Jan. 22, 202: U.S. FDA grants approval for Medtronic’s Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony for the treatment of patients with AV block. It is a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired.
Now Medtronic offers the first and only FDA-approved leadless pacemaker portfolio, expanding number of potential candidates for this groundbreaking technology in U.S.
In the past, patients with AV block have been treated with the traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin beneath the collar bone, and connected to the heart by using thin wires known as “leads.”
Micra AV has several additional internal atrial sensing algorithms which detect cardiac movement that allows device to adjust pacing in the ventricle in order to coordinate with the atrium, providing “AV synchronous” pacing therapy to the patients with the AV block.
The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study that evaluates the safety and effectiveness of accelerometer-based atrial sensing algorithms.
The study evaluated the ability of the Micra’s internal sensor in order to monitor and detect atrial contractions and facilitate coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.
About the Micra Transcatheter Pacing System (TPS)
Approved by the FDA in 2016, the Micra TPS is a leadless pacemaker option for the patients who only require pacing in the right ventricle.
Comparable in size to a large vitamin, Micra is less than one-tenth the size of the traditional pacemakers so far delivers advanced pacing technology to patients via a simply invasive approach.
During the implant procedure, the device 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.
