Medtronic (MDT) Gets FDA Nod For Micra AV To Treat AV Block
Zacks Investment Research | Jan 21, 2020 10:01PM ET
Medtronic plc (NYSE:MDT) received the FDA’s approval for its latest innovation within the Micra product line — Micra AV — which is the world’s smallest pacemaker with atrioventricular (AV) synchrony to date. The Micra AV is the first and only FDA-approved leadless pacemaker, which is currently offered by the company for the treatment of patients with AV block. Notably, AV block is a condition, where the electrical signals between the heart chambers (the atria and the ventricle) are hampered.
Per the medical fraternity, with the approval of the device, more pacemaker patients will be eligible for a new treatment option. Notably, the regulatory approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, assessing the safety and effectiveness of accelerometer-based atrial sensing algorithms.
Further, the favorable results obtained were presented at the American Heart Association 2019 Scientific Sessions and published in JACC: Clinical Electrophysiology.
With the approval, Medtronic aims to strengthen its Cardiac and Vascular Group segment globally. Notably, in 2016, the FDA approved the first device from the Micra product line — Micra Transcatheter Pacing System (TPS) — the first leadless pacemaker to treat heart rhythm disorders.
Significance of the Latest Approval
The FDA clearance is significant since Micra AV is the only pacemaker offering advantages of leadless pacing. The latest device is superior to the traditional pacemaker devices as it involves a minimally invasive implant procedure of a cosmetically invisible device.
Even though the chances of complications with traditional devices are rare, they do involve costly and invasive surgery. However, the use of Micra has shown a substantial drop in major complications, unlike its traditional counterparts.
Another advantage of Micra AV over the original Micra TPS is that it has several additional internal atrial sensing algorithms, which can detect cardiac movement. This allows the device to adjust pacing in the ventricle to coordinate with the atrium, thus, providing AV synchronous pacing therapy to patients with an AV block.
Industry Prospects
Per a report by Zacks Investment Research
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