Wearable Defibrillator Approved for Children
The FDA has approved the use of the LifeVest wearable defibrillator among children at risk for sudden cardiac arrest who are not eligible for an implantable defibrillator.
The FDA has approved the use of the LifeVest wearable defibrillator among children at risk for sudden cardiac arrest who are not eligible for an implantable defibrillator.
The FDA’s nod for this indication was based on studies involving nearly 250 patients aged 3 to 17. The studies did not find any safety concerns, and 4 of the patients experienced sudden cardiac arrest and received a life-restoring shock from the device.
LifeVest is one of the only products that can, without the need for a second person to operate the defribrillator, monitor a child’s heart continuously for abnormalities and can respond automatically with a shock if necessary.
“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” said Vasum Peiris, chief medical officer of pediatrics and special populations in the FDA’s Center for Devices and Radiological Health, in a press release.
LifeVest weighs less than 2 pounds, and it consists of an electrode belt and garment.
Children who use the device must weigh at least 41 pounds and have a chest size of 26 inches—around the size of the average 8-year-old child.
LifeVest was approved for patients aged 18 and older in 2001.
