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.
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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.
Additionally, the pump incorporates a novel driveline design that electrically connects it to external components. This enables a thinner, more flexible driveline which could reduce driveline-associated infections. An advanced flow pump design could also improve hemocompatibility and hemodynamics, minimizing the risk of serious complications.
BrioHealth currently has BrioVAD under investigation in an existing FDA investigational device exemption (IDE) trial, INNOVATE. The company said the FDA’s green light marks an important step toward delivering options for children with advanced heart failure. It believes the compact pump may better meet the needs of pediatric patients.
The company plans to begin enrollment in the Brio4Kids U.S. clinical trial in mid-2026. It expects initial data in the fourth quarter.
Dr. Angela Lorts, professor of heart failure at Cincinnati Children’s Hospital Medical Center and a national principal investigator in the study, said:
“In pediatric heart failure, including in school-age children, the lack of durable LVAD options remains a major challenge. This represents a significant unmet need, and we are encouraged to explore the potential of the BrioVAD System through the Brio4Kids study.”
