The FDA has approved a new indication for Zoll’s LifeVest wearable cardioverter defibrillator to include children who are at risk for sudden cardiac arrest. This is limited to those who are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
LifeVest is the only automated external defibrillator for pediatrics that is worn by the patient and monitors continuously for abnormal life-threatening arrhythmias. It responds automatically if it senses the need to deliver a shock. The device weighs less than 2lbs and consists of an electrode belt and garment that surrounds the patient’s chest, and a monitor that the patient wears around their waist.
The FDA approval for pediatric use was based on published studies and a company registry containing clinical data on 248 patients aged 3–17 at risk for sudden cardiac arrest. The data showed no additional safety concerns, while 4 patients who experienced sudden cardiac arrest received a shock that restored a life-sustaining heartbeat.
LifeVest is intended for use in children that weigh ≥41lbs with a chest size ≥26in. In 2001, the device was initially approved for patients aged ≥18 years. Subsequent models of LifeVest were approved for patients aged ≥18 years in 2002, 2006, and 2009.
For more information visit lifevest.zoll.com.