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Cambridge Heart Introduces New Electrophysiology Product At NASPE Conference; Thirteen Independent Studies of T-Wave Alternans to be Presented At Conference.


Business/Technology Editors & Health/Medical Writers

BEDFORD, Mass.--(BW HealthWire)--May 17, 2000

Cambridge Heart, Inc. (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
: CAMH CAMH Centre for Addiction and Mental Health
CAMH Contemporary Arts Museum Houston (Houston, TX)
CAMH Comprehensive Accreditation Manual for Hospitals
) today announced the introduction of the HearTwave EP(TM) at the 21st Annual 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 (NASPE NASPE National Association for Sport and Physical Education
NASPE North American Society of Pacing and Electrophysiology
NASPE National Association of State Personnel Executives
) being held this week in Washington, DC. The HearTwave EP(TM) measures Microvolt microvolt

one-millionth (10-6) of a volt; abbreviated µV.
 T-wave alternans T-wave alternans Cardiology A subtle every-other-beat variation in T waves that is prognostic of Pts at high risk for life-threatening cardiac arrhythmias and sudden cardiac death. See Alternans test.  in patients undergoing ventricular electrophysiology (EP) testing. It connects between the existing EP laboratory system and the patient and makes the Microvolt T-wave Alternans measurement using Cambridge Heart's proprietary Alternans Sensors. Ventricular EP testing is an invasive procedure that uses pacing catheters to stimulate the ventricles Ventricles
The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues.
 of the heart; it is the gold standard test for risk of sudden death. There are approximately 1,000 EP labs in the U.S which conduct approximately 100,000 ventricular EP studies per year.

The HearTwave EP(TM) is pending 510k clearance from the U.S. Food and Drug Administration ("FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
"). Clearance and initial product shipments are anticipated to occur during the third quarter of 2000. Prior to FDA clearance, the Company may not make claims about the product's safety and effectiveness nor accept customer orders.

"Recent data from the MUSTT trial and elsewhere has given electrophysiologists (EP's) concern about the predictive accuracy of EP testing in many situations. The Microvolt Alternans Test provides the EP important additional data in more difficult cases and in those disease states where EP testing is less predictive." said Jeffrey M. Arnold, Cambridge Heart President, Chairman, and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Some physicians are making this measurement currently on all of their EP patients with our CH 2000 System. The HearTwave EP(TM) provides a lower cost alternative for the EP lab where full stress test capability is not required. We expect that a significant number of EP's will adopt the technology and that, because of the relatively high reimbursement for EP study compared to stress test, the usage of the alternans test by EP's will be less dependent on a need for reimbursement in the short term."

The Company also announced that the results of thirteen independent studies of T-wave alternans will be presented at this weeks NASPE meeting . The presentations will include the results of a variety of new and confirming studies. Included in them is an independent study by Dr. Karen McMurdy of the University of Maryland University of Maryland can refer to:
  • University of Maryland, College Park, a research-extensive and flagship university; when the term "University of Maryland" is used without any qualification, it generally refers to this school
 that supports and confirms the results of Cambridge Heart's multicenter study performed for FDA labeling. In this independent study of 146 patients with coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue.  referred for EP study, T-wave alternans had a slightly higher predictive accuracy for subsequent events than EP study. "The number of presentations and variety of patient groups study indicates the growing interest in T-wave alternans as an important diagnostic tool for the identification of patients at risk of arrhythmias and sudden death," stated Mr. Arnold.

About the Cambridge Heart Alternans Test

The Cambridge Heart Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected using proprietary Alternans Sensors while the heart rate is elevated by exercise, use of pharmacological agents or pacing. Extensive clinical research has shown that patients with symptoms of or at risk of life threatening arrhythmias who test positive for T-wave alternans using Cambridge Heart technology are at significant risk for subsequent sudden cardiac events including sudden death. Cambridge Heart's Alternans Test is the only FDA-cleared noninvasive test to identify patients at risk for sudden cardiac death Sudden Cardiac Death Definition

Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest.
.

About Cambridge Heart. Inc.

Cambridge Heart is engaged in the research, development and commercialization of products for the noninvasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest, the early detection of coronary artery disease and the prompt and accurate diagnosis of heart attack. The Company, started in 1992, is based in Bedford, Mass., and is traded on the NASDAQ/NMS under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com.

Statements made in this press release that are not historical facts include forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include uncertainties associated with regulatory approval processes and other factors that are included in Cambridge Heart's Annual Report on Form 10-K for the year ending December 31, 1998.
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Publication:Business Wire
Geographic Code:1USA
Date:May 17, 2000
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