FDA Clears LifeVest Wearable Defibrillator for Pediatric Use

Megan Brooks

Disclosures

December 17, 2015

The US Food and Drug Administration (FDA) has approved the LifeVest wearable cardioverter defibrillator (Zoll Manufacturing Corporation) for pediatric use.

"The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent," the FDA said in a statement.

Worn by the patient, LifeVest continuously monitors the heart for arrhythmia and responds automatically if it senses the need to deliver a shock, restoring normal heart rhythm.

The LifeVest weighs less than 2 pounds and consists of an electrode belt and garment that surround the patient's chest and a monitor that the patient wears around his or her waist. This device is intended only for children who weigh at least 41 pounds and have a chest size of 26 inches or more, about the size of an average 8-year-old.

"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 statement. "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 LifeVest was first approved in 2001 for patients aged 18 years and older.

The FDA's approval of LifeVest for use in children 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.

"No additional safety concerns were identified, and four patients who experienced sudden cardiac arrest received a shock that successfully restored a life-sustaining heartbeat," the FDA said.

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