AXIAL FLOW BLOOD PUMP WITH SIMPLIFIED BEARINGS--PHASE II

该II期项目涉及开发和临床前鉴定 左心室辅助系统（LVAS）， 具有简化的（例如，血液浸入）轴承。在 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几种体内试验的结果， 测试，包括一项为期2个月的测试和一项正在进行的实验 接近5个月，表明泵在血液中运行的潜力 与临床移植桥（BTT）一致的时间段 应用.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 它的整体安全性和性能，预期临床试验 BTT应用程序持续长达90天。 除泵外，LVAS还包括流入/流出插管和 外部磨损部件，例如，主电池、备用电池，以及 泵控制器，其提供泵的功率和闭环速度控制， 植入泵。小直径经皮导丝连接植入的 泵连接到外部控制器。如果最终成功，这个新的LVAS 会比我们的产品更简单，更小，更便宜， 目前可用于临床。 拟议的商业应用：移植桥应用 这将是首次使用这种类型的LVAS治疗心力衰竭， 患者除了桥接移植应用之外，LVAS还将 有资格作为移植的替代品后一 应用程序具有非常大的商业潜力，是最 对这个装置来说意义重大。

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.