2018 Volume Annual56 Issue Abstract Pages S9
EVAHEART is a highly-pulsed, low shear rate, centrifugal LVAD with excellent long term reliability. EVAHEAR 2 is greatly reduced in size and weight by laser welding and miniaturized motor. The diameter of the drive cable was reduced by 36.7% of the sectional area ratio. The lubrication condition of the mechanical seal was improved by surface modification, the rotational resistance remarkably stabilized. EVAHEART 2 was approved by PMDA in November 2017. Regarding overcoming of cerebrovascular disorder, we developed a tip less inflow cannula which can prevent blood flow stagnation completely. About overseas deployment: In China, EVAHEART was approved as "innovative medical device" in 2015, and clinical trial started in January 2018. Regarding the United States, clinical trial with EVAHEART 2 + tip less inflow cannula is approved by the FDA in February 2018, and a feasibility study is scheduled to be started at six institutions in sequence.
