The US Food and Drug Administration has approved Medtronic's Micra AV leadless pacemaker, which uses atrial-sensing algorithms to provide atrioventricular (AV) synchronous pacing, the company has announced.
The approval extends leadless pacing to patients with complete AV block, who would normally receive a conventional dual-chamber pacemaker. The device's first iteration, the Micra TPS, approved in 2016, delivers ventricle-only pacing without regard to the atrium.
After transcatheter implantation in the right ventricle, Micra AV provides an analog of dual-chamber pacing without leads through accelerometer sensing of right atrial contractions and appropriate timing of ventricular pacing.
Regulators okayed the device based on the results of the Micra Atrial Tracking Using a Ventricular Accelerometer (MARVEL 2) trial, in which significantly more patients with complete AV block who had their Micra devices programmed to dual-chamber mode, compared with single-chamber mode, achieved greater than 70% AV synchrony, Medtronic notes.
"The study's primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing," says the company announcement.
"Medtronic will begin training field personnel and physicians, and will activate a limited number of implanting centers in the coming weeks, with full launch anticipated later this spring," it states.
Cite this: FDA Approves Medtronic's Micra AV, Offers Leadless AV Synchronous Pacing - Medscape - Jan 22, 2020.