Clinical Studies Completed For HeartVue's 6S Heart Screening System

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 19 Aug 2008 - 13:00 PDT

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Pegasus/Heartview LLC (PINKSHEETS: PGUZ) announced that they have now completed the required clinical studies, which are an integral part of the process required for the marketing of the Company's breakthrough HeartVue 6S Heart Screening System in North America.

The clinical studies, held from April to July 2008, were completed in accordance to the guidelines and recommendations set forth by the FDA's Section 510K Pre-Market Notification of Intent To Market, and includes test results of 170 patients of various ages, genders, races, weights and health conditions. The test results will now be analyzed, interpreted and presented to the FDA in the form of a 510K Filing. The HeartVue 6S Screening System has already obtained a CE Mark Approval in Europe in November 2006.

The HeartVue 6S Screening System provides a quick (1-2 minutes) and accurate assessment of patients with suspected coronary artery disease. The device uses only 4 standard electrodes and a dispersion mapping method analysis of low amplitude ECG signals to detect heart abnormalities and ischemia. The results are then presented as a color-coded, 3-dimensional digital heart map which reflects electrical dispersions. The device allows the tester to observe the condition of the heart muscle, as well as the intensity of the heart stress load. The test uses new information from ECG fluctuations that are usually ignored as "noise" by regular ECG devices. An image of the patient's heart, along with an electrocardiogram are produced. The HeartVue 6S System will be an invaluable screening tool for cardiologists, general practitioners, clinics, hospitals, the fitness industry, sports teams and emergency medical facilities.

Pegasus/Heartview LLC