Medtronic landed the CE Mark of approval to introduce its Micra pacemaker in Europe. This is the world’s smallest pacemaker, and because it’s implanted via transfemoral route completely inside the heart it doesn’t need or use cardiac leads. Moreover, there’s no need to create a chest pocket for the pacemaker to reside in, avoiding many of the complications related to that.
The device is attached directly to the heart using tines, with the electrode at the tip delivering the pacing signals. It can be repositioned as needed, or removed for any reason.
The Micra has already been implanted in initial patients in the U.S., though it is still considered an investigational device by the FDA.
From the announcement:
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 for the first time at a late-breaking clinical trials session at the Heart Rhythm Society’s 2015 Annual Scientific Sessions in May.