FDA Clears Zoll’s First Fully Automatic Defibrillator

In short

Massachussetts-based medical device company Zoll Medical Corporation has received FDA 510(k) clearance for its new fully automatic version of the Zoll AED Plus® external defibrillator. This is the first time Real CPR Help®, Zoll’s proprietary feedback technology, has been made available in a fully automatic Automated External Defibrillator (AED).

Background 

Sudden Cardiac Arrest 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.

Zoll Medical Corporation specialises in developing products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management.  This comprehensive set of technologies helps clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and critical care.

Zoll’s newly-cleared device is the first in the U.S. to provide high-quality manual CPR with real-time audible and visual feedback to help rescuers 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 semi-automatic version of the AED Plus except for one principal feature: 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 has reportedly shown that that safety is not compromised when rescuers use a fully automatic rather than a semi-automatic AED and of course the benefit of delivering timely and of appropriate therapy could prove critical.

Company comments 

“Like the semi-automatic 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,” said Jonathan A. Rennert, President of 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.”

Source: Zoll Medical Corporation