BrioHealth Solutions revealed today that it has begun enrolling its initial cohort of patients in the United States for the INNOVATE clinical study of its BrioVAD system.
Hailing from Burlington, Massachusetts, BrioHealth has been developing its BrioVAD technology since 2008. This left ventricular assist device (LVAD) incorporates the BrioVAD pump, a magnetic suspension blood pump. It is complemented by distinctively designed external components intended to minimize complications and improve patient well-being.
According to BrioHealth’s statement, the BrioVAD’s magnetic bearing configuration allows for a more compact pump with a larger impeller, setting it apart from Abbott’s HeartMate 3, the sole FDA-endorsed long-term ventricular assist device presently on the market. Its reduced size may lead to less invasive surgical procedures.
Furthermore, the pump boasts an innovative driveline design that provides electrical connectivity to external parts. This results in a slimmer, more pliable driveline, potentially lowering the risk of driveline-related infections. The improved flow pump design is engineered to enhance hemocompatibility and hemodynamics, potentially reducing the occurrence of severe complications.
With over 350 patients outside the U.S. treated using a system integrating the BrioVAD pump, the INNOVATE trial is set to assess the safety and effectiveness of BrioVAD in managing advanced, resistant left ventricular heart failure.
“We’re ecstatic to launch the INNOVATE trial, a milestone achieved after an incredible journey of innovation, engineering breakthroughs, and quality advancements to develop the BrioVAD system,” commented Chen Chen, Ph.D., CEO of BrioHealth Solutions. “Even with progress in ventricular assist devices, there is an ongoing need for enhanced device performance and patient outcomes. BrioHealth is dedicated to closing this gap. Additionally, it’s immensely gratifying to witness the enthusiasm from our collaborating centers in pushing forward heart failure treatment through this trial.”