Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and Drug Administration

  Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and
  Drug Administration

             Real CPR Help Now Available in a Fully Automatic AED

Business Wire

CHELMSFORD, Mass. -- February 7, 2013

ZOLL Medical Corporation, a manufacturer of medical devices and related
software solutions, announced today that it 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,” 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.”^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.

About ZOLL Medical Corporation

ZOLL Medical Corporation, an Asahi Kasei Group company, develops and markets
medical devices and software solutions that help advance emergency care and
save lives, while increasing clinical and operational efficiencies. With
products for defibrillation and monitoring, circulation and CPR feedback, data
management, fluid resuscitation, and therapeutic temperature management, ZOLL
provides a comprehensive set of technologies that help clinicians, EMS and
fire professionals, and lay rescuers treat victims needing resuscitation and
critical care. For more information, visit www.zoll.com.

About Asahi Kasei

The Asahi Kasei Group is a diversified group of companies led by holding
company Asahi Kasei Corp., with operations in the chemicals and fibers, homes
and construction materials, electronics, and health care business sectors. Its
health care operations include devices and systems for critical care,
dialysis, therapeutic apheresis, transfusion, and manufacture of
biotherapeutics, as well as pharmaceuticals, diagnostic reagents, and
nutritional products. With more than 25,000 employees around the world, the
Asahi Kasei Group serves customers in more than 100 countries. For more
information, visit www.asahi-kasei.co.jp/asahi/en/.

^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

Copyright © 2013 ZOLL Medical Corporation. All rights reserved. AED Plus, Real
CPR Help and ZOLL are trademarks or registered trademarks of ZOLL Medical
Corporation in the United States and/or other countries. Asahi Kasei is a
registered trademark of Asahi Kasei Corporation. All trademarks are the
property of their respective owners.

Contact:

ZOLL Medical Corporation
Diane Egan, +1-978-421-9637
degan@zoll.com
 
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