FDA Approves Wearable Defibrillator for Kids
Yesterday FDA announced the approval of a wearable cardioverter defibrillator for children. Made by Zoll Manufacturing Corp., the LifeVest has been on the market since 2001, when it was approved for patients 18 years and older. According to the FDA, the device is intended for children who are at risk for sudden cardiac arrest but are not candidates for an implantable defibrillator (this can be as a result of a medical condition or lack of a parent consenting).
The lightweight device monitors and treats arrhythmias with the delivery of a high-energy shock to set the heart back to a normal rhythm. The vest is worn outside of the body.
“Today’s pediatric 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,” according to an FDA release. “No additional safety concerns were identified, and four patients who experienced sudden cardiac arrest received a shock that successfully restored a life-sustaining heartbeat.”
- Weight: 2 lbs
- Components: Electrode belt and garment worn on the patient’s chest; monitor worn around the waist
- Intended patient: Children must weigh at least 41 lbs and have a chest size of 26 in. or more. The agency notes this is about the average size of an eight year old
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