INDIA – Medtronic private limited, a global leader in medical technology, services, and solutions, has launched Micra AV the world’s first miniature-sized pacemaker.
Micra AV is the first pacemaker that can sense atrial activity without a lead or device in the upper chamber of the heart.
The new innovation 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.
Micra AV provides Atrioventricular (AV) synchronous pacing therapy to patients with AV block, a type of heart block that occurs when the electrical signal traveling from the atria, or the upper chambers of the heart, to ventricles, or the lower chambers of the heart, is impaired.
Previously, patients with AV block have been treated with traditional dual-chamber pacemakers implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called “leads.”
Pacemakers have also been used to manage Bradycardia, a condition characterized by a slow or irregular heart rhythm.
With this condition, the heart is unable to pump enough oxygen-rich blood to the body during normal activity or exercise, causing dizziness, fatigue, shortness of breath or fainting spells.
Through the United States Food and Drug Administration, Micra AV received approval based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study that 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 showed the primary efficacy objective was met.
Additionally, the device passed the safety test as no pauses nor episodes of pacing-induced tachycardia were reported during algorithm mediated AV synchronous pacing.
Medtronic has been in the innovative space since the days of its first ever battery powered pacemaker in 1957 to the latest Micra AV pacemaker.
Its recent device will help patients suffering from complete heart block opt for the option of a leadless device that is delivered through a minimally invasive procedure and is cosmetically invisible to the patient.