BrioHealth Solutions has secured conditional approval from the US Food and Drug Administration (FDA) to initiate a clinical trial of its BrioVAD system in children diagnosed with advanced heart failure.
The Brio4Kids trial will proceed under the company’s existing investigational device exemption (IDE), previously established for the INNOVATE trial.
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Operating in China, Europe, and the US, BrioHealth Solutions is developing the BrioVAD system as a left ventricular assist device (LVAD) intended for heart failure patients.
Enrolment for the US-based trial is scheduled to start in mid-2026, with initial results expected in the fourth quarter.
The BrioVAD system features a compact pump, a thin driveline and lightweight construction, and has been developed to address existing gaps in heart failure treatment for younger patients.
Cincinnati Children’s Hospital Medical Center heart failure professor and the study’s national principal investigator Dr Angela Lorts said: “In paediatric 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.”
BrioHealth Solutions CEO Chen Chen said: “This is another important milestone in our journey to becoming a global leader in innovation and delivering best-in-class service in our field.”
The company plans to maintain its collaboration with clinical investigators, regulatory authorities and healthcare partners as the Brio4Kids study advances.
BrioHealth Solutions aims to work with healthcare professionals and develop new medical technologies for patients on a global scale.
In November 2024, the company commenced subject enrolment in the US for the INNOVATE trial, which assessed the BrioVAD system in the treatment of refractory left ventricular heart failure.
The controlled, prospective, non-blinded, non-inferiority, multi-centre trial aimed to evaluate the effectiveness and safety of the system.
