FDA approves wearable defibrillator for children at risk for sudden cardiac arrest

The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.

While many automated external defibrillators (which require a second person to operate them) have been cleared for use in children, LifeVest is the only one worn by the patient and monitors the heart continuously for abnormal, life-threatening heart rhythms (arrhythmias). LifeVest responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.

Helene Clayton-Jeter, OD
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network