ZOLL Receives FDA Premarket Approval for AED With Enhanced Real CPR Help

ZOLL Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, said the ZOLL AED 3 defibrillator received premarket approval (PMA) by the U.S. Food and Drug Administration for use by lay rescuers.
 
“ZOLL is committed to supporting the public with all emergency preparedness needs during this COVID-19 pandemic and every day,” said Elijah A. White, president of ZOLL Resuscitation. “This next generation AED enhances ZOLL’s portfolio of top-of-the-line defibrillators by continuing to deliver real-time CPR feedback and providing even better support for our public access and professional customers. At ZOLL, our mission is to provide intuitive and intelligent AEDs in every public space around the world and to enable bystanders to act quickly, appropriately, and with confidence in sudden cardiac arrest emergencies.” 
 
ZOLL AED 3 continues ZOLL’s tradition of providing AEDs to help improve outcomes from sudden cardiac arrest (SCA) by removing the guesswork for bystanders and giving them the confidence to respond.
 
High-quality CPR is the primary component in influencing survival from cardiac arrest.¹ While only 50 percent of SCA victims will initially need a shock, nearly all will require CPR to increase the flow of blood to the heart and brain. The enhanced Real CPR Help on the ZOLL AED 3 defibrillator provides unexpected heroes the confidence and knowledge needed to provide high-quality CPR when it matters most.
 
ZOLL AED 3 uses proven Real CPR Help technology with integrated, real-time feedback to help deliver Guideline-compliant CPR. Enhanced Real CPR Help offers industry-firsts such as a full-color display with vivid rescue images, a CPR cycle timer, and a large, color bar gauge that shows CPR compression depth. A calm voice tells rescuers to pause when it completes a heart analysis and alerts them if a shock is needed or if CPR should be resumed.
 
“The latest guidelines from resuscitation councils worldwide are clear: Successful defibrillation must be supported by high-quality CPR,” White said. “Every design choice in the ZOLL AED 3 had user confidence and high-quality CPR in mind.”
 
The ZOLL AED 3 defibrillator can treat adult and pediatric patients with a single CPR Uni-padz electrode. To treat a child, rescuers use the same set of pads and simply activate child mode. ZOLL’s introduction of the world’s first 5-year universal CPR electrode not only provides enhanced ease of use, but it further improves the total cost of ownership by eliminating the need to purchase separate electrode pads for adults and children.
 
“This device sets a new industry standard, especially where high-quality CPR and the treatment of young people are concerned,” White explained.
 
Cloud connectivity enables automatic reporting of device status, giving rescuers the confidence of knowing the AED is ready in an emergency. WiFi also provides the ability to quickly access and transmit cardiac arrest event data to medical professionals.
 
SCA is an abrupt disruption of the heart’s function, which causes a lack of blood flow to vital organs. It is the leading cause of unexpected death in the world and strikes without warning.

Reference
¹ Meaney PA, et al. Circulation. 2013 Jul 23;128(4):417–35.