FDA approves pediatric LifeVest wearable cardioverter defibrillator- Zoll Medical Corporation

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