Published on 12 Jan 2022 on Zacks via Yahoo Finance
Medtronic (MDT) Gets MHLW Approval for Micra AV Sale in Japan
Medtronic plc MDT recently announced that the Micra AV Transcatheter Pacing System (TPS) has been approved for sale and reimbursement by Japan's Ministry of Health, Labor and Welfare (MHLW). The company is set to launch the product this month.
The Micra AV is used to treat patients who have atrioventricular (AV) block. It delivers the benefits of leadless pacing to a greater number of patients. The Micra AV is similar in shape and size to the original Micra TPS and features several additional algorithms to detect cardiac movement. This enables the device to adjust ventricle pacing to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.
The Micra AV authorization is backed by data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which examined the safety and effectiveness of accelerometer-based atrial sensing algorithms.