CENTRIFUGAL CIRCULATORY ASSIST DEVICE

拟议研究的长期目标是开发， 获得IDE资格、进行临床试验、获得PMA并投放市场 一种可植入的临时心室辅助系统(VAS)，它是 在尺寸、外科手术方面优于现有设备 复杂性、易用性和成本。的主要具体目标 建议的计划是开发和演示连续的 基于第一阶段结果和Nimbus赞助的交付VAS 事态的发展。该装置的目标是临时脑室 协助市场。 这些目标将通过制造显影器件来实现， 进行性能、流动显示和溶血测试 进行急性和慢性体内试验。体内测试将 评估设备-主机的溶血和血栓形成特性 互动，并展示该设备是否适合 术语用法。实验室对该设备的耐久性测试也将 完成了。 这项技术创新涉及一项紧凑型汽车的示范 持续输送VAS解决轴封和血栓 以前这种类型的设备的问题特征，以及 保留所需的性能和溶血特性。这个 商业潜力在于它比目前可用的更优越。 可植入装置的大小、外科手术的复杂性 植入性、易用性和成本。

The long-term objective of the proposed research is to develop, qualify for an IDE, conduct clinical trials, obtain PMA and market an implantable temporary ventricular assist system (VAS) which is superior to existing devices with respect to size, surgical complexity, ease of use and cost. The principal specific aim of the proposed program is to develop and demonstrate the continuous delivery VAS which is based on Phase I results and Nimbus sponsored developments. The device is targeted for the temporary ventricular assist market. The goals will be achieved by fabricating development devices, conducting performance, flow visualization and hemolysis tests and conducting acute and chronic in vivo tests. The in vivo tests will evaluate hemolysis and thrombogenicity characteristics, device-host interactions and demonstrate suitability of the device for moderate term use. Laboratory endurance testing of the device will also be accomplished. The technological innovation involves demonstration of a compact continuous delivery VAS which resolves shaft seal and thrombus problems characteristic of previous devices of this type and which retains required performance and hemolysis characteristics. The commercial potential lies in its superiority to currently available implantable devices with respect to size, complexity of surgical implantation, ease of use and cost.