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July 21, 2004
FOR: ZOLL Medical Corporation
INVESTOR CONTACT: A. Ernest Whiton
Chief Financial Officer
ZOLL Medical Corporation
PRESS CONTACT: Robert Minicucci
Corporate Communications Manager
ZOLL Medical Corporation
+1 (978) 421-9832
FOR IMMEDIATE RELEASE
ZOLL MEDICAL ANNOUNCES FDA MARKETING CLEARANCE FOR LIFECOR IN-HOSPITAL PRODUCT
Wednesday, July 21, 2004 – CHELMSFORD, MASS.—ZOLL Medical Corporation (NASDAQ: ZOLL), a manufacturer of resuscitation devices and software solutions, announced today that the U.S. Food and Drug Administration has granted marketing clearance for LIFECOR’s Life-Padz™ WCD 3000S System, a next-generation wearable cardioverter defibrillator. With this clearance, obtained through a premarket approval application (PMA), ZOLL can begin to market and distribute this product to hospitals in the U.S. This device is indicated for adult patients who are at risk for sudden cardiac arrest.
“The Life-Padz WCD 3000S allows patients, who are at high risk of ventricular fibrillation, to be constantly monitored and receive an immediate, fully automatic defibrillating shock, if needed,” said Richard A. Packer, President and Chief Executive Officer of ZOLL. “While fully automated defibrillation technology has existed in larger bedside devices, the Life-Padz System provides patients with unhindered mobility, and clinicians with the assurance of high-quality care, regardless of the patient’s location or need to ambulate. Additionally, the Life-Padz System offers a potential savings to hospitals by moving at-risk patients from high-cost critical-care beds to lower-cost care units, while maintaining the fastest response to a potentially life-threatening arrhythmia.”
Data from the National Registry of Cardiopulmonary Resuscitation (NRCPR), which includes information on more than 14,000 adult in-hospital cardiac arrests, suggests that survival is improved when the first defibrillating shock is delivered within three minutes. The Life-Padz WCD 3000S offers an opportunity to improve the time to first shock, regardless of the patient’s location.
The Life-Padz WCD 3000S consists of a wearable monitor, a 3-lead electrocardiogram (ECG) system, and one set of therapy pads that are applied on the patient’s chest and back. The device continuously monitors a patient's heart through the ECG electrodes, documenting critical events. If a life-threatening rhythm is detected, the device automatically delivers an electrical shock to restore a normal heart rhythm.
In April 2004, ZOLL announced an exclusive license agreement, under which ZOLL acquired all marketing and distribution rights to LIFECOR’s technology for in-hospital use. LIFECOR is obligated to produce product for ZOLL, and ZOLL will continue to use the LIFECOR and LifeVest brands in the hospital market.
About ZOLL Medical Corporation
ZOLL Medical Corporation (NASDAQ: ZOLL) designs, manufactures, markets, and/or sells non-invasive resuscitation devices and software solutions. They include pacing and defibrillation devices (ZOLL’s M Series™ and AED Plus™, and LIFECOR, Inc.’s LifeVest™ Wearable Defibrillator), circulatory assist devices (Advanced Circulatory Systems, Inc.’s ResQPOD™ Circulatory Enhancer and Revivant Corporation’s AutoPulse™); and a fluid resuscitation product called the Power Infuser®, manufactured by Infusion Dynamics, a division of ZOLL. These devices help healthcare professionals, emergency medical service providers, and first responders diagnose and treat victims of trauma, as well as sudden cardiac arrest.
Additionally, through its subsidiary ZOLL Data Systems, ZOLL designs and markets software that automates the collection and management of both clinical and non-clinical data. With direct operations, international offices, and business partners in all of the world’s major markets, ZOLL markets and sells its products in more than 140 countries. For more information, visit www.zoll.com or call +1 (978) 421-9655.
Certain statements contained in this press release, including statements regarding the anticipated development of the Company’s business, our ability to differentiate our 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, those factors discussed in the section entitled "Risk Factors" in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 19, 2004.
Copyright © 2004 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. AED Plus, Life-Padz, M Series, and Power Infuser are trademarks of ZOLL Medical Corporation. The LifeVest System is a trademark of LIFECOR, Inc. The ResQPOD is a trademark of Advanced Circulatory Systems, Inc. The AutoPulse Resuscitation System is a trademark of Revivant Corporation. ZOLL is a registered trademark of ZOLL Medical Corporation. All trademarks are property of their respective owners.
© Copyright ZOLL Medical Corporation. All rights reserved.