Research in the Lancet Finds Cambridge Heart's T-wave Alternans Technology Successfully Identifies Heart Failure Patients At Risk for Sudden Death.Business/Technology Editors BEDFORD, Mass.--(BUSINESS WIRE)--Aug. 18, 2000 Non-invasive technology identifies risk for patients with no prior history of ventricular arrhythmias An article to be published in the August 19th issue of the prestigious British medical journal The British Medical Journal, or BMJ, is one of the most popular and widely-read peer-reviewed general medical journals in the world.[2] It is published by the BMJ Publishing Group Ltd (owned by the British Medical Association), whose other , The Lancet, demonstrates that Cambridge Heart, Inc.'s (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 ) T-wave alternans technology is the most effective non-invasive test to identify congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. (CHF CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ) patients at risk for developing life-threatening abnormal heart rhythms. The study results suggest that the Microvolt microvolt one-millionth (10-6) of a volt; abbreviated µV. T-Wave Alternans Test can help save lives by enabling clinicians to accurately assess the risk of 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. among CHF patients with no prior history or symptoms of abnormal heart rhythms, and to initiate appropriate preventive therapy. Congestive heart failure affects almost 5 million Americans, with 550,000 new cases occurring each year, and sudden cardiac death occurs at six to nine times the rate of the general population in patients diagnosed with CHF. "Each year, approximately 100,000 congestive heart failure patients die suddenly from heart rhythm disorders. Until now, there has not been an accurate, non-invasive test to determine which CHF patients are at risk for sudden cardiac death," said Richard Cohen, M.D., Ph.D., Whitaker Professor in the Harvard - M.I.T. Division of Health Sciences and Technology and Chairman of the Cambridge Heart Scientific Advisory Board. "This study demonstrates that microvolt T-wave alternans can play an important role in identifying which CHF patients will benefit from preventive therapy and which are not in need of expensive and potentially invasive therapies." Study Results Support Predictive Value of T-Wave Alternans Researchers followed 107 CHF patients with no prior history of sustained ventricular arrhythmias for 18 months. Microvolt level T-wave alternans was measured non-invasively in these patients using Cambridge Heart, Inc.'s CH 2000 system during a standard stress test. Six other clinical measures that have traditionally been used to assess the risk of sudden death were also obtained for the patients involved in this study. Of all seven measures, microvolt T-wave alternans was the only statistically significant predictor of sudden death. Among those patients with a positive T-wave alternans test, the rate of sudden death or resuscitated re·sus·ci·tate v. re·sus·ci·tat·ed, re·sus·ci·tat·ing, re·sus·ci·tates v.tr. To restore consciousness, vigor, or life to. See Synonyms at revive. v.intr. To regain consciousness. life-threatening arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of was 21 percent at 18 months following the test. "The publication of these study results in The Lancet enables us to reach a broad audience with further scientific validation of the utility of microvolt T-wave alternans as a predictor of sudden cardiac death in this large and growing patient population," said Jeffrey M. Arnold, Chairman, President 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. , Cambridge Heart, Inc. "The potential application of our technology as a tool to stratify strat·i·fy v. strat·i·fied, strat·i·fy·ing, strat·i·fies v.tr. 1. To form, arrange, or deposit in layers. 2. the risk of sudden cardiac death for CHF patients, combined with the recent 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 of our Heartwave(TM) System, will provide a significant boost to the Company's marketing and reimbursement efforts." About the Cambridge Heart Microvolt Alternans Test The Cambridge Heart Microvolt Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called microvolt 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 for 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 noninvasive test cleared by FDA to identify patients at risk for sudden cardiac death. About Cambridge Heart, Inc. Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive 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 coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , 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 31,1999. |
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