AXIAL FLOW BLOOD PUMP WITH SIMPLIFIED BEARINGS--PHASE II

该第二阶段项目包括开发和临床前鉴定 左心室辅助系统(LVAS)的特点是一个微型 带有简化(例如，浸血)轴承的轴流血泵。在……里面 第一阶段获得了令人信服的证据，证明了 这种新型轴流泵。特别是在体内的几个结果 测试，包括为期2个月的一次和一次正在进行的实验 接近5个月，表明泵在血液中运行的潜力 在与临床移植桥(BTT)一致的时间段内 申请。现在在第二阶段的目标是完成 并进行充分的体外和动物试验以记录 它的总体安全性和性能，预计将进行临床试验 适用于最长90天的BTT申请。 除泵外，LVAS还包括流入/流出套管和 外部磨损的部件，例如主电池、备用电池和 泵控制器，提供功率和闭环速度控制 植入式泵。一根小直径的经皮钢丝连接着植入的 将泵连接到外部控制器。如果最终成功，这个新的LVAS 将比产品简单得多、体积小得多、成本更低 今天可用于临床使用。 拟议的商业应用：移植的桥梁应用 将是第一次使用这种类型的左冠状动脉腔内支架来治疗心力衰竭 病人。除了过渡到移植的应用程序外，LVAS还将 有资格作为移植的替代品使用。后者 应用程序具有非常大的商业潜力，并且是最 对这款设备意义重大。

This Phase II project involves development and pre-clinical qualification of a left ventricular assist system (LVAS) that features a miniature axial flow blood pump with simplified (e.g., blood-immersed) bearings. In Phase I convincing evidence was obtained demonstrating the feasibility of this new axial flow pump. In particular the results of several in vivo tests, including one of 2-months duration and one ongoing experiment approaching 5 months, indicate the pump's potential to operate in blood for periods of time consistent with clinical bridge-to-transplant (BTT) applications. Now in Phase II the goals are to complete development of this LVAS and conduct sufficient in vitro and animal testing to document its overall safety and performance, in anticipation of a clinical trial for BTT applications lasting up to 90 days. In addition to the pump, the LVAS consists of inflow/outflow cannulae and externally worn components, e.g., primary battery, back-up battery, and pump controller, which provide power and closed-loop speed control of the implanted pump. A small diameter percutaneous wire connects the implanted pump to the external controller. If ultimately successful, this new LVAS would be vastly simpler, smaller, and less costly than the products available today for clinical use. PROPOSED COMMERCIAL APPLICATION: The bridge-to-transplant application would only be the first use of this type of LVAS to treat heart failure patients. Beyond bridge-to-transplant applications, the LVAS would then be qualIfied for use as an alternative-to-transplant. This latter application has a very large commercial potential and is the most significant for this device.