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# Medtronic ‘Smallest’ Pacemaker w/AV Synchrony OK’d
- URL: https://www.fdaweb.com/medtronic-smallest-pacemaker-w-av-synchrony-okd/
- Published: 2020-01-21T12:00:00.000Z
- Updated: 2026-09-14T15:59:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145895

FDA has approved a Medtronic PMA for the Micra AV, which it describes as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The device is indicated for treating patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. It was approved based on data from the MARVEL 2 (Micra Atrial Tracking Using a Ventricular Accelerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms.

Study data showed that the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm after undergoing AV synchrony than single-chamber ventricular pacing patients, Medtronic says. “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.”