Micra Transcatheter Pacing System receives CE Mark Approval for Arrhythmias-Medtronic

Medtronic has received CE Mark approval for the Micra Transcatheter Pacing System (TPS), the world's smallest pacemaker, for use in treating Arrhythmias. Comparable in size to a large tablet, the Micra TPS does not require the use of wires, known as "leads," to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.

The device was awarded CE Mark based on results from the first 60 patients (at three months) in the Medtronic Micra TPS Global Clinical Trial. The trial is ongoing and will continue to evaluate the safety and efficacy of the device through a single-arm, multi-center study that will enroll up to 780 patients at approximately 50 centers in 20 countries. Initial results from the Micra TPS Global Clinical Trial will be revealed at a late-breaking clinical trials session at the Heart Rhythm Society's 2015 Annual Scientific Sessions in May.