Current Status of the Gyro Centrifugal Blood Pump—Development of the Permanently Implantable Centrifugal Blood Pump as a Biventricular Assist Device (NEDO Project)

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Abstract
The New Energy and Industrial Technology Development Organization (NEDO) project was started in 1995. The goal is the development of a multipurpose, totally implantable biventricular assist device (BVAD) that can be used for any patient who suffers from severe heart failure. Our C1E3 (two-week pump) centrifugal pump, called the Gyro pump, has three design characteristics: a magnetic coupling and double pivot bearing system, an eccentric inlet port, and secondary vanes on the bottom of the impeller. The pump was miniaturized. The C1E3 evolved into the NEDO PI-601, a totally implantable centrifugal pump for BVAD. The current NEDO PI-710 pump (five-year pump) system includes a centrifugal pump with pivot bearings, a hydraulically-levitated impeller, an rpm-controlled miniaturized actuator (all-in-one actuator plus controller), an emergency clamp on the left outflow, and a Frank–Starling-type flow control. The final mass production model is now finalized, and the final animal study and two-year endurance studies are ongoing.