BrioHealth gets conditional FDA nod for pediatric ventricular assist device study

BrioHealth announced that it received conditional FDA approval to conduct a clinical evaluation of its ventricular assist device (VAD) in pediatric patients.

Burlington, Massachusetts–based BrioHealth develops the BrioVAD technology, a left ventricular assist device (LVAD). It features the BrioVAD pump, a fully magnetically suspended blood pump. It pairs with uniquely engineered external components aimed at reducing adverse events and enhancing patient quality of life.

BrioVAD’s magnetic bearing design achieves a smaller pump size with a larger impeller compared to Abbott’s HeartMate 3, the only FDA-approved durable ventricular assist system currently available, according to BrioHealth. The compact pump may reduce surgical invasiveness with its size.

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