MYOCARDIAL ISCHEMIA SENSOR FOR IMPLANTABLE PACEMAKERS

Description (provided by applicant): The key to surviving a heart attack is rapid institution of reperfusion therapy. Therapy instituted within 70 minutes of the onset of symptoms is associated with a seven-fold reduction in mortality as compared to therapy started from 70- 120 minutes (1.2 percent vs. 8.7 percent). The 577,000 patients per year who require a pacemaker are at particularly high-risk. We propose a technology that enables these devices to detect myocardial ischemia and emerging infarctions. IMMedDIATE (Implantable Myocardial ischemia Detection Indication and Action Technology) will save critical early minutes by promptly alerting the patient to seek therapy. It utilizes an innovative transvenous lead-based electrode configuration and QRS depolarization-based ischemia detection. This allows for a solution that doesn?t require more invasive hardware or surgery. We have completed preliminary work analyzing non-paced beats in a porcine model. Immediate succeeded in identifying 31/31 episodes of ischemia and 0/12 controls: 100 percent sensitivity and 100 percent specificity. We now propose to further develop the technology for use during cardiac pacing. Our Phase I effort is focused on the development and testing of a hardware and software configuration which meets the unique needs of ischemia detection during ventricular pacing. In the longer-term, our goal is to license IMMeDIATE for use in implantable cardiac devices. It will serve as a sentry, thereby minimizing the morbidity and mortality of coronary artery disease in those patients with IMMeDIATE-enabled pacemakers. PROPOSED COMMERCIAL APPLICATIONS: IMMeDIATE's commercial application is clearly defined. There are 577,000 individuals per year who receive a pacemaker. They are at high risk for myocardial infarction. Deployment oif IMMeDIATE to this patient population would aid in the institution of rapid therapy, thereby minimizing the morbidity and mortality of this disease.