Development of a Counterpulsation Therapy Device

描述（由申请人提供）： SCR，Inc.（Louisville，KY）已经开发了一种长期可植入的反搏装置（CPD），以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是32 ml每搏输出量、无阀、无瓣膜驱动的血囊，带有单流入/流出插管。囊符合人体工程学地安装在“起搏器袋”中，并且移植物通过与锁骨下动脉的吻合连接到动脉系统。CPD可通过标准临床气动驱动控制台（iPulse）或小型可穿戴气动驱动器（开发中）进行操作，该驱动器通过经皮空气管路连接到囊，并与ECG同步。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，在大型动物模型（n=10）中，32 ml CPD的血流动力学疗效与标准市售40 ml IABP相当，证明了其可行性。在本II期研究中，将完成CPD系统植入式组件的开发和测试，以支持未来的FDA申报。该目标将通过以下方式实现：（1）完成工程开发和外科手术，（2）证明可靠性和血液相容性，以及（3）证明CPD系统植入式组件的长期安全性和生物相容性。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。拟议研究利用了SCR，Inc的开发工作以及Abiomed（Danvers，MA）的生产和商业化资源。这种伙伴关系将由犹太医院（路易斯维尔，肯塔基州）和倡导基督医疗中心（橡树草坪，伊利诺伊州）的创新医生小组以及路易斯维尔大学（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引入CPD作为治疗晚期NYHA III级和早期NYHA IV级HF患者的可行长期疗法，以恢复其生活质量并促进心肌恢复。公共卫生相关部门正在开发一种长期反搏装置（CPD），用于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，使患者能够完全移动。

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.