Development of a Counterpulsation Therapy Device

描述(由申请人提供)：SCR公司(肯塔基州路易斯维尔)已经开发出一种长期植入式反搏动装置(CPD)，用于治疗对较温和形式的心脏辅助有反应的心力衰竭(HF)患者。CPD是32毫升的每搏量，无阀气动驱动的血囊，带有一个流入/流出插管。从人体工程学的角度来看，这个囊可以装在一个“起搏器口袋”里，移植物通过与锁骨下动脉的吻合与动脉系统相连。CPD可以由标准的临床气动驱动控制台(IPulse)或小型可穿戴气动驱动器(正在开发中)通过经皮空气管路连接到气囊并定时到心电进行操作。CPD在自然心脏收缩时充盈，降低心室负荷，在舒张期射血，增加心肌和末梢器官的血流灌注。在I期研究中，在大型动物模型(n=10)中，32毫升CPD的血流动力学效果与商业上可获得的标准40毫升IABP相当，证明了其可行性。在这项第二阶段研究中，CPD系统的可植入组件的开发和测试将完成，以支持未来FDA提交的文件。这一目标将通过(1)完成工程开发和外科程序，(2)证明可靠性和血液相容性，以及(3)证明CPD系统的可植入组件的长期安全性和生物兼容性来实现。一项关键的良好实验室实践(GLP)研究的结果将与一份摘要报告一起完成，以提交给食品和药物管理局(FDA)，以请求批准临床试验。拟议的研究利用了SCR，Inc.的开发工作以及Abied(马萨诸塞州丹弗斯)的制造和商业化资源。这一合作伙伴关系将由犹太医院(肯塔基州路易斯维尔)和倡导基督医疗中心(伊利诺伊州橡树草坪)的创新医生团队和路易斯维尔大学(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级心衰患者，以恢复他们的生活质量和促进心肌恢复。公共卫生相关部门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是为表面植入而开发的，无需进入胸部，使患者能够完全活动。

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.