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FDA Approves Wearable Defibrillator for Children at Risk for Sudden Cardiac Arrest

Device weighs less than two pounds

The FDA has approved a new indication for the LifeVest wearable cardioverter defibrillator (Zoll Manufacturing Corporation). The LifeVest is now approved for certain children who are at risk for sudden cardiac arrest but are not candidates for an implantable defibrillator because of certain medical conditions or lack of parental consent. The device was first approved in 2001 for use in adults (18 years of age and older).

While many automated external defibrillators (which require a second person to operate them) have been cleared for use in children, LifeVest is the only one that is worn by the patient and that monitors the heart continuously for arrhythmias. The device responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.

Ventricular fibrillation (V-fib) or ventricular tachycardia (V-tach) is the most common cause of sudden cardiac arrest, according to the National Heart, Lung, and Blood Institute. Diseases and conditions that can lead to sudden cardiac arrest include heart disease, certain inherited disorders, and structural changes in the heart (such as those due to infection or congenital heart disease). Most people who have sudden cardiac arrest will die from it, often within minutes.

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, about the size of an average 8 year old.

The new pediatric approval was based on published studies and a company registry containing clinical information from 248 patients, 3 to 17 years of age, 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.

Source: FDA; December 17, 2015.

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