Cambridge Heart announces results of a clinical study to be used in support of an expansion of its labeling claim.BEDFORD, Mass.--(BW HealthWire)--March 19, 1997--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) announced today that a clinical study conducted at the G.W. Goethe University, Frankfurt, under the direction of Dr. Stefan Hohnloser, demonstrating the use of T-Wave alternans in patients with 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. ), will be presented in a poster session today at the America College of Cardiology meeting in Anaheim, Calif. This study presents the results of using T-wave alternans (TWA) measured with the Cambridge Heart CH 2000 to predict life threatening arrhythmia in 70 patients with congestive heart failure (CHF) and compares TWA to other non-invasive risk factors. The abstract was published in the February Supplement to the Journal of the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. . This study is continuing with additional patients being recruited. Cambridge Heart intends to use this study as supplemental data for its 510(k) submission to the 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. , expected in the second calendar quarter of this year, to obtain an expansion of the labeling claims for the CH 2000 System. This submission will primarily utilize data from another 100 patient study, currently underway, which compares TWA to Signal Averaged ECG (SAECG) in its ability to predict the results of electrophysiology study, an invasive measure of arrhythmia risk. The intention of this study is to demonstrate that TWA is at least equivalent to SAECG in its ability to identify patients susceptible to ventricular arrhythmias. "This is a very important study for Cambridge Heart," stated Jeffrey Arnold, president and CEO of Cambridge Heart. "It provides support for our 510(k) submission and it does so in a large and important patient group." There are 4.7 million patients with CHF in the United States today with over 400,000 new cases per year -- these patients have a sudden death rate of 6 to 9 times the general population. The recent MADIT MADIT Cardiology A clinical trial–Multicenter Automatic Defibrillator Implantation Trial that evaluated the effects of implanted defibrillators–IDs in Pts with CAD at high risk of ventricular arrhythmia study demonstrated that the use of the implantable defibrillator (ICD) can significantly reduce mortality when used in a high risk subset of this population. As a result, there has been a great deal of recent interest in finding the best means to identify the highest risk patients within this group. 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 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. , 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. CONTACT: Cambridge Heart Inc. Thomas V. Hennessey Jr., 617/271-1200 |
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