Chelmsford, MASS. - ZOLL Medical Corporation (NASDAQ: ZOLL), a manufacturer of non-invasive resuscitation devices and software solutions, today 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.”
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. About half of all victims who suddenly collapse initially require defibrillation. For other victims, however, who may have non-shockable heart rhythms, effective CPR is the critical action for survival.
Clinical studies show that cardiac arrest victims are more likely to survive if they receive early defibrillation or bystander CPR. For every minute that passes after cardiac arrest occurs, the chance of a victim’s survival decreases by 10 percent. It is vital that victims be defibrillated within three minutes of arresting. If a victim is not defibrillated within ten minutes, survival is unlikely.
When an ambulance is called to a school, emergency personnel are more likely to find a child in respiratory arrest than cardiac arrest. Nevertheless, whether the victim is an adult or a child, the ZOLL AED Plus helps treat both conditions—including airway management, breathing, and circulation—through voice prompts and its distinctive graphical interface. These “ABCs” are important steps in taking care of children who are not as susceptible to ventricular fibrillation as adults are. By supporting the Chain of Survival (early access, early CPR, early defibrillation, early advanced care), the ZOLL AED Plus helps lay rescuers assess and treat nearly every sudden cardiac arrest victim, making it the only Full-Rescue AED available today.
About ZOLL Medical Corporation
ZOLL Medical Corporation (NASDAQ: ZOLL) designs, manufactures, markets, or sells non-invasive resuscitation devices and software solutions. They include pacing and defibrillation devices (ZOLL’s M Series™ and AED Plus™, and LIFECOR, Inc.’s LifeVest™ Wearable Defibrillator); circulatory assist devices (Advanced Circulatory Systems, Inc.’s ResQPOD™ Circulatory Enhancer and Revivant Corporation’s AutoPulse™); and a fluid resuscitation product called the Power Infuser®, manufactured by Infusion Dynamics, a division of ZOLL. These devices help healthcare professionals, emergency medical service providers, and first responders diagnose and treat victims of trauma, as well as sudden cardiac arrest.
Additionally, through its subsidiary ZOLL Data Systems, ZOLL designs and markets software that automates the collection and management of both clinical and non-clinical data. With direct operations, international offices, and business partners in all of the world’s major markets, ZOLL markets and sells its products in more than 140 countries. For more information, visit www.zoll.com or call (978) 421-9655.