LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess their long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their common activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
U.S. Food and Drug Administration has approved the new indication LifeVest wearable cardioverter defibrillator.
The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk.
LifeVest is the only one worn by the patient and monitors the heart continuously for abnormal, life-threatening heart rhythms (arrhythmias). LifeVest responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.
“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” said Vasum Peiris, M.D., M.P.H., Chief Medical Officer of Pediatrics and Special Populations in the FDA’s Center for Devices and Radiological Health. “Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”
A life-threatening abnormal heart rhythm, referred to as 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. Certain 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. Rapid treatment with a defibrillator can save lives.
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.
http://lifevest.zoll.com/