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News From the Food and Drug Administration
May 17, 2016

Leadless Pacemaker Approved

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(19):2057. doi:10.1001/jama.2016.5595

A first-of-its-kind pacemaker that regulates heart rate without lead wires has received FDA approval. The Micra Transcatheter Pacing System is a self-contained, 1-inch-long device that is implanted directly into the heart’s right ventricle (http://1.usa.gov/23iwftQ).

In a traditional single-chamber pacemaker implanted under the skin near the collarbone, lead wires run from the device through a vein directly into the right ventricle. The leads deliver electric pulses to help coordinate the timing of contractions in the ventricle. But leads sometimes malfunction or cause complications if an infection develops in surrounding tissue, requiring surgery to remove the device.