FDA Approves Zoll's LifeVest Defibrillator for Children at Risk for Sudden Cardiac Arrest

December 22, 2015—The US Food and Drug Administration (FDA) announced last week that it approved a new indication for the LifeVest wearable cardioverter defibrillator (Zoll Manufacturing Corporation). The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but who are not candidates for an implantable defibrillator because of certain medical conditions or lack of parental consent.

According to the FDA, although 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 arrhythmias. LifeVest responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.

The device weighs less than two pounds and consists of two main components: an electrode belt and garment that surround the patient’s chest, and a monitor that the patient wears around their waist. This device is intended only for children who weigh at least 41 pounds and have a chest size of 26 inches or more, which is approximately the size of an average 8-year-old child.

The device was first approved in 2001 for patients 18 years of age and older. Later models of the device were approved for patients 18 years of age and older in 2002, 2006, and 2009.

The new pediatric approval was based on published studies and a company registry containing clinical information from 248 patients, ages 3 to 17 years, at risk for sudden cardiac arrest. The FDA stated that no additional safety concerns were identified, and four patients who experienced sudden cardiac arrest received a shock that successfully restored a life-sustaining heartbeat.