Development of a Counterpulsation Therapy Device

描述（由申请人提供）：SCR, Inc. （Louisville， KY）开发了一种长期植入式反搏装置（CPD），用于治疗可能对较温和形式的心脏辅助有反应的心力衰竭（HF）患者。CPD为32ml行程，无阀气动驱动的血囊，单管流入/流出。这个囊符合人体工程学，与“起搏器口袋”相吻合，移植物通过与锁骨下动脉的吻合连接到动脉系统。CPD可以通过一个标准的临床气动驱动控制台（iPulse）或一个小型的、可穿戴的气动驱动器（正在开发中）来操作，该驱动器通过经皮气管连接到囊，并定时到ECG。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，在大型动物模型（n=10）中，32ml CPD的血流动力学疗效与标准的市售40ml IABP相当，证明了其可行性。在这个II期研究中，CPD系统的可植入组件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)完成工程开发和外科手术，(2)证明可靠性和血液相容性，(3)证明CPD系统可植入部件的长期安全性和生物相容性来实现。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。拟议的研究利用了SCR， Inc的开发工作和Abiomed （Danvers， MA）的制造和商业化资源。这一伙伴关系将由犹太医院（路易斯维尔，肯塔基州）和基督医学中心（橡树草坪，伊利诺伊州）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指导。我们的长期目标是成功地将CPD作为一种可行的长期治疗方法，用于治疗晚期NYHA III级和早期NYHA IV级HF患者，以恢复他们的生活质量并促进心肌恢复。PUBLIC HEALTH RELEVANCE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，并使患者完全活动。

DESCRIPTION (provided by applicant): SCR, Inc. (Louisville, KY) has developed a long-term implantable counterpulsation device (CPD) to treat heart failure (HF) patients who may be responsive to a milder form of cardiac assist. The CPD is 32-ml stroke volume, valveless pneumatically-driven blood sac with a single inflow/outflow cannula. The sac fits ergonomically in a `pacemaker pocket' and the graft is connected to the arterial system by an anastomosis to the subclavian artery. The CPD can be operated by a standard clinical pneumatic drive console (iPulse) or a small, wearable pneumatic driver (in development) connected to the sac by a percutaneous air line and timed to 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 was comparable to a standard commercially-available 40-ml IABP in a large animal model (n=10) demonstrating feasibility. In this phase II study, the development and testing of the implantable components of the CPD system will be completed to support a future FDA submission. This objective will be accomplished by (1) completing engineering development and surgical procedure, (2) demonstrating reliability and hemocompatability, and (3) demonstrating long-term safety and biocompatibility of the implantable components of the CPD system. 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 proposed study leverages the development work of SCR, Inc and manufacturing and commercialization resources of Abiomed (Danvers, MA). This partnership will be guided by an innovative group of physicians at Jewish Hospital (Louisville, KY) and Advocate Christ Medical Center (Oak Lawn, IL) 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 as a viable long-term therapy to treat late NYHA class III and early NYHA class IV HF patients to restore their quality of life and promote myocardial recovery. PUBLIC HEALTH RELEVANCE 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 enables complete patient mobility.