Noninvasive Test Identifies Coronary Disease

The test has been cleared by the U.S. Food and Drug Administration (FDA) for use as an aid in the detection of coronary artery endothelial dysfunction.

Called Endo-PAT 2000, the system has three components. Peripheral arterial tonometry (PAT) signals are obtained using two disposable probes placed on the fingers of the test subjects. A portable unit connects to and operates the probes, and signal analysis and the endothelial dysfunction report are generated via a laptop computer. Endothelial dysfunction assessments can be completed in 20 minutes.

A clinical study was conducted at the Mayo Clinic (Rochester, MN, USA), where researchers investigated the value of the Endo-PAT. Through invasive testing in the catheterization lab of the 94 participating patients, coronary endothelial dysfunction was found in 55 patients. By comparing these results against the Endo-PAT, the researchers found a threshold value for the fingertip test that would have identified the majority of the patients with early heart disease. Their findings were reported in the December 7, 2004, Journal of the American College of Cardiology.

"All of the currently available tests for the assessment of endothelial function are more or less invasive or operator-dependent, which precludes their use as a screening tool in clinical practice,” commented Amir Lerman, M.D., F.A.A.C., a cardiologist from Mayo Clinic. "In contrast, the Endo-PAT is noninvasive, easy to perform and operator-independent. We found a strong correlation, and that the fingertip test was very sensitive in identifying patients with early heart disease.”

Endo-PAT was developed by Itamar Medical (Caesarea, Israel), a company pioneering the introduction to medicine of a noninvasive window to the autonomic nervous system and arterial health. The company notes that Endo-PAT is the only system to be cleared by the FDA for the detection of coronary artery endothelial dysfunction. In the United States, the Endo-PAT system is distributed by Cholestech Corp. (Hayward, CA, USA).

The Endo-PAT 2000 is undergoing continuing clinical investigation at major medical centers such as Harvard, Yale, and Mayo Clinic. In addition, drug companies developing new agents to treat endothelial dysfunction are now including it in trials, and it was recently incorporated into the Framingham Heart Study.





Related Links:
Mayo Clinic
Itamar Medical