Myocardial ischemia sensor for implantable pacemakers

描述（由申请人提供）：心脏病发作后存活的关键是 快速建立再灌注治疗。70分钟内开始治疗 与死亡率降低7倍有关 与从70- 120分钟开始的治疗相比（1.2%对8.7 %）。 每年有577，000名患者需要安装起搏器， 高风险我们提出了一种技术，使这些设备能够检测 心肌缺血和新发梗死。IMMedDIATE（植入式 心肌缺血检测指示和动作技术）将保存 通过及时提醒患者寻求治疗，它 利用创新的基于经静脉导线的电极配置和QRS 基于去极化的局部缺血检测。这允许一种解决方案， 有吗不需要更多的侵入性硬件或手术。 我们已经完成了初步的工作，分析非起搏节拍在猪 模型立即成功识别31/31次缺血发作和0/12次 对照组：100%灵敏度和100%特异性。我们现建议 以进一步开发在心脏起搏期间使用的技术。第一阶段 努力的重点是硬件和软件的开发和测试 满足缺血检测的独特需求， 心室起搏 从长远来看，我们的目标是许可IMMeDIATE用于植入式 心脏设备它将作为一个哨兵，从而最大限度地减少发病率 冠心病患者的死亡率 IMMeDIATE起搏器。 拟议的商业应用： IMMeDIATE的商业应用有明确的定义。每年有577，000人接受起搏器。他们是心肌梗死的高危人群。在该患者人群中部署IMMeDIATE将有助于建立快速治疗，从而最大限度地降低该疾病的发病率和死亡率。

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.