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Several in vivo animal tests have been successfully completed at Hershey Medical Center. During the animal tests, the pump was hooked up to the calf and operated in parallel with the calf's heart. The initial animal studies demonstrated the efficacy of MiTiHeart™ LVAD with respect to surgical procedures for implanting the pump and the assessment of initial transition shock on the pump and animal, as well as form, fit and function tests. Under the second SBIR grant from NIH, a unique back up thrust bearing was designed and incorporated into the MiTiHeart™ LVAD. The hydrodynamic thrust bearing is used to prevent potential contacts under most severe transient loading conditions, for example, when the patient falls accidentally, and in case of failure of the magnetic bearing. With the hydrodynamic thrust bearing in place, catastrophic failure of the axial magnetic suspension will be prevented, thus providing a fail-safe operation. The performance of the thrust bearing was evaluated in bench tests prior to its integration into the revised pump. A chronic 200-hour implant study was completed in 2004 was successfully completed with the first prototype at the Hershey Medical Center. During the test, the pump was implanted in a calf and operated in parallel with the heart. A new prototype pump was built from Ti-6Al-4V, a titanium alloy, known for its biocompatibility. Succesful animal tests were conducted in 2005 at Hershey Medical Center for a total of 130 hours. The Third prototype of the MiTiHeart™ LVAD was recently designed and fabricated. The new prototype is 60% smaller than the 2nd Prototype. In vitro and in vivo animal tests are currently being performed in addition; long term durability testing is also planned for the next 12-18 months.
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