1950's
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Kantrowitz and Kantrowitz first described the principle of "phase shift" diastolic augmentation.

Soroff, et al,* related this principle to the oxygen consumption difference between flow work and pressure work by the heart. It was this understanding that eventually led to the concept of a mechanically induced counter pulsation to provide assistance to patients with low cardiac output syndromes.

Direct counter pulsation techniques first developed by Harken and Associates at Harvard resulted in femoral cut-down and external pulse actuation. The technique withdrew then returned the blood to the arterial system. Studies documented increased coronary flow, decreased coronary AVO₂ difference and reduced left ventricular pressure work.
* Soroff, et. al., 1965

1960's
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During the early 60's, laboratory studies with animals demonstrated the potential efficacy of counter pulsation as a treatment following coronary occlusion. Jacobey and Associates* provided the first evidence that counter pulsation could quickly enhance the development of coronary collateral circulation. It also suggested the possible clinical application of counter pulsation to the treatment of patients with coronary insufficiency and angina.

During this same period at Harvard, Birtwell and Clauss* produced counter pulsation by introducing a catheter with a balloon into the ascending aorta via the femoral artery. The Intra-aortic Balloon Pump was thus invented. This approach has found clinical application in support of circulation during and after cardiac surgery and in cardiogenic shock.

Also in the 1960's, several scientists were involved in the evolution of counter pulsation to a completely non-invasive technique using externally applied pressure generated by hydraulic systems. The system used various materials to encase the patient's lower extremities. It then compressed the vascular bed, displacing arterial and venous blood centrally. Though these devices were somewhat primitive, several studies demonstrated the potential of this approach to increase survival in patients with myocardial infarction and cardiogenic shock as well as relief of angina pectoris.

During the late 1960's, scientists at the National Institute of Health believed that results could be improved if the blood was moved from the lower limbs in a sequential manner. The development and testing of sequenced systems determined that they achieved greater cardiac output and increased the ratio of diastolic to systolic pressures.
* Jacobey et. al, 1971, Birtwell et. al., 1970

1970's
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During the 1970's, a great deal of study was done on external counter pulsation. Among the distinguished physicians and scientists published on this subject were:

Amsterdam and Associates, Messer and Associates, Banas and Associates

Mueller and Associates, Birtwell and Associates, Parmley and Associates, Harken and Associates, Rosensweig and Associates

Jacobey and Associates, Soroff and Associates, Kennedy and Associates, Sugg and Associates, Langou and Associates, Watson and Associates, Loeb and Associates, Wemple and Associates, Leinback and Associates, Wright and Associates

Among those scientists was a group at the Cardiassist Corporation in the Chicago, Illinois area. The team developed a sequenced hydraulic device called CardiAssist. Many years of study* and development went into this device. A large multi-center study involving 258 myocardial infarction patients in 25 institutions was undertaken in the late 1970's.
* Amsterdam et. al., 1980

1980's
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Results from the 25 institution, 258 myocardial infarction patient, multi-center study* using the Cardiassist device (published in 1980), indicated those patients receiving therapy within the first 24 hours after admission had a mortality rate of 6.5% versus 14.7% in the control group.

Zheng and Associates* at Sun Yat Sen University in China, reported their studies with a newly designed sequenced pneumatic system which produced excellent results. In trials, effects of the sequenced system producing long-term symptomatic relief from chronic angina were studied. These favorable results caused numerous U.S. scientists to rethink their approach to external counter pulsation.

Cardiomedics, Inc. was incorporated under the laws of the state of Nevada on August 25, 1986. On August 29, 1986, the Company acquired the assets of CardiAssist Corporation. CardiAssist Corporation had been engaged in the development and testing of earlier versions of the Company's external counter pulsation system, which it had acquired from Medical Innovations, Inc., one of the original developers of external counter pulsation at Harvard/MIT.

Cardiomedics owns patent, manufacturing and marketing rights to CardiAssistT, a non-invasive, external counter pulsation therapy for patients with coronary artery disease. Since its inception, the Company has been engaged in development and marketing of its CardiAssistT System.

In September of 1987, the Company was the first to receive 510(k) marketing clearance from the FDA for its external counter pulsation system.
* Amsterdam et. al., 1980, Zhang et. al, 1983

1990's
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The Zheng device from China was used extensively at State University at Stony Brook, New York. Studies were performed and published by Lawson and Associates in 1992, 1993, 1995, 1997 and 1998.

A New York based company began importing the Chinese device in 1995 following the FDA's clearance to market based on substantial equivalence to the CardiAssistT device.

2000's
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Medicare approves reimbursement for angina patients.

FDA clears congestive heart failure as an indication.

The New CardiAssist Model 4000/4500

CardiAssist 4000/4500 - The Fifth Generation

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