Cardiomedics, Inc. is an External Counterpulsation Therapy device manufacturer in established in 1986. The company was located in Irvine, California but closed their doors as an active ECP company. There is some speculation of a new company but as of now, there is no evidence of their existence.
Cardiomedics had several claims for being “first” in history to achieve several landmarks in the development of the External Counterpulsation Therapy marketplace. Cardiomedics was the first company in the U.S. to have FDA Cleared External Counterpulsation Therapy (ECP) system called the CardiAssist. Cardiomedics had relatively strong success as they were essentially the only competition to Vasomedical in the early 2000’s. The Cardiassist ECP device was also the first of its kind to be digital with a flat-screen / touch screen monitor. This device was a hot seller for a period of time before other companies caught up to releasing a digital ECP device.
As far as clinically, Cardiomedics was also the first ECP company to published a clinical study in a peer reviewed journal that demonstrates that ECP significantly reduces the annual mortality of congestive heart failure patients (Class II, III, IV) to less than 2%, while reducing re-hospitalization by over 85%. Cardiomedics along with others in the industry hold on to big expectations that there will someday be an approval of Congestive Heart Failure in the U.S.
In addition, Cardiomedics was the first company to introduce a 4-8 minute sub-maximal cardiopulmonary exercise test (the CardiAssess CPD) for the diagnosis and management of cardiovascular risk. A non-invasive way of tracking a patient’s physiological changes, the CardiAssess can be used to make an initial diagnosis and also track the efficacy of ANY medical treatments a patient is receiving.
Product Technology
As indicated above, Cardiomedics was clearly a serious competitor in the early development stages of the External Counterpulsation industry. As the first company to have FDA market clearance in the U.S., Cardiomedics was capable of competing successfully based on some early clinical research, as well as a device with (at that time) >more advanced capabilities than the competition.
All of Cardiomedics ECP devices have a unique configuration that allows the device to be used for “mobile applications”. Although this component of the industry has yet to evolve, the Cardiassist External Counterpulsation Therapy device was a marketable feature as its main competition was the MC-2 & TS-3 model devices from Vasomedical. The Cardiassist ECP device operates with a Microsoft Windows operating system and uses a “low pressure” concept to deliver therapy. The “low pressure” concept as been touted as a more comfortable, more tolerable treatment than many of the other devices.
For more product features of Cardiomedics device technology, download our Free “ECP Product Comparison” and visit “ECP & EECP® Product Reviews” to see how the CardiAssist device technology (CardiAssist 3000, CardiAssist 4500) from Cardiomedics stacks up versus the competition.
Legal & Safety Notice
Cardiomedics reported a FDA Warning Letter for lack of quality assurance procedures in the manufacturing process.
