The device is 93 per cent smaller than conventional pacemakers
India Medtronic has launched Micra AV – a miniaturised and fully self-contained pacemaker that delivers advanced pacing technology to atrioventricular (AV) block patients via a minimally invasive approach. The device is the first pacemaker that can sense atrial activity without a lead or device in the upper chamber of the heart, a company statement said.
Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called ‘leads.’ Identical in size and shape to the original Micra Transcatheter Pacing System (TPS), Micra AV is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Micra AV has several additional 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.
“Medtronic is known to invent, innovate and disrupt – whether it was the first battery-powered pacemaker in 1957 or the latest Micra AV pacemaker. Now, with Micra AV, patients suffering from complete heart block have the option for a leadless device that is delivered through a minimally invasive procedure and is cosmetically invisible to the patient,” said Abhishek Bhargava, Director, Cardiac Rhythm Management, Cardiac Ablation and Diagnostics at Medtronic India.
The statement also notified that Micra AV has received United States Food and Drug Administration (FDA) approval 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 per cent AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95 per cent) than VVI pacing (0 patients, P<0.001 for proportion of patients with ≥70 per cent 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,” added the statement.