Healthcare Industry News: Microvolt T-Wave Alternans
News Release - May 19, 2008
Microvolt T-Wave Alternans Found to Be Highly Accurate Predictor of Arrhythmic Events in Meta-Analysis of 6,000 Patients
Presentation at Heart Rhythm Society 2008 Scientific Session Supports Use of Cambridge Heart Technology as Predictor of Sudden Cardiac DeathTEWKSBURY, Mass.--(HSMN NewsFeed)--Cambridge Heart, Inc. (OTCBB: CAMH ), today announced that a meta-analysis of Microvolt T-Wave Alternans (MTWA) studies was presented by Dr. Stefan Hohnloser at the Heart Rhythm Society 2008 Scientific Sessions in San Francisco. The study entitled “Predictive Accuracy of Microvolt T-Wave Alternans Testing in Primary Prevention Patients With and Without ICDs” analyzed 14 recent trials, which collectively enrolled approximately 6,000 patients.
The results showed that MTWA was a highly accurate predictor of arrhythmic events in those studies which used sudden cardiac death or sustained arrhythmias as the primary endpoint. In contrast, results from studies such as the MASTER trial, in which “appropriate” ICD discharge was the predominant endpoint, MTWA did not demonstrate similar predictive accuracy.
Dr. Hohnloser, Director of Electrophysiology at J.W. Goethe University in Frankfurt, Germany, noted that “appropriate” ICD therapy appears to be an unreliable surrogate endpoint for sudden cardiac death and can significantly impact the outcome of risk stratification studies. "These results demonstrate that MTWA is a consistently accurate predictor of sudden cardiac death and cardiac arrest in patients who do not already have implanted ICDs. These are the patients for whom MTWA testing is intended," said Dr. Hohnloser.
Ali Haghighi-Mood, Cambridge Heart Chief Executive Officer, commented on the large number of MTWA presentations at this year’s HRS conference and noted the significance of Dr. Hohnloser’s findings. “This comprehensive analysis will help to remove any lingering confusion in the marketplace resulting from studies like MASTER which used “appropriate” ICD therapy as the predominant endpoint.”
The abstract of Dr. Hohnloser’s presentation can be viewed at:
http://www.hrsonline.org
About Cambridge Heart, Inc.
Cambridge Heart (www.cambridgeheart.com) is engaged in the development and commercialization of products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary Microvolt T-Wave Alternans measurement technologies, coupled with its patented Spectral Analytic Method and ultra-sensitive disposable electrode sensors. Only Spectral Analytic Method MTWA tests are reimbursed by Medicare under its National Coverage Policy that covers patients with a wide variety of cardiac symptoms. Other major insurers in the USA also have coverage policies for the test. The T-Wave Alternans test is included in the Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death jointly developed by the American College of Cardiology (ACC), The American Heart Association (AHA) and the European Society of Cardiology (ESC). The Company, founded in 1990, is based in Tewksbury, Massachusetts and is traded on the OTCBB under the symbol CAMH.
About the Cambridge Heart Microvolt T-Wave Alternans Test
The Cambridge Heart Microvolt T-Wave Alternans Test measures a specific extremely subtle pattern of beat-to-beat fluctuations in a person's electrocardiogram. This pattern of fluctuations is called T-wave alternans. These tiny variations in the electrocardiogram - measured at one millionth of a volt accuracy – are most commonly measured during a sub-maximal exercise stress test in the doctor’s office or hospital outpatient setting. The preparation for the test consists of placing proprietary sensors on the patient's chest. Extensive clinical research has shown that those patients who are at risk of ventricular tachyarrhythmia that test positive for Microvolt T-Wave Alternans are at increased risk for sudden cardiac death, while those who test negative are at reduced risk.
Statements contained in this press release are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. In some cases, we use words such as “believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences include failure to achieve broad market acceptance of the Company’s MTWA technology, failure to achieve broad market acceptance of the Company's MTWA technology, failure of our sales and marketing partner to market our products effectively, inability to hire and retain qualified clinical applications specialists in the Company's target markets, failure to obtain or maintain adequate levels of third-party reimbursement for use of the Company's MTWA test, customer delays in making final buying decisions, decreased demand for the Company's products, failure to obtain funding necessary to develop or enhance our technology, adverse results in future clinical studies of our technology, failure to obtain or maintain patent protection for our technology and other factors identified in our most recent Annual Report on Form 10-K/A under “Risk Factors”, which is on file with the SEC and available at www.EDGAR.com. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as may be legally necessary, even if our estimates should change.
Source: Cambridge Heart
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