Abstract
The EVAHEART was developed by Sun Medical Technology Research Corporation (Nagano Japan) as an implantable left ventricular assist device and it was approved in 2010 by the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for bridge to heart transplantation (BTT). CE Marking was also approved in 2012 and it is under IDE clinical trial in the U.S.A. The pump features are: high pump performance (over 10L/min/100mmHg), low share stress, low hemolysis rate (NIH 0.005g/100L), and excellent anti-thrombogenicity. Unique flat PQ curve pump performance generates superior pulsatile and high peak flow even with advanced heart failure. The EVAHEART has been implanted more than 120 patients, more than 750 days median support duration in Japan with excellent long-term survival rate; 89.8% for 1 year and 83.2% for 2 years. The clinical outcome shows excellent low risk free rate; 95.2% for 3 years GI bleeding free, 98.0% for 3 years Hemolysis free, less than 1 % pump failure exchange and superior low vWF multimer degradation. Purpose of this research is to develop a miniaturized EVAHEART, so called EVA Kai, to fit small patients with identical support capacity with current EVAHEART. The core technology, such as Impeller design, Pump chamber design, Blood contact surface anticoagulation coating (MPC coating), hydro-dynamic bearing, Mechanical seal and CS system are inherited from current EVAHERT to EVA Kai. The inflow cannula and the outflow graft are compatible. A newly designed small diameter and flexible driveline is equipped. A small and high power drive motor is also developed and it is compatible with current controller. Pump displacement volume is 97.3 mL which is 26.3% smaller than current EVAHEART. Drive line diameter is 7.5mm which is 36.7% reduction. The pump was fabricated titanium, the pump weight was 262 g which is 37.6 % lighter including a newly developed brushless DC motor. Four animal studies with endpoint POD 60 were successfully conducted under GLP at NCVC. At the autopsy, there was no thrombus on the pump surface, and no major thromboemboli in organs except very few small renal infarct. System durability test is conducting for more than six months and electrical safety test and EMC test had successfully been conducted. The miniaturized EVAHEART has been successfully developed and animal studies show excellent result.
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