Extended in Vivo Evaluation of the Implantable Magnetic-Hydrodynamic
Suspension Ventricular Assist Device
XU Jian1, FAN Qinglin1, ZHU Chenqi1, ZHAO Tingbiao1, LIU Xiaocheng2, LIU Zhigang2, CHEN Tienan2, ZHANG Jiemin2
1.RocketHeart Technology Co., Ltd., Tianjin 300457, China;
2.Department of Cardiac Surgery, TEDA International Cardiovascular Hospital, Tianjin 300457, China
Abstract:Objective To verify the safety and reliability of implantable magnetic-hydrodynamic suspension ventricular assist device in longlived
left ventricular assisted animals. Methods The appropriate animals were selected appropriately to establish standard operating procedures
(SOPs) for animal care during preoperative, intraoperative, and postoperative operation according to the relevant laws and regulations at home
and abroad, as well as professional experience. An animal welfare system was established based on 3R (refinement, reduction and replacement)
principle. Results The left ventricular assist device was implanted in an ovine (n=6) model to achieve a long-term healthy survival for
more than 95 days. The implantable magnetic-hydrodynamic suspension ventricular assist devices were successfully implanted and showed
excellent support with no mechanical failures throughout the implant period. Conclusion The experimental animals have been rationally
selected, and the surgical and nursing SOPs are standardized. The implanted animals at stable physiological status show that the implantable
magnetic-hydrodynamic suspension ventricular assist device with good performance have reached the pre-clinical application level.
许剑1,范庆麟1,朱尘琪1,赵廷彪1,刘晓程2,刘志刚2,陈铁男2,张杰民2. 植入式磁液悬浮心室辅助装置的动物长期体内评价研究[J]. 中国医疗设备, 2018, 33(9): 19-22.
XU Jian1, FAN Qinglin1, ZHU Chenqi1, ZHAO Tingbiao1, LIU Xiaocheng2, LIU Zhigang2, CHEN Tienan2, ZHANG Jiemin2. Extended in Vivo Evaluation of the Implantable Magnetic-Hydrodynamic
Suspension Ventricular Assist Device. China Medical Devices, 2018, 33(9): 19-22.