FDA nod for Micra AV leadless pacemaker

March 6, 2020 0 By FM

Medtronic said it has received US FDA approval of Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. 

The device is indicated for the treatment of patients with AV block.

The Micra AV approval is 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. 

The study evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.

Results from the study, presented at the American Heart Association 2019 Scientific Sessions and published simultaneously in JACC: Clinical Electrophysiology, showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having >70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P<0.001 for the proportion of patients with >70% synchrony). 

The study’s primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during an algorithm mediated AV synchronous pacing, the company said.