TESTING OF IMPLANTABLE VENTRICULAR ASSIST SYSTEMS

该计划的总体目标是支持测试 集成植入式电动心室辅助系统 (VAS)建立临床准备状态 该计划的目标 包括在动物体内和体外测试无栓系的 由电致动能量转换器组成的可植入系统 以及一个可以支持衰竭心室的血泵 对药物或手术治疗无反应。它包括演示 可接受的系统性能、可靠性和主机对 系统 这项工作具体包括测试方案开发、VAS 和测试设备制造，VAS性能和可靠性测试， VAS体内试验、尸体研究和报告的编写， 技术数据。

The overall objective of this program is to support the testing of integrated implantable electrically powered ventricular assist systems (VAS) to establish clinical readiness. The objectives of this program include the in vitro and in vivo testing in animals of a tether-free implantable system consisting of an electrically actuated energy converter and a blood pump that can support the failing ventricle which is unresponsive to medical or surgical therapy. It includes the demonstration of acceptable system performance, reliability, and host response to the system. The effort specifically includes test protocol development, VAS and test equipment fabrication, VAS performance and reliability testing, VAS in vivo testing, cadaver studies, and the preparation of reports and technical data.