Health Canada approves Micra AV pacemaker for AV Block.- Medtronic

Medtronic Canada announced that it has received a Health Canada licence for Micra AV, the world's smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical connection between the atria and the ventricle is impaired. Medtronic's technology is the first Health Canada-licensed leadless pacemaker device. The Micra AV includes internal atrial sensing algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.Approval is based on the MARVEL 2 study which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. MARVEL 2 assessed 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, showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having more than 70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P > 70% synchrony). 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. The study was published in JACC: Clinical Electrophysiology.See: "Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study." Clemens Steinwender et al. J Am Coll Cardiol Clin Electrophysiol. 2020 Jan, 6 (1) 94–106 doi/full/10.1016/j.jacep.2019.10.017