FDA approves first leadless pacemaker to treat heart rhythm disorders

FDA approves first leadless pacemaker to treat heart rhythm disorders

The U.S. Food and Drug Administration approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.

Helene Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration