Medtronic ‘Smallest’ Pacemaker w/AV Synchrony OK’d

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.”