Pacemakers are intended to be used as a substitute for the heart’s intrinsic pacing system to correct cardiac rhythm disorders. Conventional pacemakers consist of two components: a pulse generator and electrodes (or leads). Pacemakers are considered life-sustaining, life-supporting class III devices for individuals with a variety of brady-arrhythmias. Even though the efficacy and safety profile of conventional pacemakers are excellent, in a small proportion of individuals, they may result in lead complications and the requirement for a surgical pocket. Further, some individuals are medically ineligible for conventional pacemakers due to lack of venous access and recurrent infection.
Leadless pacemakers are single-unit devices that are implanted in the heart via femoral access, thereby eliminating the potential for complications as a result of leads and surgical pocket. The Micra transcatheter pacing system is the only commercially available leadless pacemaker in the United States (U. S.) approved by the Food and Drug Administration (FDA).