The FDA approved the LifeVest wearable cardioverter defibrillator (Zoll Lifecor Corp.) on Dec. 17 to treat some children who are at risk for sudden cardiac arrest. The device was approved in 2001 for adults who were at least 18 years old.
Patients wear the LifeVest outside of the body and use it to monitor their heartbeat and detect arrythmias. The device weighs less than two pounds and contains an electrode belt that fits within a lightweight garment worn on the patient’s chest and a monitor and alarm that the patient wears around the waist.
If the system detects ventricular tachycardia or ventricular fibrillation, it delivers a high-energy shock. Ventricular tachycardia and ventricular fibrillation are the most common cause of sudden cardiac arrest. The FDA said most people die after suffering from a sudden cardiac arrest, although rapid treatment with a defibrillator can save their lives.
The LifeVest is only approved for children who weigh at least 41 pounds and have a chest size of at least 26 inches.
The approval was based on studies and a Zoll registry that contained information on 248 children between 3 and 17 years old who were at risk for sudden cardiac arrest. The FDA said it did not identify any additional safety concerns. In addition, four patients survived after receiving a shock following sudden cardiac arrest.