Medtronic’s Micra AV Transcatheter Pacing System (TPS) has won approval and reimbursement from Japan’s Ministry of Health, Labor and Welfare. Now the Dublin-based company said it will fully launch the device.
Medtronic said the Micra AV TPS was indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart are impaired.
The first version of the technology won approval in Japan in 2017 for patients who only require single-chamber pacing.
The Micra AV approval is 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.
Medtronic developed the Micra device. Its original version, the Micra VR, received CE Mark in 2015 and U.S. FDA approval in 2016.
“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,” said Rob Kowal, chief medical officer, Medtronic Cardiac Rhythm Management.