pacing alone. Left ventricular end systolic volume index is a diagnostic measure of cardiac structure and function. A total of 918 subjects participated in the trial, 531 of whom received a CRT-P device and 227 of whom received a CRT-D device. The study showed that the cardiac resynchronization 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 left ventricular end systolic volume index compared to right ventricular pacing alone.
The expanded device approvals are for the following devices manufactured by Medtronic:
Maximo II CRT-D
Concerto II CRT-D
Viva XT CRT-D
Viva S CRT-D
Protecta XT CRT-D