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FDA: Wearable cardioverter defibrillator approved for children at risk for sudden cardiac arrest
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The FDA has announced approval of a new indication for a wearable cardioverter defibrillator for children who are at risk for sudden cardiac arrest but are not candidates for an implantable defibrillator, according to a press release.
The LifeVest (Zoll) is light, weighing less than 2 lb, and consists of a garment with an electrode belt and a monitor that is worn around the waist. The device is not indicated for children who weigh less than 41 lb or whose chest size is smaller than 26 in, according to the release.
The pediatric approval was based on published studies and a company registry containing clinical information from 248 patients aged 3 to 17 years at risk for sudden cardiac arrest.
The LifeVest was first approved in 2001 for patients aged 18 years 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, MD, MPH, chief medical officer of pediatrics and special populations in the FDA’s Center for Devices and Radiological Health, said in the 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.”
Disclosure: Peiris is an employee in the FDA’s Center for Devices and Radiological Health.