CHELMSFORD, Mass.--(BUSINESS WIRE)--June 13, 2006--ZOLL Medical Corporation (NASDAQ: ZOLL - News), a manufacturer of resuscitation devices and software solutions, today commented on the publication of two studies--known as the “ASPIRE Trial” and the “Richmond Study"--that relate to the AutoPulse® Non-invasive Cardiac Support Pump. The results of these two studies were first presented during the Resuscitation Science Symposium (ReSS) at the November 2005 meeting of the American Heart Association in Dallas. ReSS holds formal discussions and forums about advances in treating cardiac arrest.
The two studies appear in the June 14, 2006 issue of The Journal of the American Medical Association (JAMA). The first study, the ASPIRE Trial, entitled “Manual Chest Compression vs. Use of an Automated Chest Compression Device During Resuscitation Following Out-of-Hospital Cardiac Arrest (Alfred P. Hallstrom, Ph.D., University of Washington, Seattle, WA, et al.),” reported on interim data:
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 (5.8% vs. 9.9%, p=0.06).
Based on this interim data, the trial was halted due to the difference in survival to hospital discharge between the two groups.
The second study, the Richmond Study, entitled “Use of an Automated, Load-Distributing Band (LDB) Chest Compression Device for Out-of-Hospital Cardiac Arrest Resuscitation (Marcus Eng Hock Ong, MD, MPH; Joseph P. Ornato, M.D., Virginia Commonwealth University, Richmond, VA; et al.),” reported on the Richmond Ambulance Authority’s use of the AutoPulse, an LDB device, when compared to manual CPR efforts prior to implementing the AutoPulse:
There was a statistically significant improvement in the return of spontaneous circulation (AutoPulse 34.5% vs. manual CPR 20.2%, adjusted odds ratio (OR) = 1.94, 95% confidence interval (CI) = 1.38-2.72).
There was also a statistically significant improvement in survival to hospital admission (AutoPulse 20.9% vs. manual CPR 11.1%, adjusted OR = 1.88, 95% CI = 1.23-2.86).
Improvement in survival to hospital discharge was more than double (AutoPulse 9.7% vs. manual 2.9%, adjusted OR = 2.27, 95% CI= 1.11-4.77).
“The unexpected ASPIRE Trial results coupled with the strong positive Richmond Study results continue to confound many clinicians in the resuscitation industry,” said Richard A. Packer, ZOLL’s President and Chief Executive Officer. “The ASPIRE Trial findings are disappointing not only due to the results, but also because the trial was stopped early and did not achieve statistical significance. We believe that we have some understanding of the differing results among the ASPIRE sites, protocols, and training issues. Yet, the fundamental reasons for these differences remain unclear. However, we continue to be encouraged by the Richmond Study findings, which demonstrate that the AutoPulse can have a positive impact on cardiac arrest survival.”
Mr. Packer stated, “These differences highlight the complexity of out-of-hospital cardiac arrest resuscitation. There is a need for continued research to identify the best ways to incorporate automated chest compressions into pre-hospital resuscitation protocols. To that end, we hope to initiate a new randomized multi-center clinical study before the end of the year that will help us learn from the issues highlighted by the ASPIRE Trial. Lars Wik, M.D., Ph.D., of the Ulleval University Hospital in Norway, will lead another study that will include sites in the U.S. and Europe. Dr. Wik has conducted and published the results of a number of studies in the area of CPR in the pre-hospital setting. We believe continued research is necessary to show the benefits of the AutoPulse over time.”
Mr. Packer concluded, “We maintain our belief that the AutoPulse has great potential for improving CPR performance in out-of-hospital and in-hospital settings. The favorable findings of the Richmond Study and five other previous studies create a strong body of evidence that supports the device. Furthermore, customers are realizing that beyond clinical matters, rescuer safety and labor efficiency during resuscitation events are additional benefits the AutoPulse can provide. These two studies remind us of how much work there is to do to fully understand and optimize new resuscitation technologies, such as the AutoPulse. More than 400,000 lives are lost each year to out-of-hospital cardiac arrest. Current treatments and interventions have not significantly increased the survival rate from cardiac arrest, which is less than 5%. Given the need for improved treatments and interventions, ZOLL remains committed to delivering technologies that can help rescuers increase cardiac arrest survival.”
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, Asia, and Australia. For more information, visit www.zoll.com or call +1 (978) 421-9655.
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 the AutoPulse and 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 Annual Report on Form 10-Q, which was filed with the SEC on May 12, 2006.
©2006 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.
Contact: Investor Contact: ZOLL Medical Corporation A. Ernest Whiton, +1 978-421-9655 Chief Financial Officer or
Media Contact: ZOLL Medical Corporation Robert Minicucci, +1 978-421-9832 Corporate Communications Manager rminicucci@zoll.com
Source: ZOLL Medical Corporation
