PocketCPR Device Receives FDA Clearance as an Over-the-Counter Rescue Device
Named 2007 Hot Product of the Year by the Journal of Emergency Medical Services
PAWTUCKET, R.I.—Bio-Detek, Inc., a wholly-owned subsidiary of ZOLL Medical Corporation and a manufacturer of ECG, pacing, defibrillation and multi-function electrodes, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market and sell PocketCPR™, a palm-sized device that utilizes ZOLL Medical Corporation’s Real CPR Help® technology to assist in the delivery of quality cardiopulmonary resuscitation (CPR) chest compressions.
PocketCPR incorporates ZOLL’s Real CPR Help into a low-cost, battery-powered rescue device. When placed on a cardiac arrest victim, the device provides the same CPR real-time audible messages as provided in the ZOLL AED Plus® and other ZOLL defibrillators. It can say “press harder” or “good compressions” to a rescuer and provides a metronome to help achieve the proper rates supporting American Heart Association 2005 Guidelines. It also provides visual feedback on depth with LED indicators. PocketCPR reminds rescuers to call 911 and to perform other steps in helping a victim.
The AHA Guidelines speak of the “promise for future AEDs that may prompt rescuers to improve the quality of CPR provided”. Real CPR Help in Pocket CPR, AED Plus and other defibrillators directly addresses this promise.
“All of ZOLL’s defibrillators feature Real CPR Help, which enables measurement of the actual rate and depth of chest compressions. However, not everyone who needs CPR coaching will have one of our defibrillators at the time of an emergency, and this new device fills that need, said Richard A. Packer, President and Chief Executive Officer of ZOLL. “Having Real CPR Help available in a standalone product means that more patients can have better CPR delivered immediately following a cardiac arrest, as recommended in the American Heart Association 2005 Guidelines.”.
For the rescuer, the hand-held device provides immediate feedback during a rescue situation. The device accurately guides a person performing CPR to the AHA-recommended 1.5 inches to 2 inches depth and 100 beats per minute rate for chest compressions. Worldwide, sudden cardiac arrest (SCA) claims between 600,000 to 700,000 victims each year. Effective CPR, when delivered quickly after the onset of SCA, can dramatically increase the probability of survival.
Earlier in the year, the Journal of Emergency Medical Services (JEMS) designated PocketCPR as one of the medical device industry’s “2007 Hot Products of the Year” in recognition of its ability to assist CPR trainers in the classroom and to help students practice.
The FDA-cleared version of PocketCPR is expected to be available in the first quarter of 2008. For more information, visitwww.pocketcpr.com or call (401) 729-1400.
About ZOLL Medical Corporation
ZOLL Medical Corporation is committed to developing technologies that help advance the practice of resuscitation. With products for pacing, defibrillation, circulation, ventilation, and fluid resuscitation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims. ZOLL also designs and markets software that automates the documentation and management of both clinical and non-clinical information.
ZOLL markets and sells its products in more than 140 countries. The Company has direct operations, distributor networks, and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East and Africa, Asia, and Australia.
Certain statements contained in this press release regarding matters that are not historical facts are
“forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, ZOLL’s ability to compete in the resuscitation business; acceptance of its recently launched products; changes in regulations affecting the healthcare industry; global economic conditions; and those other factors discussed in the section entitled “Risk Factors” in ZOLL’s Quarterly Report on Form 10-Q, which was filed with the SEC on August 10, 2007.
©2007 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. PocketCPR is a trademark of ZOLL Medical Corporation. ZOLL, AED Plus and Real CPR Help are registered trademarks of ZOLL Medical Corporation. All product names are the property of their respective owners.