Motomura Tadashi, Okubo Hisashi, Oda Takeshi, Ogawa Daisuke, Okahisa Toshiya, Igo Stephen, Shinohara Toshiyuki, Yamamoto Yoshiro, Noguchi Chikaya, Ishizuka Tsukasa, Okamoto Eiji, Nosé Yukihiko
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, Japan.
ASAIO J. 2006 Jul-Aug;52(4):378-85. doi: 10.1097/01.mat.0000225263.48393.93.
Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.
自1995年以来，贝勒集团一直在研发一种完全可植入的新能源产业技术开发机构（NEDO）双心室辅助装置（BVAD）系统。这个为期10年的项目于2005年3月完成，目前正在进行临床试验的准备工作。本文总结了整个为期10年的新能源产业技术开发机构项目，并描述了临床试验策略。该项目旨在实现：（1）具备全心室支持能力的双离心泵；（2）可植入小体型成年人的紧凑型系统；（3）带有经皮能量传输系统（TETS）的完全可植入系统；（4）使用寿命超过5年的耐用系统；（5）无血栓且溶血极少的系统。最终目标是完成临床前系统评估，并在不久的将来开始临床试验。体外研究表明，泵流量超过8.5升/分钟，溶血指数<0.004克/100升。泵轴承的预期寿命超过5年。迄今为止，8个泵在体内进行了超过3个月的研究，未出现并发症，包括血栓栓塞事件。8个泵的体外耐久性研究超过1年。没有机械故障或泵失效情况。正在计划进行逐步临床试验：第一步，对可穿戴式BVAD/VAD进行临床研究；第二步，在不使用TETS的情况下将BVAD/VAD植入体内；第三步，对完全可植入系统进行临床评估。新能源产业技术开发机构BVAD系统已完成临床前测试。临床试验准备工作正在进行中。
