Medtronic clinches Japanese regulatory approval for Micra AV pacemaker

JAPAN – Medtronic plc, a global leader in healthcare technology, announced today that the Micra AV Transcatheter Pacing System (TPS) has been approved for sale and reimbursement by Japan’s Ministry of Health, Labor, and Welfare, and that the product will be available this month.

This approval expands the number of patients eligible for the Micra TPS, the world’s smallest pacemaker, in Japan, one of the world’s largest markets.

The Micra AV is intended for the treatment of patients suffering from AV block, a condition in which electrical signals between the chambers of the heart (the atria and the ventricle) are impaired.

In 2017, the first version of the technology (the Micra VR) was approved in Japan for patients who only needed single-chamber pacing.

Patients with AV block have traditionally 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 via thin wires known as “leads.”

Micra AV is the same size and shape as the original Micra TPS, but it has several additional algorithms that detect cardiac movement, allowing the device to adjust ventricle pacing to coordinate with the atrium, providing “AV synchronous” pacing therapy to patients with AV block.

The Micra AV was approved based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which assessed the safety and efficacy of accelerometer-based atrial sensing algorithms.

The study looked at the Micra’s internal sensor’s ability to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, resulting in atrioventricular synchrony (AV synchrony).

The Micra device was created by Medtronic. Its original version, the Micra VR, received CE Mark in 2015 and the system was first approved by the FDA in 2016.

The product is about the size of a vitamin pill and is implanted inside the right ventricle of the heart using a catheter, eliminating the need for leads to be run to the heart.

Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients,” Medtronic CMO of the Cardiac Rhythm Management business Dr. Rob Kowal said in the release.

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