CAMBRIDGE HEART INC

Cambridge Heart, Inc., incorporated on January 16, 1990, is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. The Company sells its products primarily to cardiology group practices, hospitals and research institutions. The Company’s products incorporate its technology for the measurement of Microvolt T-Wave Alternans (MTWA). MTWA is a subtle beat-to-beat fluctuation in the t-wave segment of a patient’s electrocardiogram. All of the Company’s products, including its first generation Heartwave and second generation Heartwave II Systems, CH 2000 Cardiac Stress Test System and Micro-V Alternans Sensors, have received 510(k) clearance from the United States Food & Drug Administration (FDA) for sale in the United States.

Advertisement

The Company’s Heartwave II System is used to perform a Microvolt T-Wave Alternans (MTWA Test). The MTWA Test is performed as a diagnostic procedure. The Company’s Heartwave II System is a cardiac diagnostic system designed to support a range of standard and physician-customized protocols for the conduct of cardiac exercise stress testing. In February 2010, the Company completed the development phase of the MTWA Module. The Company has also submitted a 510(k) application for regulatory approval with the FDA. The Company’s Micro-V Alternans Sensors are single patient use, multi-segment electrodes. The Company’s CH2000 is a cardiac diagnostic system designed to support a range of standard and physician-customized protocols for the conduct and measurement of cardiac exercise stress testing.

The Company competes with GE Medical Systems.
Cambridge Heart Inc. is an American-based healthcare company that researches, develops and commercializes products for the non-invasive diagnosis of cardiac disease. It is the only company in the United States to offer a non-invasive cardiac diagnostic tool for detecting Microvolt levels of T-Wave Alternans, a beat-to-beat fluctuation in the T-wave segment of a patient’s heartbeat. It was founded in 1992 to develop and market discovery products in noninvasive cardiac diagnostics. It is headquartered in Bedford, Massachusetts.
Cambridge Heart’s portfolio of diagnostic products includes the Heartwave II System, which is used to perform a Microvolt T-Wave Alternans Test; Micro-V Alternans Sensors, the single patient use, multi-segment electrodes that are required for the Microvolt T-Wave Alternans Test; and the CH 2000 Cardiac Stress Test System, a diagnostic system designed to support a range of standard and physician-customized protocols for the conduct and measurement of cardiac exercise stress tests. It has received clearance to market its Microvolt T-Wave Alternans Test from the United States Food and Drug Administration (FDA).
Cambridge Heart markets and sells its portfolio of diagnostic products to the international medical community, including cardiology group practices, hospitals, and research institutions, through sales and distribution channels in the North America, Europe, Australia and Asia.

Group or Branch:

Address:
1, Oak Park Drive 01730, BEDFORD, MA, UNITED STATES OF AMERICA
Phone/Fax:
+1 781 271 1200
+1 781 275 8431
[email protected]
www.cambridgeheart.com

Download PDF

Advertisement