ZOLL Comments on New AutoPulse Clinical Study Results Presented at the American Heart Association Meeting.CHELMSFORD, Mass. -- ZOLL Medical Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ZOLL), a manufacturer of resuscitation resuscitation /re·sus·ci·ta·tion/ (-sus?i-ta´shun) restoration to life of one apparently dead. cardiopulmonary resuscitation devices and software solutions, commented on three new clinical studies relating to the AutoPulse(R) Non-invasive Cardiac Support Pump that were presented at the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. (AHA) Meeting in Dallas earlier this week. The first presentation, entitled "Effect of a CPR Cardiopulmonary Resuscitation (CPR) Definition Cardiopulmonary resuscitation (CPR) is a procedure to support and maintain breathing and circulation for a person who has stopped breathing (respiratory arrest) and/or whose heart has stopped (cardiac Assist Device on Survival to Emergency Department (ED) Arrival in Out-of-Hospital Cardiac Arrest cardiac arrest n. Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation. Cardiac arrest A condition in which the heart stops functioning. (Mark Swanson, EMT-P EMT-P Paramedic EMT Emergency care An EMT with advanced life support skills–eg, assesses organ systems, inserts IV catheters, administers emergency fluids/medications, noninvasive airway management, uses defibrillators, manages the emotionally disturbed, et al., EVAC EVAC Evacuate/Evacuation/Evacuated EVAC East Valley Astronomy Club (Mesa, AZ) EVAC Emergency Vehicles and Communications (Fargo, ND, USA) EVAC Elmhurst Volunteer Ambulance Corps (Elmhurst, NY) Ambulance, Volusia County, FL)," reported on a concurrently controlled, retrospective review retrospective review, a posttreatment assessment of services on a case-by-case or aggregate basis after the services have been performed. of all pre-hospital patient records for cardiac arrests treated by paramedics between October 2003 and January 2005. The study showed that: --The AutoPulse had a significant improvement in survival to the ED in 118 patients, when compared to manual CPR in 405 patients (29% vs. 19%, p=0.02). --These improvements in survival were most pronounced in patients with initial rhythms of pulseless electrical activity Pulseless Electrical Activity (also known by the older term Electromechanical Dissociation or Non-Perfusing Rhythm) refers to any heart rhythm observed on the electrocardiogram that should be producing a pulse, but is not. (PEA) (32% vs. 17%, p=0.04) and asystole asystole /asys·to·le/ (a-sis´to-le) cardiac standstill or arrest; absence of heartbeat.asystol´ic a·sys·to·le n. The absence of contractions of the heart. (24% vs. 10%, p=0.01). EVAC Ambulance continues to collect and review additional data. A second presentation, entitled "Update on ASPIRE Trial of AutoPulse for Out-of-Hospital Cardiac Arrest (Alfred P. Hallstrom, Ph.D., Seattle, WA; Michael R. Sayre, M.D., Columbus, OH)," reported on interim data from the ASPIRE Trial: --Survival at four hours was similar between 394 patients who received the AutoPulse and 373 patients who received manual CPR (24.7% vs. 26.4%, p=0.62). --Survival to hospital discharge was lower in patients who received AutoPulse versus those who received manual CPR (5.88% vs. 9.9%, p=0.053). This trial was halted based on the difference in survival to hospital discharge between the two groups. The third presentation, entitled "Case-Control Study case-control study, n an investigation employing an epidemiologic approach in which previously existing incidents of a medical condition are used in lieu of gathering new information from a randomized population. of AutoPulse for Out-of-Hospital Cardiac Arrest (Joseph P. Ornato, M.D., Richmond, VA)," reported on a phased, observational evaluation between January 2001 and March 2005 when Richmond Ambulance Authority paramedics switched from manual CPR to CPR using the AutoPulse. The completed study reported the following outcomes among 284 patients who received chest compressions with the AutoPulse, compared to 499 patients who received manual CPR: --There was a significant improvement in the return of spontaneous circulation return of spontaneous circulation Cardiology A palpable pulse which is present after clinically documented asystole. See Atrial fibrillation. (34.5% AutoPulse vs. 20.2% manual CPR, p=0.00001). --There was also a significant improvement in survival to hospital admission (20.9% AutoPulse vs. 11.1% manual CPR, p=0.0002). --Most importantly, improvement in survival to hospital discharge (9.7% AutoPulse vs. 2.9% manual CPR, p=0.0001), was more than double. "The findings of the Richmond and EVAC studies are encouraging because they demonstrate that the AutoPulse has a statistically significant, positive impact on sudden cardiac arrest survival," said Richard A. Packer, ZOLL's President and Chief Executive Officer. "ASPIRE was disappointing not only due to its results, but also because the trial was stopped early and did not achieve statistical significance. The reasons for the ASPIRE results, which were mixed, remain unclear. Such marked difference in the results of these three trials may be due to differences in trial design, use protocols, training, and implementation. Such differences highlight the need for ongoing research in this area to identify the best ways to incorporate automated chest compressions into resuscitation protocols. We will continue our research efforts, and planning is underway on a major new study involving leading resuscitation experts." Mr. Packer concluded, "We believe that continued research will help drive AutoPulse adoption and help to make it a standard of care. We maintain our belief that automated chest-compression devices, such as the AutoPulse, possess great potential for improving CPR performance not only in the field, but also in hospitals. The favorable conclusions of two of the new studies presented at AHA, and five previous studies, add to a strong body of evidence favoring the AutoPulse." About ZOLL Medical Corporation ZOLL Medical Corporation is committed to developing technologies that help advance the practice of resuscitation. With products for pacing, defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. , circulation, ventilation, and fluid resuscitation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS professionals, and lay rescuers resuscitate re·sus·ci·tate v. To restore consciousness, vigor, or life to. 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, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 the AutoPulse; changes in regulations affecting the healthcare industry; general 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 12, 2005. (C) 2005 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. AutoPulse and ZOLL are registered trademarks of ZOLL Medical Corporation. All product names are the property of their respective owners. |
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