ZOLL Medical Receives International Regulatory Approvals for Two Resuscitation Products
ZOLL Medical Corporation announced today it has received international regulatory approvals for two products: the Power Infuser® from ZOLL’s Infusion Dynamics division, and the ZOLL AutoPulse™ Non-invasive Cardiac Support Pump.
(PRWEB) June 17, 2005
ZOLL Medical Corporation (NASDAQ: ZOLL), a manufacturer of resuscitation devices and software solutions, announced today that it has received international regulatory approvals for two products: the Power Infuser® from ZOLL’s Infusion Dynamics division, and the ZOLL AutoPulse™ Non-invasive Cardiac Support Pump.
The Power Infuser has been granted approval by the Canadian Regulatory Agency, Health Canada Therapeutic Products Directorate (HCTPD), to begin marketing in Canada. In addition, the Power Infuser is now labeled with the CE Mark, allowing for the sale of the miniature fluid resuscitation pump in the European Union. To qualify for the CE Mark, the Power Infuser was tested to international standards for electrical safety and electromagnetic compatibility. This testing is in addition to rigorous electromagnetic, climatic, altitude, vibration, and human-factor tests previously conducted by the U. S. Army and U. S. Air Force, which qualified the device for use in military aircraft.
Additionally, the AutoPulse has received approval from AustraliaÂ’s Therapeutic Goods Administration (TGA), allowing for the sale and marketing of the AutoPulse to help treat sudden cardiac arrest in that country. The AutoPulse already has the CE Mark for Europe, as well as regulatory approvals in Canada and New Zealand.
“These additional approvals expand the markets where ZOLL can sell its advanced resuscitation products, and should help to continue the progress made in international sales last quarter,” said Richard A. Packer, President and Chief Executive Officer. “ZOLL remains focused on advancing the practice of resuscitation worldwide by offering a range of products that work together and help healthcare professionals save lives.”
About the ZOLL AutoPulse
The AutoPulse™ Non-invasive Cardiac Support Pump is revolutionary in its design and potential to offer better outcomes. As an adjunct to CPR efforts, the AutoPulse can do chest compressions that humans can’t possibly do, while moving much more blood, more effectively,(1-5) to the heart and brain. The device is comprised of a backboard and a simple LifeBand™ that fastens across a victim’s chest. The AutoPulse compresses the entire chest in a unique, consistent “hands-free” manner, moving more blood than can be moved during manual CPR.(2-4)
About the Power Infuser
ZOLL’s Infusion Dynamics division manufactures and markets the Power Infuser®, a small, lightweight, easy-to-use device, which provides highly controlled, rapid delivery of intravenous (IV) fluids to trauma victims. Using a patented mechanism, the pump delivers controlled fluid boluses at rates up to 100 ml per minute—several times that of conventional infusion pumps. Yet, it is small enough to strap to a patient’s arm.
Primarily sold to the military today, this product has applications in aeromedical transport, EMS, and emergency room settings. Infusion Dynamics and the Walter Reed Army Institute of Research in Silver Spring, Md., jointly conceived the Power Infuser to treat wounded soldiers on the battlefield and in transport.
About ZOLL Medical Corporation
ZOLL Medical Corporation (NASDAQ: ZOLL) 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 can 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 data.
ZOLL has operations in the United States, Canada, the United Kingdom, Germany, France, The Netherlands, Australia, and Austria. With direct operations, international offices, and business partners in all of the worldÂ’s major markets, ZOLL markets and sells its products in more than 140 countries.
Certain statements contained in this press release, including statements regarding the anticipated development of ZOLL’s business, potential sales levels, its ability to differentiate its products from others on the market, and other statements contained herein 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 the ability of the ZOLL sales force to market successfully multiple resuscitation products, and those factors discussed in the section entitled “Risk Factors” in ZOLL’s Quarterly Report on Form 10-Q, which was filed with the SEC on May 13, 2005.
Copyright © 2005 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. AutoPulse and LifeBand are trademarks of ZOLL Medical Corporation. Power Infuser and ZOLL are registered trademarks of ZOLL Medical Corporation. All trademarks are property of their respective owners.
1 Casner M et al. The impact of a new CPR assist device on rate of return of spontaneous circulation in out-of-hospital cardiac arrest. Prehospital Emergency Care. 2005;9:61-67.
2 Timerman S et al. Improved hemodynamic performance with a novel chest compression device during treatment of in-hospital cardiac arrest. Resuscitation. 2004;61:273-280.
3 Halperin HR et al. Improved hemodynamics with a novel chest compression device during a porcine model of cardiac arrest. Circulation. 2002:106(19)(Suppl II):538.
4 Ikeno F et all. Improved survival with a novel chest compression device during a porcine model of cardiac arrest. Circulation. 2003;108(17)(suppl IV):381.
5 Ornato JP et al. Improvement in field return of spontaneous circulation using circumferential chest compression cardiopulmonary resuscitation. Prehospital Emergency Care. 9(1):104.
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