A new device, developed in Israel, can detect coronary disease through a convenient, non-invasive fingertip test.
The Endo-PAT 2000, developed by Itamar Medical in Caesarea, assesses vascular endothelial dysfunction, an early indicator of atherosclerosis.
The Endo-Pat 2000 System consists of three components. Peripheral Arterial Tonometry (PAT) signals are obtained using two disposable probes placed on fingers of the individual being tested. 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 a 20-minute office visit.
Distributed in the United States by the Cholestech Corporation, the new device is the only one to have received clearance from the Food & Drug Administration for this use. FDA clearance was obtained after it was shown that the Endo-Pat 2000 System is equivalent with an invasive procedure that assessed endothelial dysfunction in coronary arteries.
Cholestech expects to launch the Endo-PAT 2000 for broad clinical use in 2005.
The innovative device may have a role in routine cardiac care, according to a recent study published in the Journal of the American College of Cardiology.
The paper, titled "Noninvasive Identification of Patients With Early Coronary Atherosclerosis by Assessment of Digital Reactive Hyperemia," outlined the findings of researchers from Mayo Clinic in Rochester, Minnesota. The researchers investigated the value of the Endo-PAT to assess the relationship between dysfunction in the heart region and dysfunction in extremities. Through invasive testing in the catheterization lab of the 94 patients participating, 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.
"This test is a noninvasive and easy-to-perform technique to assess peripheral endothelial function that has the potential to become a valuable tool for cardiovascular risk stratification in daily clinical practice," said Amir Lerman, M.D., F.A.C.C., a cardiologist from Mayo Clinic. "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. 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."
Itamar Medical, established in 1997, is headquartered in Caesarea, Israel and has an office in Boston, MA. The company is a pioneer in introducing to the medical community non-invasive windows to the autonomic nervous system and arterial health.