Medtronic’s Micra AV Transcatheter Pacing System Approved in Japan

January 10, 2022—Medtronic announced it has received approval from Japan’s Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micra AV transcatheter pacing system (TPS). Medtronic will launch the product this month.

The Micra AV is indicated for the treatment of patients with atrioventricular (AV) block. The Micra TPS is a leadless pacemaker; its first version (the Micra VR) was approved in Japan in 2017 for patients who only require single-chamber pacing.

According to Medtronic, the Micra AV approval is based on data from the MARVEL 2, 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.

Kyoko Soejima, MD, professor of cardiovascular internal medicine at Kyorin University Hospital in Tokyo, Japan, is a member of the Micra TPS Global Clinical Trial steering committee.

Dr. Soejima commented in Medtronic’s press release, “Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring. The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium.”

In 2020, Medtronic announced FDA approval and CE Mark approval for the Micra AV TPS.

The Micra AV, which is identical in size and shape to the original Micra TPS (comparable in size to a large vitamin), features several additional 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, stated Medtronic.