FDA Okays Defibrillator System for Pediatric Use

WASHINGTON (Reuters Health) Jan 28 – Cardiac Science Inc. said on Tuesday that it has received a supplemental clearance from the US Food and Drug Administration (FDA) to market its pediatric defibrillation electrode pad system for its Powerheart AED (automatic emergency defibrillator), permitting the system to be used on children under eight years old.

The pediatric electrode pads are significantly smaller than the standard pads, to better fit the bodies of children. The pediatric system also is designed to decrease the energy delivered during a defibrillation shock.

“The school market is expanding rapidly in both the US and UK and we anticipate additional legislation, similar to New York State, which will continue to drive adoption of automatic external defibrillators in schools,” said Cardiac Science CEO Raymond W. Cohen.

Cohen added that the new pad system would retail for about $90 and that shipments would begin immediately.

Citing a study conducted by the Centers for Disease Control and Prevention (CDC), the medical device maker estimated that about 23,320 children and young adults in the US died of cardiac arrest between 1989 and 1996.