FDA approves LifeVest defibrillator for children
The LifeVest, which is manufactured by ZOLL Manufacturing Corp., consists of a wearable automated external defibrillator and a sensor that continuously monitors the heart to detect abnormal heart rhythms.
The device is now approved for use with children that weigh at least 41 pounds with a chest size of 26 inches. The vest weighs less than two pounds. If abnormal heart rhythms that lead to sudden cardiac arrest are detected, the vest provides a shock to restore a normal heartbeat.
“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.”
The FDA's approval was based on studies and company information regarding 248 pediatric patients ranging in age from three to 17. Four patients experienced sudden cardiac arrest -- and the LifeVest restored their heartbeat. No safety concerns were identified in the published studies of the device.
Organizations in this story
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD - 20903