Mumbai (Maharashtra) [India], June 16 (ANI/BusinessWire India): India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE:MDT), today announced the launch of Micra™ AV - a miniaturized, 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.
Bradycardia is a condition characterized by a slow or irregular heart rhythm, usually fewer than 60 beats per minute (normal heart rate is 60 - 100 bpm). At this rate, 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.
Atrioventricular block (AV block) is a type of heart block in which the electrical signals between the chambers of the heart (the atria and the ventricles) are impaired. Pacemakers, the most common way to treat bradycardia and AV block, help restore the heart's normal rhythm and relieve symptoms by sending electrical impulses to the heart to increase the heart rate.
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 & Diagnostics at Medtronic India. "We remain firmly committed to introducing innovations that alleviate pain, restore health and extend lives of patients in India."
Micra AV received United States Food and Drug Administration 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% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P<0.001 for 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 algorithm mediated AV synchronous pacing.
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