PHASED READINESS TESTING OF IMPLANTABLE TAHS

植入式 TAHS 的分阶段准备测试

• 批准号: 2317907
• 负责人: ROBERT T KUNG
• 金额: $ 175.81万
• 依托单位: ABIOMED, INC.
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 2000-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2317907
• 关键词: PHASED; READINESS; TESTING; IMPLANTABLE; TAHS

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.

该计划的目的是完成开发 电动、完全植入式人工心脏（TAH）系统 并建立这些产品的可靠性、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4个合同）包括设计完成， 可制造性证明、动物性能试验和 承包商开始第二阶段装置的能力证明 准备测试。 第二阶段（4年;少于4份合同）将 为成功完成第一阶段的承包商提供支持 并通过同行评审被评为有价值。 II期包括体外 无栓系植入式全髋关节置换术的可靠性和体内动物试验 人工心脏系统