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Due to a shortage of donor heart in Japan, for end-stage congestive heart failure patients a demand to provide a better quality of life with the left ventricular assist system (LVAS) is strong. EVAHEART LAVAS uses a Japanese-made compact centrifugal pump, which can be implanted into a narrow thoracic cavity. This work has been a multi-institutional project carried out in collaboration with over 50 industrial companies in various technical disciplines, and it was financially supported mainly by a private fund as well as the Japan Science and Technology corporation (JST) fund. And the University of Pittsburgh Medical Center has contributed to the animal model evaluation since 1993. The pump flow performance was represented as head-flow (H-Q) relations, demonstrating that a blood pump flow of 8 l/min can be achieved at 100 mmHg at the pump speed of 2400 rpm. This performance should be sufficient as a clinical LVAS under most of practical conditions. The in vitro durability test was performed as a system as well as components. The results show a sufficient durability and reliability. A favorable biocompatibility with the blood contacting surface was confirmed by a series of animal experiments, which include eight long-term evaluations (90-180 days) in calves, with no serious problem such as thrombus formation or mechanical problems in recent cases. Various tests with the risk conditions have also been conducted, one of which is the hemolysis test with simulated seal defect conditions. The first clinical implantation of EVAHEART was conducted at Tokyo Women’s Medical University in May, 2005. Up to now, all three patients are in satisfactory hearth conditions.
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