EVAHEART is an implantable centrifugal blood pump for long-term circulatory assistance. Japanese clinical feasibility study has been conducted since May 2005. Inclusion criteria were; end-stage irreversible heart failure of NYHA class IV, eligible for heart transplantation, inotropic dependent, age from 20 to 60 years old. Three dilated cardiomyopathy patients have been enrolled for feasibility study and supported for 821 +, 761 +, 757 + days, respectively, and on going. Though the pump speed was fixed at constant speed, the pump flow rate was complete pulsatile pattern. NYHA class improved to I. All three patients discharged from hospitals on device, enjoy daily life at home. Furthermore, the first patient came back to work. Pivotal study (4 clinical sites, 16 subjects) started on June 2006. Nine patients were enrolled as of today. One patient died due to cerebral bleeding on POD 62. Eight patients have been supported for 405+, 332+, 325+, 269+, 155+, 148+, 130+, 8+ days, respectively (on going). EVAHEART provided complete pulsatile high flow circulatory support and satisfactory results have been obtained in Japanese clinical study.
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