Four patients who wore the LifeVest experienced sudden cardiac arrest and received a shock that successfully restored a life-sustaining heartbeat according to the FDA
ZOLL Manufacturing’s LifeVest is a wearable cardioverter defibrillator for children which has recently been approved by the US Food and Drug Administration (FDA).
LifeVest has been developed for children who are at risk of 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 that 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 wearable device weighs less than two pounds and consists of two main components: an electrode belt and garment that surround the patient’s chest in addition to a monitor that the patient wears around his or her waist.
This 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 8 year old.
Vasum Peiris, chief medical officer of pediatrics and special populations in the FDA’s Center for Devices and Radiological Health, said: “The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients.
”Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”
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.