Zoll Medical’s LiveVest wearable cardioverter defibrillator has been approved for a new paediatric indication by the US Food and Drug Administration. It is now approved for use by certain children who are at risk for sudden cardiac arrest, but who are not candidates for an implantable defibrillator device due to certain medical conditions, or a lack of parental consent.
This approval makes LifeVest the only automated external defibrillator cleared for paediatric use which is worn by the patient and which monitors the heart continuously for arrhythmia.
“The paediatric medical community is often forced to use adult devices off-label without appropriate labelling or instructions for use in paediatric patients,” says Vasum Peiris, 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.”
Weighing less than two pounds, the device consists of two main components: 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 that weigh at least 41 pounds and have a chest size of 26 inches or more.
The device was first approved in 2001 for patients 18 years of age and older. Later models of the device were approved for patients 18 years of age and older in 2002, 2006 and 2009.
This paediatric approval was based on published studies and a company registry containing clinical information from 248 patients, ages 3 to 17, 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.