FDA APPROVES first automatic heart-starting machine for children
Friday, May 4th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ The first children's automatic external defibrillator, a device which restores normal heartbeat, has been cleared for marketing by the Food and Drug Administration.
The federal agency announced Friday that it was approving the device made by Agilent Technologies Inc. of Palo Alto, Calif.
The device is for use on infants and children up to the age of eight, or up to 55 pounds. Before Friday's clearance, automatic external defibrillators were approved for use only on adults and on children over the age of eight.
A defibrillator is a lifesaving device that delivers an electric shock to an ailing heart through pads placed on the chest. It is used when the heart has developed an irregular or ineffective beat, a condition called fibrillating, a type of cardiac arrest. The external defibrillator delivers a shock through the chest wall to restore the normal heartbeat.
An Agilent defibrillator earlier approved for use on adults and adolescents has been used successfully thousands of times to save lives, the FDA said. The new device for children uses pads that deliver less electric shock.
Standard defibrillators jolt the patient with about 150 joules of energy, while the new children's device, with its pediatric pads, delivers about a third of that.
An FDA statement said the Agilent device was cleared for use on young children after the company performed laboratory and animal tests and after successful tests on children and adults.
The FDA said Agilent will conduct additional studies on 50 children worldwide to evaluate how the device performs in actual use.