Technology | September 10, 2009

FDA Clears Asymptomatic Heart Failure Detection Device

September 10, 2009 – NI Medical Ltd. said yesterday it received FDA approval for its NICaS CS, a new device for the assessment of left ventricular systolic dysfunction (LVSD), to detect heart failure in its preclinical, asymptomatic phase.

The NICaS device uses impedance technology for measuring cardiac output, cardiac index, cardiac power, stroke index, total peripheral resistance, etc. This company said the device offers accurate results with a bioequivalence with the thermodilution technique.

It uses a new algorithm, the Granov Goor Index (GGI), which allows primary care physician to detect the LVSD asymptomatic phase during an ordinary physical examination.

The GGI may help in diagnosing a fraction of patients who will suffer sudden cardiac death (SCD). Of the total 650,000 annual deaths from coronary heart disease in the United States, approximately 350,000 succumb to SCD. The main cause of SCD, a condition called hibernating myocardium, accounts for approximately 35-40 percent of the 350,000 cases of SCD.

“By detecting these ‘hibernating’ cases in a timely manner, most of the lives of these individuals can be saved,” said Daniel Goor, M.D., chairman and chief investigator at NI Medical.

To use the NICaS, a doctor, nurse, or medical technician simply places one double electrode on the patient’s wrist and one on the ankle. The patient does not need to undress or be shaved. The entire process takes three to four minutes.

The NICaS electrodes are connected to the impedance device, which is situated within a laptop computer in place of the CD-ROM, and the laptop’s screen serves as the monitor.

The Framingham Study determined the diagnostic parameters of the so-called asymptomatic LVSD in 2003. It was because of the high economic burden of screening the population for the treatment of this malady that this enterprise was abandoned. However, with the advent of the GGI, the company said the nominally-priced NICaS CS ca diagnose at least 40 percent of asymptomatic LVSD cases.

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