FDA approves world’s smallest pacemaker with AV synchrony

Medtronic announced Jan. 21 it had received FDA approval for its Micra AV device—the world’s smallest pacemaker with atrioventricular (AV) synchrony.

Micra AV is identical in size and shape to Medtronic’s original Micra Transcatheter Pacing System (TPS), which is a leadless pacemaker first approved back in 2016. The Micra TPS and AV devices are less than one-tenth the size of a conventional pacemaker—about the size of a large vitamin—but are able to deliver advanced pacing technology to patients via a less-invasive approach.

The Micra AV is indicated for the treatment of AV block, which occurs when the electrical signals between a person’s atria and ventricles are impaired. Its approval was based on positive results from the MARVEL 2 study, which evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and achieve AV synchrony between the heart’s chambers. The trial met its primary efficacy endpoint, finding that a significantly greater portion of complete heart block patients with normal sinus rhythm achieved 70% or greater AV synchrony during algorithm-mediated pacing.

“With the approval of Micra AV, more pacemaker patients qualify for a new treatment option that offers the advantages of leadless pacing, including a minimally invasive implant procedure and a cosmetically invisible device,” Larry Chinitz, MD, a cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center in New York City, said in a statement from Medtronic. “Although complications with traditional pacemakers are infrequent, when they occur, they’re expensive to treat and can be invasive for the patient. Real-world use of Micra has shown a 63% reduction in major complications compared to traditional pacemakers.”

According to its statement, Medtronic will begin training a team of field personnel and physicians to use the Micra AV immediately and will activate a limited number of implanting centers in the coming weeks. A full launch is anticipated later this spring.

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