The FDA has issued regulatory approval for ZOLL Medical’s LifeVest defibrillator system to be used with pediatric patients who are not candidates for an implantable defibrillator. Many children prone to suffering from cardiac arrest are either not good subjects for implants or their parents choose not to go that route. The LifeVest is a wearable external defibrillator that continuously monitors the heart for signs of dangerous arrhythmias. Once detected, much like an automatic external defibrillator (AED,) it delivers an electric shock to the patient.
Many AEDs are cleared for use on children, but the ZOLL LifeVest is the only one that doesn’t require a second person to operate. It weighs less than two pounds (1 Kg) and includes a vest that can hide under clothing and a controller that snaps at the waist.
The approval indication includes children who have a chest size of at least 26 inches (66 cm) and a minimum body weight of 41 pounds (20 Kg).
From an announcement by the FDA:
Today’s pediatric approval was based on published studies and a company registery 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.
Product page: ZOLL LifeVest…