NIH Sponsored Study in JACC Extends Predictive Ability of Microvolt T-Wave Alternans; Non-invasive study shown effective in identifying patients both at high and low risk of sudden cardiac death.BEDFORD, Mass. -- Cambridge Heart, Inc. (OTCBB-CAMH) today announced the publication of an NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. sponsored study in the online version of JACC JACC Journal of the American College of Cardiology JACC Java Authorization Contract for Containers JACC Joint Automatic Control Conference JACC Journal Access Core Collection JACC Joint Ambulatory Care Clinic JACC joint airspace control center - 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. . The study, receiving expedited review, is titled, "Microvolt microvolt one-millionth (10-6) of a volt; abbreviated µV. T-Wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients with Left Ventricular Dysfunction." Conducted in 11 clinical centers, the study enrolled 549 patients with left ventricular dysfunction as measured by an ejection fraction (measure of the heart's pumping efficiency) less than or equal to 40%. All patients exhibited symptoms of clinical heart failure but importantly had no history of sustained ventricular arrhythmias. The population studied is similar to the individuals studied in the well publicized 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. in Heart Failure Trial (SCD-HeFT) published in the January 2005 issue of The New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. . This publication expands on the initial findings of the authors, published in Circulation in September 2004, on a subset of this population which met the well documented 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 II criteria. In this study population Microvolt T-Wave Alternans (MTWA MTWA Microvolt T-Wave Alternans MTWA Maximum Total Weight Authorised MTWA Metro Toronto Wrestling Association MTWA Maximum Takeoff Weight Authorized ) was shown to be highly effective at separating individuals at very low risk of death or ventricular arrhythmia from those at high risk. Utilization of MTWA as a risk stratifier can thus make possible the potential for more appropriate use of implantable cardioverter defibrillators (ICDs). Based on a two year actuarial rate for both sudden death and ventricular arrhythmias, an individual testing MTWA abnormal was 6.5 times more likely to have an event than a patient testing MTWA normal / negative. Most significantly, MTWA was the most effective risk stratifier and an independent predictor of events regardless of ejection fraction and 6 other confounding variables including two additional measures of heart failure severity. The Principal Investigator, Dr. Daniel Bloomfield, Adjunct Associate Professor of Medicine, Columbia University College of Physicians and Surgeons The Columbia University College of Physicians and Surgeons, abbreviated P&S, is a graduate school of Columbia University located on the health sciences campus in the Washington Heights neighborhood of Manhattan. , commenting on the results of the study said, "This study demonstrates that a MTWA test, which can be easily performed in the doctor's office, clearly separates a large group of patients who are unlikely to benefit from implantation of an ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. from those who may benefit from the device." David A. Chazanovitz, 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. of Cambridge Heart, Inc. commented, "We appreciate the hard work from this outstanding group of clinical investigators. The results strongly confirm our belief that the use of MTWA can add a significant element of efficiency in the utilization of life saving ICDs. The use of MTWA in this patient population can assist physicians and their patients in making the best possible decisions for appropriate care." The study can be found at: http:// content.onlinejacc.org/cgi/content/abstract/j.jacc.2005.11.026v1 (Due to the length of this URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. , it may be necessary to copy and paste To copy files from one location to another or to copy text and images from one document to another. All modern operating systems and applications have a copy and paste capability that is typically selected from an Edit menu. See cut and paste and Win Copy between windows. it into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.) About Cambridge Heart 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 Company's products incorporate its proprietary technology, Microvolt T-Wave Alternans, and are the only diagnostic tools cleared by the U.S. Food and Drug Administration to non-invasively measure microvolt levels of T-wave alternans. The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB OTCBB See OTC Bulletin Board (OTCBB). under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com About the Cambridge Heart Microvolt T-Wave Alternans Test The Cambridge Heart Microvolt T-Wave 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 in any clinical setting where titration of the heart rate is possible. The preparation for the test consists of placing proprietary sensors on a patient's chest. Extensive clinical research has shown that patients with symptoms of, or who are at risk of, life threatening arrhythmias that test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk. Statements contained in this press release about anticipated revenue growth, and all other statements that are not purely historical, are forward-looking statements for purposes of the safe harbor provisions under 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. 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 customer delays in making final buying decisions, decreased demand for our 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, failure to obtain or maintain adequate levels of third-party reimbursement for use of our products and other factors identified in our most recent Annual Report on Form 10-K under "Factors Which May Affect Future Results", which is on file with the SEC. 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, even if our estimates change. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion