PHASED READINESS TESTING OF IMPLANTABLE TAHS

这项计划的目的是完成对 电动完全可植入人工心脏(TAH)系统 并确定这些产品的可靠性、性能和可制造性 TAH系统是考虑NHLBI临床的先决条件 审判。 第一阶段(3年；最多四份合同)包括设计完成， 可制造性演示、动物性能测试和 承包商启动第二阶段装置的能力证明 准备就绪测试。第二阶段(4年；不到4份合同)将 为成功完成第一期工程的承包商提供支持 并被同行评为有价值的。第二阶段包括体外试验 无拴系植入型人工全髋关节的可靠性及体内动物实验 人工心脏系统。

The purpose of this program are to complete the development of electrically powered, totally implantable artificial heart (TAH) systems and establish the reliability, performance and manufacturability of these TAH systems as a prerequisite to consideration for an NHLBI Clinical Trial. Phase I (3 years; up to four contracts) comprises design completion, demonstration of manufacturability, performance testing in animals and demonstration of the contractor's capability to begin Phase II device readiness testing. Phase II (4 years; less than four contracts) will provide support for those contractors who successfully complete Phase I and are judged meritorious by peer-review. Phase II consists of in vitro reliability and in vivo animal testing of tether-free implantable total artificial heart systems.