TESTING OF IMPLANTABLE VENTRICULAR ASSIST SYSTEMS

该计划的总体目标是支持测试 集成植入式电动脑室辅助系统 (VAS)以确定临床准备情况。该计划的目标是 包括无系绳动物的体外和体内试验 由电驱动能量转换器组成的植入型系统 和一个可以支持衰竭的心室的血泵 对内科或外科治疗无反应。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协议开发、VAS 和测试设备制造，VAS性能和可靠性测试， VAS活体测试、身体研究以及报告和 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.