Portable pneumatic driver for counterpulsation therapy

描述（由申请人提供）：SCR, Inc. （Louisville， KY）正在开发一种慢性植入式CPD系统，用于治疗可能对长期反搏支持有反应的HF患者。CPD通过心脏起搏器切口进行浅表植入，无需进入胸部，使患者能够完全活动。CPD是一个32毫升的中风容积聚氨酯内衬血室，设计用于舒适地放置在右前胸的皮下口袋中，对侧是植入式心律转复除颤器（ICD）或双心室起搏器植入部位。泵腔通过与腋窝动脉吻合的短ePTFE移植物与体循环相连。CPD由一个小型的可穿戴气动驱动器控制，通过经皮气管连接，并由患者的心电图触发。CPD在心脏收缩期充盈，降低心室负荷，在舒张期射血，增加心肌和终末器官灌注。在I期研究中，在一个大型动物模型（n=12）中，在一系列生理条件（低血压、高血压和心力衰竭）下，32ml CPD驱动剂的血流动力学疗效相当于标准的市售40ml IABP，证明了其可行性。在这项II期研究中，CPD驱动程序的开发和测试将完成，以支持未来向FDA提交申请。这一目标将通过(1)完成工程开发，(2)证明可靠性和人体工程学，以及(3)证明CPD驾驶员的长期安全性来实现。一项关键的良好实验室规范（GLP）研究的结果将完成，并准备一份摘要报告，提交给美国食品和药物管理局（FDA），要求批准临床试验。这里详细介绍的项目利用了SCR的开发工作以及Abiomed （Danvers， MA）的工程和开发团队。这一伙伴关系将得到犹太医院（肯塔基州路易斯维尔）的一个创新医生小组和路易斯维尔大学心血管创新研究所（CII）的一个世界级研究团队的协助和指导。我们的长期目标是成功地将CPD系统引入临床，作为治疗晚期NYHA III级和早期NYHA IV级HF患者的长期反搏治疗，并帮助恢复他们的生活质量。公共卫生相关性：SCR， Inc. （Louisville， KY）正在开发一种长期反搏装置（CPD）来治疗早期心力衰竭患者。CPD已被开发用于不需要进入胸部的浅表植入，并且患者可以携带便携式气动驱动器恢复活动能力。

DESCRIPTION (provided by applicant): SCR, Inc. (Louisville, KY) is developing a chronic implantable CPD system to treat HF patients who may be responsive to long-term counterpulsation support. The CPD has been developed for superficial implantation via a pacemaker incision without the need to enter the chest and enables complete patient mobility. The CPD is a 32-ml stroke volume polyurethane-lined blood chamber designed to fit comfortably in a subcutaneous pocket on the right anterior chest contralateral to an implantable cardioverter defibrillator (ICD) or biventricular pacer device implantation site. The pumping chamber is connected to the systemic circulation by a short ePTFE graft anastomosed to the axillary artery. The CPD is controlled by a small, wearable pneumatic driver, connected by a percutaneous air line, and triggered by the patient's ECG. The CPD fills during native heart systole lowering ventricular workload, and ejects during diastole augmenting myocardial and end-organ perfusion. In the phase I study, the hemodynamic efficacy of the 32-ml CPD driver was equivalent to a standard commercially-available 40-ml IABP in a large animal model (n=12) over a range of physiologic conditions (hypotension, hypertenstion, and heart failure) demonstrating feasibility. In this phase II study, the development and testing of the CPD driver will be completed to support a future FDA submission. This objective will be accomplished by (1) completing engineering development, (2) demonstrating reliability and ergonomics, and (3) demonstrating long-term safety of the CPD driver. Results of a pivotal Good Laboratory Practices (GLP) study will be completed with a summary report prepared for submission to the Food and Drug Administration (FDA) to request approval for clinical trials. The program detailed here leverages the development work of SCR and the engineering and development teams at Abiomed (Danvers, MA). This partnership will be assisted and guided by an innovative group of physicians at Jewish Hospital (Louisville, KY) and a world class research team in the Cardiovascular Innovation Institute (CII) at the University of Louisville (UofL). Our long-term objective is to successfully introduce the CPD system into the clinic as a long-term counterpulsation therapy to treat late NYHA class III and early NYHA class IV HF patients and help restore their quality of life. PUBLIC HEALTH RELEVANCE: SCR, Inc. (Louisville, KY) is developing a long-term counterpulsation device (CPD) to treat early stage heart failure patients. The CPD has been developed for superficial implantation without the need to enter the chest and a portable pneumatic driver that the patient can carry restores mobility.