The Lotus aortic valve replacement system is a fully repositionable TAVR device designed to minimize paravalvular regurgitation, currently under investigation in the REPRISE clinical trial program.
Lotus TAVR remains investigational per review; leaves open its role versus approved devices pending REPRISE outcomes.
As a result of recent randomised controlled trials and registry observations, transcatheter aortic valve replacement (TAVR) enjoys growing appeal for the treatment of patients at high or extreme risk from surgical aortic valve replacement. However, the current technologies and techniques have important limitations, including risk of stroke, vascular complications and paravalvular aortic regurgitation, which may in turn influence survival. While careful patient selection and screening may improve outcomes, new valve designs and iterations are required. The Lotus aortic valve replacement system is a new fully repositionable device designed to facilitate more precise delivery and minimise paravalvular regurgitation. The safety and efficacy of the Lotus valve are being studied systematically in the REPRISE clinical trial programme.
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Meredith et al. (2012) studied this question.
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