Thursday, January 24, 2008
Reliant® Noninvasive Cardiac Output Monitor Gets FDA OK
Filed under: Anesthesiology
, Cardiology
, Critical Care
, Medicine
Reliant® from Israel-based Cheetah Medical, Inc. has been approved by the FDA, according to a report at Globes and a press release. The device promises the accuracy of measurements of cardiac output equal or better to traditional Swan-Ganz catheter. The device functions via a proprietary NICOM® technology, that is based on a traditional bioimpedance analysis (changes in voltage of electrical currents traversing the patient's chest), plus BIOREACTANCE® technology, an analysis of frequency related effects:
The NICOM® ICU (Intensive Care Unit) and CCU (Critical Care Unit) is a non-invasive Cardiac Output monitor based on Haemodynamic Reactance Mapping, intended for the measurement and display of Cardiac Output and ECG (electrocardiogram), both at rest and under medical tests.In ICU, non-invasive Cardiac Output monitoring by the NICOM® provides haemodynamic information, which assists in diagnosis and therapy of heart patients by establishing the patient's baseline haemodynamic status for optimization of drug titration. The NICOM® contributes to the reduction of procedures involved with invasive PAC (Pulmonary Artery Catheter) by replacing it whenever the non-invasive NICOM® product can be utilized and also by enabling earlier removal of PAC.
The NICOM® approach incorporates a novel front end concept together with a unique electrode concept, placed on upper and lower positions of the thorax.
The NICOM® system allows superior accuracy of better than ± 5% as found in preclinical study versus Cardio Pulmonary Bypass Pump. It should be noted that the acceptable bias limit for the Swan-Ganz in the medical community is ± 20%.
A low-level electrical current is emitted and received by adjacent electrodes, while the response to the current flow produces the Haemodynamic Reactance waveform.
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