CHRONIC VAS UTILIZING AXIAL FLOW BLOOD PUMP - PHASE II

描述（改编自申请人的摘要）：该第二阶段计划将 完成基于轴向的左心室辅助系统的开发 流量泵技术 这是光轮医疗公司， 股份有限公司、匹兹堡大学医学院（UOP）， 领先的移植中心和人工心脏的临床研究者。 永久植入的轴流辅助系统最终将用于 来治疗晚期心肌病患者系统的可行性 已经在第一阶段通过三个体内实验得到证实 (1-14天）和90天的体外耐久性测试。 的磨损 轴承和密封面至少有两年的使用寿命。 在第二阶段之后，将完成足够的开发，以便开始 正式的资格认证计划，以获得FDA批准的临床试验。 在第三阶段，辅助系统将进入临床试验， 作为心脏移植的桥梁， 晚期心肌病患者。第三阶段将完成临床 轴向流动辅助系统的试验和开始商业化。 一个 预计年业务总额在1亿美元范围内， 心肌病在美国的发病率。

DESCRIPTION (Adapted from applicant's abstract):This Phase II program will complete the development of a left ventricular assist system based on axial flow pump technology. It is a collaborative effort between Nimbus Medical, Inc., and the University of Pittsburgh's School of Medicine (UOP), a leading transplant center and clinical investigator of artificial hearts. The permanently implanted axial flow assist system will ultimately be used to treat patients with terminal cardiomyopathy. Feasibility of the system has been demonstrated during Phase I through three in vivo experiments (1-14 days) and an in vitro durability test of 90 days. The wear of bearing and seal surfaces is compatible with at least two years of life. After Phase II, sufficient development will have been completed to begin a formal qualification program to gain FDA approval for clinical trials. During Phase III, the assist system will enter clinical trails for use as a bridge to cardiac transplantation and as a permanent implant to treat patients with terminal cardiomyopathy. Phase III will complete clinical trials and begin commercialization of the axial flow assist system. An annual gross business in the range of $100 million is projected based on the incidence cardiomyopathy in the United States.