First PAT Monitoring Devices Cleared by FDA

A device that measure peripheral arterial tone (PAT) has been cleared by the U.S. Food and Drug Administration (FDA) for use in electrocardiogram (ECG) stress testing for the detection of myocardial ischemia. PAT is a signal that monitors peripheral vascular responses to autonomic nervous system activity.

Called ETT PAT 2000, the device was developed by Itamar Medical Ltd. (Caesarea, Israel), based on advanced digital signal processing algorithms. Clinical studies have shown that an analysis of PAT can give doctors highly sensitive and accurate indicators to help identify, diagnose, and monitor a variety of medical conditions. In studies involving more than 2,000 patients, the PAT increased the sensitivity of an exercise stress test by 30% without loss of specificity and reduced non-definitive tests by more than 50%.

The PAT measures arterial pulsatile volume changes in the fingertip by using noninvasive finger-mounted probes. These volume changes have been shown to mirror changes or anomalies in autonomic nervous system activity and related vascular events. In the application approved by the FDA, the probes are used in conjunction with an ECG during standard exercise stress testing. In addition to cardiac applications, PAT can be useful in sleep medicine and neurologic disorders, says Itamar.

"The PAT signal is an entirely new window into human physiology,” notes Barry L. Zaret, M.D., professor of medicine, Yale University School of Medicine (New Haven, CT, USA). "Cardiovascular response to autonomic nervous system regulation can be independent of the patient's blood pressure, oxygen saturation, or ECG changes.”




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