Cardiac Science Inc announced that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance to market its Powerheart AED for use on children under eight years old.
The FDA action clears the way for Cardiac Science to begin marketing its pediatric defibrillation electrode pad system specifically designed to optimize the Powerheart AED for use with small children. Defibrillator electrodes are the pads that are attached to a patient's chest in the event of a cardiac arrest and enable the device to accurately sense patient heart rhythms and when necessary, deliver the electrical energy needed to reverse the life-threatening condition and restore normal heart rhythm. The pediatric electrode pads are significantly smaller than the standard pads to better fit the bodies of young children and have a built-in attenuating mechanism that decreases the energy delivered in the defibrillation shock as smaller victims generally require less energy to be revived from sudden cardiac arrest.
Cardiac Science President and CEO Raymond W. Cohen said, "The school market is expanding rapidly in both the U.S. and U.K. and we anticipate additional legislation, similar to New York State, which will continue to drive adoption of AEDs in schools. As a result this has become a very important segment for Cardiac Science, a segment in which we are clearly the market leader. We believe that FDA clearance of our new pediatric electrode system, specifically designed and validated for use on smaller patients, will help us to maintain our leadership position in that segment.We will immediately begin to ship these electrode systems, which sell for about $90, to all types of customers who are anxious to deploy the new electrode pads in areas where small children are at risk."
Medical health experts have documented a surprising rise in death from sudden cardiac arrest in young adults. A recent study conducted by the Centers for Disease Control and Prevention (CDC) showed a total of 23,320 children and young adults died of cardiac arrest between 1989 and 1996.
In June 2002, the New York State Legislature passed legislation that requires public school facilities to retain an AED on the premises.The enacted law applies to all schools regardless of the size and took effect in December 2002.
According to the National Center for Early Defibrillation, a not-for-profit information resource center based at the University of Pittsburgh (www.early-defib.org), legislation related to the placement and/or funding for AEDs in schools has been passed or is currently under review in at least six states the U.S., including New York, Pennsylvania, Illinois, Massachusetts, New Jersey, and Rhode Island.