Medtronic’s Micra AV TPS Gains Japanese Approval

Medtronic received approval from Japan’s Ministry of Health, Labor and Welfare for sale and reimbursement of its Micra AV Transcatheter Pacing System (TPS). The company aims to launch the product there this month.
 
Micra AV treats patients with AV block, when electrical signals between the heart’s chambers are impaired. Micra TPS is the first-ever leadless pacemaker.
 
“Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring,” Kyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee told the press. “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.”
 
AV block patients were typically treated with dual-chamber pacemakers implanted in the upper chest, under the skin below the collarbone, and connected to the heart with thin wires. Micra AV’s algorithms detect cardiac movement so the device can adjust ventricle pacing to coordinate with the atrium for “AV synchronous” pacing therapy.
 
The approval is based on MARVEL 2 study data evaluating accelerometer-based atrial sensing algorithms. The study assessed Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle.
 
“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, M.D., Ph.D., chief medical officer of Medtronic’s Cardiac Rhythm Management business.