FDA Approves LifeVest Wearable Defibrillator for Children

For heart patients who can't have device implanted

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THURSDAY, Dec. 17, 2015 (HealthDay News) -- The LifeVest wearable defibrillator has been approved by the U.S. Food and Drug Administration for children at risk for cardiac arrest who can't have a defibrillator implanted. The device is already approved for adults.

The wearable model weighs less than 2 pounds. It consists of an electrode belt and garment that surround the patient's chest, and a monitor that's worn around the waist. Users must weigh at least 41 pounds and have a chest size of 26 inches or greater, the size of an average 8-year-old, the FDA said.

The wearable device was first approved for adults in 2001, and later models were approved thereafter. The approval for children followed clinical studies of 248 people aged 3 to 17. No additional safety concerns were identified. Four patients who experienced sudden cardiac arrest received a shock that successfully restarted the heart.

"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, M.D., M.P.H., chief medical officer of pediatrics and special populations in the FDA's Center for Devices and Radiological Health, said in a statement. "Doctors now have important information that may help them safely prescribe this life-saving device to young patients."

The device is produced by Pittsburgh-based ZOLL Manufacturing.

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