The U.S. FDA today approved the world’s smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). This is 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. Comparable in size to a large vitamin, the Micra TPS is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats, and nearly 1 million people worldwide are implanted with pacemakers each year. The leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions.
The Micra device is manufactured by Medtronic, located in Mounds View, Minnesota.