Zoll Medical won FDA premarket approval for its LifeVest wearable cardioverter defibrillator designed for children who are at risk for sudden cardiac arrest but aren’t candidates for an implantable defibrillator, according to an FDA release.
The LifeVest is the only wearable cardioverter defibrillator that monitors the heart continuously for abnormal heart arrhythmias and responds automatically, Zoll said.
“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,” FDA CDRH chief medical officer Dr. Vasum Peiris said in a press release.
The wearable device weighs less than 2 pounds and consists of an electrode belt and chest garment and a wrist-worn monitor. The LifeVest is intended for children that weigh at least 41 pounds with chest sizes of 26 inches or greater, which Zoll said is about the size of an average 8 year old.
The device was initially approved in 2001 for adult use, and 3 newer generation models of the device have been approved since.
Pediatric approval was based published studies on the device used to treat 248 patients between the ages of 3 and 17 who were at risk for sudden cardiac arrest. No safety events were identified, and 4 patients received shocks to restore healthy heartbeats, Zoll said.