FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
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The U.S. Food and Drug Administration approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardic arrest, but are not candidates for an implantble defibrillator due to certain medical conditions or lack of parental consent.
While manyautomated external defibrillators (which require a second person to operate them) have been cleared for use in children, LifeVest is the only one worn by the patient and monitors the heart continuously for abnormal, life-threatening heart rhythms(arrhythmias) . LifeVest responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.
“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” saidVasum Peiris, M.D., M.P.H., Chief Medical Officer of Pediatrics and Special Populations in the FDA’s Center for Devices and Radiological Health. “Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”
While manyautomated external defibrillators (which require a second person to operate them) have been cleared for use in children, LifeVest is the only one worn by the patient and monitors the heart continuously for abnormal, life-threatening heart rhythms(arrhythmias) . LifeVest responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.
“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” saidVasum Peiris, M.D., M.P.H., Chief Medical Officer of Pediatrics and Special Populations in the FDA’s Center for Devices and Radiological Health. “Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”
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