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Rectilinear Biphasic Defibrillation Surpasses Key Milestone; Growing Installed Base Yields Superior Clinical Results.


Business/Technology Editors

BURLINGTON, Mass.--(BUSINESS WIRE)--Aug. 2, 2000

ZOLL Medical Corporation (Nasdaq: ZOLL), a manufacturer of non-invasive cardiac resuscitation resuscitation /re·sus·ci·ta·tion/ (-sus?i-ta´shun) restoration to life of one apparently dead.

cardiopulmonary resuscitation
 devices which provide pacing and 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.
, today announced a commercial milestone related to its proprietary Rectilinear rec·ti·lin·e·ar  
adj.
Moving in, consisting of, bounded by, or characterized by a straight line or lines: following a rectilinear path; rectilinear patterns in wallpaper.
 Biphasic bi·pha·sic  
adj.
Having two distinct phases: a biphasic waveform; a biphasic response to a stimulus. 
 defibrillation technology. Rectilinear Biphasic configurations of the highly successful M Series platform have now been adopted by more than 150 U.S. hospitals for use in the cardioversion Cardioversion Definition

Cardioversion refers to the process of restoring the heart's normal rhythm by applying a controlled electric shock to the exterior of the chest.
 of atrial fibrillation atrial fibrillation

Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection.
.

Designed specifically for external defibrillation, ZOLL's patented technology employs a fixed duration, constant current design that eliminates high peak currents and addresses the challenge of patient impedance. Peer-reviewed, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 trials on 349 patients demonstrates that low-energy Rectilinear Biphasic technology is superior to high-energy monophasic defibrillation. Specifically, the U.S. Food and Drug Administration has cleared ZOLL's marketing claims for superiority with atrial fibrillation and high-impedance (difficult-to-defibrillate) ventricular fibrillation ventricular fibrillation

Uncoordinated contraction of the muscle fibres of the heart's ventricles (see arrhythmia). Causes include heart attack, electric shock, anoxia, abnormally high potassium or low calcium in the blood, and digitalis or epinephrine poisoning (
.

Richard A. Packer, President and Chief Executive Officer commented, "We are pleased with the market's rapid acceptance of low-energy Biphasic technology. The technology is being purchased by a broad range of facilities from leading teaching institutions to smaller community-based hospitals. In the short time the Rectilinear Biphasic technology has been on the market we are seeing it fulfill the promise shown in the clinical trials. Physicians are literally seeing the difference."

As an example, Mr. Packer pointed to an independent account presented at the recent 21st meeting of the North American North American

named after North America.


North American blastomycosis
see North American blastomycosis.

North American cattle tick
see boophilusannulatus.
 Society of Pacing and Electrophysiology. Investigators from the Cleveland Clinic Cleveland Clinic (formally known as the Cleveland Clinic Foundation) is a multispecialty academic medical center located in Cleveland, Ohio, USA. Cleveland Clinic was established in 1921 by four physicians for the purpose of providing patient care, research, and medical  reported the ZOLL Rectilinear Biphasic defibrillation waveform to be 100% efficacious for cardioverting atrial fibrillation in a series of 176 patients. Speaking at the Scientific Sessions, Mark J. Niebauer, Ph.D., MD stated: "Cardioversion with the Rectilinear Biphasic waveform reduces the energy threshold for atrial fibrillation and is successful in patients resistant to monophasic cardioversion at 360 joules. When compared to conventional monophasic technology, the Rectilinear Biphasic waveform was found to achieve these results at energy levels 64 percent lower than that for conventional monophasic cardioversion."

To date, the cumulative Cleveland Clinic experience exceeds 500 patients. Dr. Niebauer highlighted a subset of 11 patients who all previously required dual defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a  shocks (720 joules) for successful cardioversion. All were successfully converted with the Rectilinear Biphasic waveform technology at an average shock of 136 joules.

Mr. Packer concluded, "These findings aren't unique. Reports on patients who were successfully cardioverted with the low energy Rectilinear Biphasic technology despite having failed multiple attempts with high-energy are commonplace. Clinicians are seeing the benefits of low energy Biphasic defibrillation and the superiority of ZOLL's technology. We expect an acceleration in the conversion to Biphasic defibrillation."

ZOLL Medical Corporation designs, manufactures and markets an integrated line of proprietary non-invasive resuscitation devices and disposable electrodes. Used by health care professionals to provide both types of cardiac resuscitation - pacing and defibrillation - these products are essential in the emergency treatment of 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.
 victims both inside and outside the hospital. ZOLL also designs and markets software, which automates collection and management of both clinical and non-clinical data for emergency medical service providers.

Certain statements contained in this press release, including statements regarding the anticipated development of the Company's business, the intent, belief or current expectations of the Company, its directors or its officers, primarily with respect to the Company's business model and future operating performance of the Company, including expectations regarding results in future periods, operating performance, contributions to results from new products, our ability to exploit growth opportunities in the EMS data management and pre-hospital market, and other statements contained herein regarding matters that are not historical facts, are "forward-looking" statements (as such term is 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, those factors discussed in the section entitled "Risk Factors" in the Company's Registration Statement on Form S-3 filed on February 22, 2000, as well as uncertainties regarding the market, acceptance and profitability of the Company's new products and the desire or ability of other parties to purchase the Company's products.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 2, 2000
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