Breakthrough noninvasive tool for early cardiovascular disease detection

Physicians and researchers now have access to a noninvasive fingertip test that can identify patients with the earliest stages of cardiovascular disease and replace testing that is done during angiography.

The device, called the Endo-PAT 2000, utilizes the PAT (Peripheral Arterial Tone) signal to identify patients with endothelial dysfunction, which is well recognized as an early stage of generalized atherosclerosis and coronary artery disease.

"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 for endothelial dysfunction in clinical practice," noted Dr. Amir Lerman from the Mayo Clinic in Rochester, Minnesota and an author of the study. "This test is noninvasive, operator-independent 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."

The Endo-PAT was evaluated in clinical research conducted at major medical centers such as the Mayo Clinic, Harvard, New England Medical Center and Yale and published recently in the Journal of the American College of Cardiology. The data collected from the portable device and its fingertip probes was compared against the gold standard invasive test of intra-coronary acetylcholine challenge, which requires the patient to undergo an invasive procedure during angiography. The non-invasive Endo-PAT was found to be equally predictive of coronary artery endothelial dysfunction as the invasive test. The FDA cleared the Endo-PAT in November 2003 and Itamar has signed its first US distribution agreement with Cholestech, a leader in point of care diagnostic testing.

The Endo-PAT is already used worldwide by dozens of research centers to explore further clinical, public health and research applications and is readily available for purchase within a research package scheme, offered by Itamar Medical Ltd. The Endo-PAT is also available to pharmaceutical companies that are now using it to assess the impact of new therapies on endothelial function. It has been recently incorporated into the Framingham Heart Study as an investigational device.

Prior to the Endo-PAT, there were no FDA-approved non-invasive devices available to researchers and physicians to reliably assess endothelial function. Endothelial dysfunction is increasingly recognized as an early stage in the development of atherosclerosis, which is at the core of cardiovascular and cerebrovascular diseases and complications of diabetes that lead to potentially fatal outcomes such as heart attack and stroke. Many commonly used therapies, including statins that are used to modify cholesterol levels and angiotensin converting enzyme (ACE) inhibitors that are used to treat high blood pressure, where shown to improve endothelial function. New more potent drugs are expected to enter the market within a few years.

"The Endo-PAT is the fifth PAT product to receive FDA clearance, and we will continue work with leading researchers and organizations worldwide to develop, commercialize and bring this important new physiologic signal to medical practice," added Dr. Koby Sheffy, Vice President and Chief Technology Officer at Itamar Medical, "and we have started last year expanding the clinical research with the Endo-PAT into new areas where it is expected to have much contribution such as diabetes, early assessment in children, erectile dysfunction and others."

The Endo-PAT 2000 was developed by Itamar Medical, which has pioneered the use of the PAT Signal into important clinical applications in cardiology and sleep medicine. The device consists of two disposable finger probes connected to a portable unit and a laptop computer that controls the system and analyzes the patient's data using specialized signal processing software.