Zoll Manufacturing Corporation's LifeVest wearable defibrillator was approved by the Food and Drug Administration (FDA) Dec. 17 for children at risk of sudden cardiac arrest.
The device continuously monitors the user's heart and delivers a shock to restore a normal heart rhythm if a life-threatening heart rhythm is detected. Ventricular fibrillation or ventricular tachycardia is the most-common cause of sudden cardiac arrest with conditions, such as heart disease and heart-related structural changes, also playing a part. As sudden cardiac arrest is likely to result in death in a manner of minutes, defibrillators can provide quick treatment to increase a person's survival rate.
The LifeVest is lightweight and is intended for use in children who can't use an implantable defibrillator because of either medical conditions or non-consent from their parents. Children must weigh at least 41 pounds and have a chest size of at least 26 inches.
The wearable defibrillator has already been approved for use in individuals aged 18 and older.
“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” Vasum Peiris, chief medical officer of pediatrics and special populations in the FDA's Center for Devices and Radiological Health, said. “Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”