USFDA Approves a New Wearable Defibrillator for Children With Cardiac Risk

Children at risk for cardiac arrest and who cannot get a defibrillator implanted in them can now have access to a wearable defibrillator called LifeVest. U.S. Food and Drug Administration has approved this new defibrillator developed by the Pittsburgh-based Zoll Manufacturing.Defibrillators are for people who need to monitor their heart rhythms continuously due to risk for abnormalities. Abnormal heart beats can cause cardiac arrest. Defibrillators are restricted for some children due to certain medical conditions.

LifeVest is light-weight and has an electrode belt and a monitor that can be worn around the waist. It is approved for use in children who weigh less than 41 lb or whose chest size is smaller than 26 in.

"The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients. Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device,” said Dr. Vasum Peiris, chief medical officer of pediatrics and special populations in the FDA's Center for Devices and Radiological Health.

Source-Medindia