Key result
The DexAide right ventricular assist device demonstrated successful performance in two 3-month in vivo calf experiments and completed an 18-month in vitro endurance test.
The DexAide RVAD demonstrated successful in vitro endurance and in vivo anatomical fit and function in calf models, supporting further preclinical development toward clinical trials.
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Supports further preclinical DexAide RVAD development in calves; leaves open clinical translation pending additional studies.
The DexAide right ventricular assist device (RVAD) is a magnetically and hydrodynamically levitated implantable centrifugal pump. Recent progress includes 1) redesign of the inflow/outflow conduits, which yielded two successful 3-month experiments, 2) development of alternative journal bearing materials, and 3) completion of an 18-month duration of in vitro endurance testing. Verification testing of the RVAD electronics has been completed, and a prototype biventricular assist device (BVAD) system has been tested. Acute DexAide/CorAide BVAD implantations via median sternotomy in two calves documented BVAD control algorithms and anatomical fit. A drug-induced chronic calf heart failure model, currently under development in our laboratory, resulted in a successful BVAD implantation in a calf with heart failure. Our future plans are to complete in vitro and in vivo validation of alternative bearing materials, perform preclinical DexAide in vivo and in vitro reliability studies, and obtain Food and Drug Administration (FDA) approval for an Investigational Device Exemption to conduct a clinical pilot study. In conclusion, two successful 3 month in vivo experiments and an 18-month in vitro endurance test were completed. After final bearing material selection, the DexAide design will be "frozen" so that preclinical systems can be manufactured. BVAD experiments using a chronic heart failure model are in progress.
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Fukamachi et al. (2008) studied Heart failure (n=3). DexAide right ventricular assist device was evaluated on Device performance and endurance. The DexAide right ventricular assist device demonstrated successful performance in two 3-month in vivo calf experiments and completed an 18-month in vitro endurance test.
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