WASHINGTON, DC — The US Food and Drug Administration (FDA) has approved 10 Medtronic biventricular pacemakers, some with defibrillators and some without, for use in patients with "less severe" systolic heart failure and atrioventricular block indicating a need for right ventricular pacing, the agency announced today. The announcement follows the October 2013 recommendations from its Circulatory System Devices panel that the devices are safe, effective, and approvable for that indication based on the results of the randomized BLOCK-HF trial, as covered by heartwire .
The approvals expand the labeling on the defibrillating and pacing-only cardiac resynchronization therapy devices (CRT-D and CRT-P, respectively), which until now had been approved only for heart-failure patients with LVEF <35% and prolonged QRS intervals. The BLOCK-HF indications included a different niche of patients, those with first-, second-, or third-degree AV block, NYHA class 1-3 heart failure, and LVEF <50%.
The trial had randomized 691 such patients to receive three-lead CRT-D or CRT-P devices programmed to either biventricular pacing or to standard RV pacing. Over a mean of three years, as heartwire previously reported, the biventricular-paced group showed a significant 26% drop in the primary end point of all-cause mortality, HF-related urgent care, or a >15% increase in LV end-systolic volume index (LVESVI). The benefit was driven almost entirely by improvements in HF-related urgent care and LVESVI.
The new approvals apply to the following Medtronic devices: Consulta CRT-P and CRT-D, Syncra CRT-P, Maximo II CRT-D, Concerto II CRT-D, Viva XT CRT-D and S CRT-D, Protecta CRT-D and XT CRT-D, and Brava CRT-D.
Heartwire from Medscape © 2014
Cite this: FDA Approves Medtronic CRT Devices for Mild HF With AV Block - Medscape - Apr 10, 2014.