|LifeVest cardioverter defibrillator--Courtesy of Zoll Medical|
Doctors have long lamented being forced to use devices on pediatric patients off-label, putting them at greater risk of a medical malpractice lawsuit in the event that something goes wrong.
The FDA took a step toward fixing the problem by clearing Zoll Medical's wearable cardioverter defibrillator to treat sudden cardiac arrest in children who are not candidates for an implantable defibrillator due to medical conditions or lack of parental consent.
In addition, the FDA said the device is intended for children who weigh at least 41 pounds and have a chest size of 26 inches or more, which is around the size of the average 8-year-old.
The expanded indication was based on published studies and company registry data containing information about 248 patients aged 3 to 17 who are at risk for sudden cardiac arrest, the FDA said.
"The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients," said Dr. Vasum Peiris, the chief medical officer of pediatrics and special populations at the FDA's device arm (CRDH). "Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device."
The LifeVest is the only wearable defibrillator that continuously monitors the heart for arrhythmias, setting it apart from other automatic external defibrillators (AEDS), which require first responders to operate them following sudden cardiac arrest.
"When the device detects an abnormal heart rhythm, an alarm sequence begins, giving a patient time to stop the treatment if it is not necessary. The patient can prevent a shock by simultaneously pressing two response buttons. If the patient does not respond to the alarm or releases the response buttons, the device continues to alarm and gives a verbal warning that a treatment shock is about to be delivered. Just before a shock is delivered, blue gel within the electrodes is released so the shock will be given efficiently," the FDA explains on its website.
And the agency points out that most people who suffer from sudden cardiac arrest die within minutes, unless they are quickly resuscitated by a defibrillator.
Weighing less than two pounds, Zoll's LifeVest consists of an electrode belt and garment that wrap around a patient's chest, and a monitor worn around the waist.
The device was approved for adults in 2001, with upgrades permitted in 2002, 2006 and 2009, the FDA says. It does not appear that the device had to be modified in any way in order to be approved for use in children.
In addition, Pittsburgh-based Zoll recently launched the first and only CPR device approved by the FDA to improve the chances of surviving cardiac arrest among adults experiencing nontraumatic sudden cardiac arrest.
In September, the company amplified its focus on heart failure with the acquisition of Israel's Kyma Medical Technologies for $35 million, plus milestone payments. Kyma makes a wearable remote patient monitoring device for congestive heart failure.
- read the release from the FDA
- here's more information the FDA