A new indication for the LifeVest wearable cardioverter defibrillator has received the US Food and Drug Administration’s (FDA) approval. The device has been given approval for certain children who are vulnerable to instant cardiac arrest, but are not applicants for an implantable defibrillator because of some medical conditions or lack of approval by parents.
The pediatric has received approval on the basis of published studies and a company registry that includes clinical information from 248 patients, from age group 3 years to 17 years, vulnerable to sudden cardiac arrest.
No extra safety concerns have been found, and 4 patients who suffered sudden cardiac arrest got a shock that restored a life-sustaining heartbeat successfully.
The ZOLL Manufacturing Corp., based in Pittsburgh, Pennsylvania, has manufactured the LifeVest defibrillator. The weight of the device is less than 2 pounds. The device has 2 key components: an electrode belt and garment, surrounding the chest of the patient, and a monitor that is wore around the waist.
This device has been projected only for the children, weighing at least 41 pounds and the ones, who have a chest size of 26 inches or above, nearly the size of an average 8 year old child.
A number of automated external defibrillators that need a second person for operation have been passed for children usage. However, LifeVest is the only one that a patient wears and it monitors the heart constantly for life-threatening, abnormal heart rhythms called arrhythmias.
LifeVest on sensing the need to deliver a shock responds automatically and restores a life-sustaining heartbeat.