Zoll Scores Win at FDA

The FDA has given a thumbs up to a new indication for Zoll’s LifeVest wearable cardioverter defibrillator.

The device now may be used for certain children who are at risk for sudden cardiac arrest, but who are not candidates for an implantable defibrillator. According to the FDA, LifeVest is the only defibrillator worn by the patient and monitors the heart for arrhythmias. It responds automatically if it senses the need to deliver a shock to restore a patient’s heartbeat.

Weighing less than two pounds, the device consists of an electrode belt and garment that surround the patient’s chest, as well as a monitor that the patient wears around his or her waist. It is intended only for patients who weigh at least 41 pounds and have a chest size of 26 inches or more.

It was approved in 2001 for patients 18 years of age and older. — Elizabeth Hollis