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FDA issues marketing clearance for AED Plus pediatric capability.
2004 JUL 1 - (NewsRx.com & NewsRx.net) -- ZOLL Medical Corporation (ZOLL) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance for the new pediatric capability in ZOLL's automated external defibrillator, the AED Plus.
This capability, for children up to 8 years of age, is now available to customers and distributors in the U.S. and worldwide.
The new pediatric capability includes voice prompts that tell rescuers what type of electrodes--adult or pediatric--are connected, so that the proper electrodes are used. Separate and specific algorithms for adults and children are used to analyze a victim's heart rhythm.
Pediatric-specific energy levels also have been incorporated. Electronics in the AED Plus adjust defibrillating energy levels automatically so that suitable doses, when needed, are delivered.
"This pediatric capability allows the AED Plus to help rescuers treat pediatric or adult victims of sudden cardiac arrest wherever it occurs," said Richard A. Packer, president and chief executive officer of ZOLL.
"This capability allows us to approach more than 14,500 U.S public school districts and more than 27,000 private schools. Additionally, it provides ZOLL with an opportunity to educate additional rescuers about the importance of early defibrillation and early CPR (cardiopulmonary resuscitation)."
When a victim collapses from sudden cardiac arrest, rescuers do not know whether defibrillation or CPR is the appropriate therapy until an AED is attached and the victim's heart is analyzed.
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