IMPLANTABLE MYOCARDIAL ISCHEMIA DETECTION TECHNOLOGY

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Coronary artery disease is the leading cause of death in the United States. One quarter of all patients who suffer an acute myocardial infarction do not seek therapy, only to learn of their condition and its associated morbidity on routine electrocardiogram. Of the patients who do seek therapy, the most important factor is the time to treatment from the onset of symptoms. Reducing this factor to less than 70 minutes is associated with a decrease in mortality from 8.7% to 1.2%. This effectiveness of therapy is often hampered by delay in seeking medical attention or a complete inability to recognize the ischemic event. Therefore, we propose research that will eventually lead to development of Implantable Myocardial Ischemia Detection Technology (IMIDT), for use in pacemakers and defibrillators. This technology will provide both long term quantitative measure of ischemic burden (silent and anginal) and identification of acute ischemic events. The immediate goal (Phase I) is to obtain proof of concept that myocardial ischemia can be accurately detected by a special multipolar intracavitarv lead based system. We intend to test the lead in an acute animal model of myocardial ischemia. We will analyze the electrical signals using a novel time-frequency window filter based on wavelet analysis algorithm as well as by conventional ischemia detection methods. The results will be validated histologically. In Phase II we will focus on a chronic porcine model and on patient studies in the cardiac catheterization laboratory. Armed with acute and chronic studies, we hope to establish a collaboration with an existing pacemaker company to develop and commercialize IMIDT for early detection of acute ischemic events and chronic monitoring of the onset and progression of ischemic heart disease. PROPOSED COMMERCIAL APPLICATIONS: It is our long term vision that IMIDT will be incorporated into implantable devices for detection and treatment of myocardial ischemia. There now exists a large population of patients with implantable pacemakers and increasingly also implantable cardioverters and defibrillators. There is a good deal of comorbidity between IMIDT and the varied indications for implantable devices. Therefore, there is an excellent market for an implantable pacemaker or cardioverter/defibrillator that also monitors the ischemic conditions of the heart. IMIDT will very likely be licenced to an established pacemaker/defibrillator company that will 'piggyback' it onto such devices.