The FDA approved a LifeVest wearable cardioverter defibrillator for certain children during risk for remarkable cardiac detain though not means to get an implantable defibrillator due to medical contraindications or miss of parental consent.
The device, that consists of an electrode belt and vest as good as a cardiac stroke guard around a waist, is “intended usually for children that import during slightest 41 pounds and have a chest distance of 26 inches or more, about a distance of an normal 8 year old,” a FDA said.
LifeVest was initial authorized for adult use in 2001. The pediatric capitulation stemmed from clinical studies and a association registry on 248 patients ages 3 to 17 who were during risk for remarkable cardiac arrest, among whom 4 went into remarkable cardiac detain and were successfully repelled behind into stroke by a device.
The FDA proclamation remarkable no additional reserve concerns.
last updated 12.18.2015
Article source: http://www.medpagetoday.com/Cardiology/Arrhythmias/55310