Portable pneumatic driver for counterpulsation therapy

描述（由申请人提供）：SCR，Inc.（Louisville，KY）正在开发慢性可植入CPD系统以治疗可能对长期反搏支持有反应的HF患者。CPD已开发用于通过起搏器切口进行浅表植入，而无需进入胸部，并使患者能够完全移动。CPD是一个32 ml的每搏输出量聚乙烯内衬血室，设计用于舒适地安装在植入式心律转复除颤器（ICD）或双心室起搏器植入部位对侧右前胸的皮下囊袋中。泵室通过短的ePTFE移植物连接到体循环，该移植物与腋动脉相连。CPD由一个小型、可穿戴的气动驱动器控制，通过经皮空气管路连接，并由患者的ECG触发。CPD在天然心脏收缩期填充，降低心室工作负荷，并在舒张期增加心肌和终末器官灌注。在I期研究中，在一系列生理条件（低血压、高血压和心力衰竭）下，在大型动物模型（n=12）中，32 ml CPD驱动器的血流动力学有效性等同于标准市售40 ml IABP，证明了其可行性。在本II期研究中，将完成CPD驱动程序的开发和测试，以支持未来的FDA申报。该目标将通过（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驱动器的长期安全性来实现。将完成关键药物非临床研究质量管理规范（GLP）研究的结果，并编写一份总结报告，提交给美国食品药品监督管理局（FDA），以申请批准临床试验。这里详细介绍的计划利用了SCR的开发工作以及Abiomed（Danvers，MA）的工程和开发团队。这种伙伴关系将由犹太医院（路易斯维尔，肯塔基州）的创新医生小组和路易斯维尔大学（UofL）心血管创新研究所（CII）的世界级研究团队提供协助和指导。我们的长期目标是将CPD系统成功引入临床，作为长期反搏治疗，治疗晚期NYHA III级和早期NYHA IV级HF患者，帮助恢复他们的生活质量。公共卫生相关性：SCR，Inc.（Louisville，KY）正在开发长期反搏装置（CPD）以治疗早期心力衰竭患者。CPD是为浅表植入而开发的，无需进入胸部，患者可以携带的便携式气动驱动器可以恢复活动性。

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.