Healthcare Industry News:  hemodialysis 

Devices Cardiology Monitoring FDA

 News Release - January 22, 2008

FDA Approves Cheetah Reliant(TM) for Noninvasive Cardiac Output Monitoring (NICOM(R))

Cheetah Medical Inc. Introduces New System to Measure Accurately, and Non-Invasively Patients' Cardiac Output and Other Hemodynamic Parameters

INDIANAPOLIS, Indiana, January 22 (HSMN NewsFeed) -- Cheetah Medical Inc. announces the U.S. Food and Drug Administration (FDA) approved for marketing the Reliant, a highly accurate, portable cardiac output monitor which provides a noninvasive window to cardiac and hemodynamic function. The Reliant monitor is powered by Cheetah's unique, patented BIOREACTANCEŽ Technology, which has been used effectively in over 1,000 patients in various clinical settings including hemodynamic monitoring, heart failure, perioperative care, hemodialysis and stress testing.

About the Reliant technology

Reliant harnesses the innovative NICOMŽ system which combines traditional impedance technology with BIOREACTANCEŽ Technology. Traditional bioimpedance analyzes changes in voltage of electrical currents traversing the patient's chest, while BIOREACTANCE also analyzes frequency related effects. NICOM's hybrid analysis helps deal with electrical noise interference, patient movement, respiration and electrode misplacement. As a result, NICOM enables a highly precise, accurate and responsive measurement of cardiac function and hemodynamic status not available with other modalities. This can be likened to improved quality of Frequency Modulation (FM) versus traditional Amplitude Modulation (AM).

Cardiac Output Monitoring

Cardiac output monitoring has been shown in the context of specific treatment algorithms to reduce morbidity, mortality and length of hospital stay in a number of conditions including perioperative care, intensive care and trauma while also providing clinical value in heart failure and dialysis. Those conditions represent major ailments with significant associated costs. However, leading cardiac output modalities are invasive and costly while other approaches have not provided enough accuracy. Consequently, Cheetah Medical believes that cardiac output is not obtained in millions of cases per year where it can be of value and that NICOM is the solution physicians have been waiting for.

"Across the world", Yoav Avidor, M.D., Chief Executive Officer of Cheetah Medical Inc. says, "the healthcare environment struggles to provide quality care to an aging population while dealing with efficiency and economic constraints. There is a global push to reduce invasive, costly procedures that can lead to complications and require a highly skilled physician to deploy. Hospitals seek better solutions in terms of efficiency, cost and scalability to more patients who can be treated in less acute settings, without impacting quality of care. Reliant can help physicians and hospitals do just this while maintaining and potentially improving quality of care."

Pierre Squara, MD, from Clinique Ambroise Pare, Paris, France who recently published research on 110 surgical patients monitored with NICOM as compared to the invasive thermodilution gold-standard, says, "In the intensive care unit, accurate cardiac output empowers common, critical decisions, for example optimization of fluid management, a key goal with high impact on outcomes. Existing techniques which we have historically used required vascular access through large veins or arteries. This took valuable time, sometimes let to complications and higher costs which my hospital is increasingly sensitive to. The introduction of a simple, non-invasive device to attain accurate measurements is a major advance in intensive care medicine. "

US General Manager Laura Rector stated, "We believe that with Reliant healthcare professionals see a device that can deliver a new standard of care. The uniqueness of this technology lies in its proven ability to provide accurate, reliable, affordable and completely non-invasive information, even during patient movement, in environments with significant electrical noise and under highly challenging clinical circumstances. Ultimately, if you can evaluate the health of a patient's heart accurately in non-invasive fashion with only a few sticker electrodes, the question becomes not when would you want to use the Reliant, but why wouldn't you use it?"

About the Company

Cheetah Medical is a privately held company with offices in Israel, Indianapolis, Indiana and the UK. Cheetah Medical is preparing to launch its sales and marketing activities for the US and European markets.

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Source: Cheetah Medical

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