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Cambridge Heart (OTCBB-CAMH) today announced that it has received clearance from the U.S. Food and Drug Administration to begin marketing in the United States of its new Heartwave II System for the measurement of Microvolt T-Wave Alternans (MTWA). Product availability is immediate. The Heartwave II System is a stand alone device to measure Microvolt T-Wave Alternans to help predict an individual's risk of sudden cardiac death. Unlike the original Heartwave System, the Heartwave II does not require a host stress exercise system to control the treadmill or to monitor the patient's ECG or electrical activity of the heart. The Heartwave II can accomplish all of the elements necessary to independently perform a MTWA test. Running on a Microsoft Windows(R) XP operating system, the look and feel of the Heartwave II is more familiar for the user. The Pentium(R) processor included in the Heartwave II can process information up to 15 times faster than the original Heartwave. Its substantially increased memory capacity can store 300 times more patient studies. "The development of this third generation Microvolt T-Wave Alternans system is a credit to the creativity of our engineering team," stated David Chazanovitz, President and CEO of Cambridge Heart. "The Heartwave II came about from feedback received from our customer base with respect to ways to increase the utility of the device. In addition to running our clinically proven Alternans algorithm, the system can also perform a complete stress exercise test."
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 at risk of life threatening arrhythmias who 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.
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 under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com Windows(R) XP is a trademark of Microsoft Corporation in the United States and in other countries. Pentium(R) is a trademark of Intel Corporation in the United States and in other countries. Statements contained in this press release that are not purely historical, 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 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.
KEYWORD: NORTH AMERICA MASSACHUSETTS UNITED STATES INDUSTRY KEYWORD: HEALTH CARDIOLOGY MEDICAL DEVICES PRODUCT/SERVICE PHOTO/MULTIMEDIA SOURCE: Cambridge Heart, Inc.
CONTACT INFORMATION: Cambridge Heart, Inc. Robert B. Palardy, 781-271-1200 ext 231 CFO bobp@cambridgeheart.com or Investors: Consulting For Strategic Growth Stan Wunderlich, 800-625-2236 cfsg@consultant.com
Posts: 352 | Registered: Jan 2005
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