Dr. Philippe Ritter, cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire (CHU) Bordeaux said, "Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical 'pocket' under the skin, so potential sources of complications are eliminated - as are any visible signs of the device."
The chances of complications are more when a chest pocket for the pacemaker is created. Micra, does not need a pacemaker pocket. The device and the heart are attached directly using tines with the electrode at the tip delivering the pacing signals.
Based on results from the first 60 patients in the Medtronic Micra TPS Global Clinical Trial the device was awarded CE Mark. The trial is still ongoing and will continue to evaluate the safety of the device.