Japan's Ministry of Health, Labor, and Welfare has approved Medtronic plc's (NYSE:MDT) Micra AV Transcatheter Pacing System (TPS). The Company will launch the product this month.
- The Micra AV is indicated for patients with AV block, a condition in which the electrical signals between the heart's chambers are impaired.
- Related: Medtronic's Evolut Pro TAVR Approved In China, Acquires Cardiac Arrhythmia Treatment Developer Affera.
- The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved in Japan in 2017 for patients who only require single-chamber pacing.
- The Micra TPS received CE Mark in April 2015 and the FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers.
- The device is attached to the heart with small tines during the implant procedure and delivers electrical impulses.
- Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device.
- Price Action: MDT shares are up 0.01% at $105.62 during the premarket session on the last check Tuesday.
