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The MiTiHeart® LVAD has been extensively evaluated in both in vitro and in vivo animal studies. The LVAD system has been successfully subjected to more than 5,000 hours of in vitro testing and 2,000 hours of animal implant testing. The latest MiTiHeart® LVAD system is compact, efficient and capable of long-term stable operation in vitro and in vivo. A total input power of 6 W was required at a design point of 4,100 rpm while pumping 5 L/min against 100 mmHg. This is among the lowest power reported by magnetically levitated LVADs found in literature. In Vitro testing showed low hemolysis under non-pulsatile and pulsatile conditions. NIH values are among the lowest reported in literature. Long-term durability testing has been demonstrated for 63 days of continuous operation while submerged in saline. Two successful chronic implant studies were performed. In both studies, the MiTiHeart® LVAD operated as expected with no device related complications. Recent test results will allow the MiTiHeart® LVAD to move forward with FDA IDE application, following additional testing that is currently underway.

 

MiTi Developments, Volume 28, Pre-Clinical Evaluation of the MiTiHeart® LVAD

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*Beginning in 2012, for each animal test MiTiHeart is involved in, a donation is made to Heifer International.

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Pre-Clinical Testing*

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