FDA www.fda.gov has approved a wearable defibrillator called LifeVest for children at risk for sudden cardiac arrest but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
Many automated external defibrillators have been cleared for use in children. However, LifeVest is the only defibrillator worn by the patient that monitors the heart continuously for abnormal life-threatening heart rhythms. LifeVest responds automatically if it senses the need to deliver a shock and restores a life sustaining heartbeat.
Weighing less than two pounds, the device consists of two main components to include an electrode belt and garment that surrounds the patient’s chest and a monitor that the patient wears around their waist. The device is intended only for children that weigh at least 41 pounds and have a chest size of 26 inches or more, about the size of an average eight old.
The LifeVest defibrillator is manufactured by the ZOLL Manufacturing Corporation www.zoll.com based in Pittsburgh. The pediatric approval was based on published studies and company registry containing clinical information from 248 patients from three to seventeen at risk for sudden cardiac arrest. No additional safety concerns were identified and four patients that experienced sudden cardiac arrest received a shock that successfully restored a life sustaining heartbeat.