A prototype implantable right ventricular assist device met initial in vitro design criteria for flow and pressure, paving the way for in vivo testing.
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Prototype meets RVAD design targets in vitro; extends preclinical development but leaves clinical translation open.
Purpose: The purpose of this new program, funded by an NHLBI Bioengineering Research Partnerships (BRP) grant, is to design, develop, and clinically evaluate an implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular failure. Methods: The initial phase of this program developed a prototype RVAD following modification of the CorAide™ left ventricular assist device. The pump flow was measured in various afterload and pump speed conditions in a mock circulatory loop. Results: The nominal design point of 4 L/min and 40 mm Hg pressure rise was achieved at 2,500 rpm with a power consumption of approximately 3.5 watts. The minimum condition of 2 L/min and 20 mm Hg and the maximum condition of 6 L/min and 60 mm Hg were met at 1,800 rpm and 3,200 rpm, respectively. Conclusion: The initial in vitro testing met the design criteria of the new, implantable CorAide RVAD. Initial in vivo testing is underway, which will be followed by pre-clinical readiness testing and a pilot clinical trial in this 5-year program.
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Fukamachi et al. (2005) studied this question.
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