W021003 Development and Productization of Ventricular Assist Device

Abstract

EVAHEARTR^[○!R] is tin implantable ventricular assist device developed by Sun Medical Technology Research Corp. EVAHEARTR^[○!R] consists of a small, light-weight, and high performance centrifugal blood pump. The unique Cool Seal System ensures exceptional durability and improved hemocompatibility while assisting physiological blood flow. In Japan, EVAHEARTR^[○!R] received the approval for manufacturing and marketing of medical devices in 2010 and its sales began in 2011. Neither the blood pump failure nor the blood pump replacement has been reported as of today.