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AED Plus Granted 510(k) FDA Clearance

Manufacturing Group | February 14, 2013

Approval marks the first time Real CPR Help from ZOLL Medical Corp. is available to rescuers who prefer a fully automatic AED.

AED Plus Granted 510(k) FDA Clearance

Officials from ZOLL Medical Corp. announce that the company has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin U.S. distribution of the new fully automatic version of the ZOLL AED Plus.

This marks the first time Real CPR Help, ZOLL’s proprietary feedback technology, is available to rescuers who prefer a fully automatic AED. Until now, there was no fully automatic AED in the U.S. market that could see chest compressions and guide rescuers to the proper depth and rate of chest compressions. This feedback technology helps rescuers provide high-quality manual CPR with real-time audible and visual feedback to help them achieve the proper depth and rate of CPR chest compressions.

The new fully automatic unit provides all the same Full-Rescue features and benefits as the semiautomatic version of the AED Plus except that a shock is delivered automatically if one is advised. Shortly after determining that a shock is needed and warning rescuers to stay clear, the Fully Automatic AED Plus delivers the shock automatically – without requiring the rescuer push the Shock button.

Research shows that safety is not compromised when rescuers use a fully automatic rather than a semiautomatic AED.1 On initial power-up, the Fully Automatic AED Plus will prompt “Automatic Defibrillator” to alert the user to the type of AED. Once the heart analysis begins and the Fully Automatic AED Plus prompts “Don’t Touch Patent,” if a shock is needed, it will be delivered after a brief verbal countdown. Typically a shock is delivered within 14 seconds of initial analysis, if the presenting rhythm is shockable.

“Like the semiautomatic AED Plus, the fully automatic version guides rescuers through the complete Chain of Survival, helping all sudden cardiac arrest victims, not just those who need a shock,” states Jonathan A. Rennert, president, ZOLL. “ZOLL’s Real CPR Help has been demonstrated to effectively help guide rescuers to the correct depth and rate of chest compressions with the goal of improving survival from sudden cardiac arrests.”2

About Sudden Cardiac Arrest
SCA, an abrupt disruption of the heart’s function, which causes a lack of blood flow to vital organs, claims more than one million lives globally each year. It is the leading cause of unexpected death in the world and strikes without warning. Survival is poor in most communities at less than eight percent and improvements in resuscitation practices could save as many as half of these victims.

1Hosmans, et al. Resuscitation. 2008 May; 77(2)216-19

2Peberdy MA, et al. Effect of caregiver gender, age, and feedback prompts on chest compression rate and depth. Resuscitation (2009), doi:10.1016/j.resuscitation.2009.07.003

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