(RxWiki News) An automatic, wearable defibrillator approved for use in adults just got a new approved use: helping kids at risk of sudden cardiac arrest.
The US Food and Drug Administration (FDA) today approved the LifeVest wearable cardioverter defibrillator for use in kids. The device was already cleared for use in adults, and it is now the only wearable, automatic defibrillator approved for use in kids.
“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” said Vasum Peiris, MD, MPH, chief medical officer of pediatrics and special populations in the FDA’s Center for Devices and Radiological Health, in a press release. “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 weighs under 2 pounds and continuously monitors children at risk of sudden cardiac arrest. At-risk children include those with abnormal heart rhythms and inherited heart disorders. Sudden cardiac arrest is often deadly. Defibrillators send a shock to the heart in an attempt to make it start beating again. These devices can be lifesaving, according to the FDA.
The LifeVest monitors patients' heart rhythms and automatically delivers a shock when the heart stops.
The FDA approved the device, which is manufactured by ZOLL Manufacturing Corporation, based on existing studies and ZOLL data on 248 patients ages 3 to 17. The FDA identified no added safety concerns tied to the LifeVest.