Japan’s approval for the Micra AV transcatheter pacing system (TPS) covers the sale and reimbursement of the platform. Medtronic plans to launch the product in the country this month.
According to a news release, Micra AV’s indication covers the treatment of patients with AV (atrioventricular) block, a condition that impairs the electrical signals between the chambers of the heart (the atria and the ventricle). Medtronic said the Micra TPS is the first-ever leadless pacemaker, with the original Micra VR version approved in Japan in 2017 for patients who only require single-chamber pacing.
Micra AV uses several algorithms to detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium and provide AV-synchronous pacing therapy to patients with AV block. Approval came on the back of data from the Marvel 2 study of the safety and effectiveness of accelerometer-based atrial sensing algorithms.
“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.