A new clinical trial has begun in the U.S. to test the BrioVAD System, a potential alternative to the HeartMate 3 (HM3), the only durable left ventricular assist device (LVAD) currently available for advanced heart failure patients in the country. BrioVAD uses fully magnetically levitated pump technology and features designed to reduce complications and improve the overall patient experience.
The trial, named INNOVATE (Investigation of a Novel Magnetically Levitated VAD for the Treatment of Refractory Left Ventricular Heart Failure; NCT06310031), is currently assessing the safety of the device at eight medical centers, including Cleveland Clinic. Soon, the trial will also evaluate the short- and long-term effectiveness of BrioVAD compared to the HM3.
“BrioVAD could provide more options for patients needing LVAD therapy,” said Dr. Pavan Bhat, cardiologist and principal investigator for the Cleveland Clinic site of the INNOVATE trial. “Having an additional device on the market could encourage more competition and foster innovation.”
Stagnation in LVAD Development
Over the last 30 years, the LVAD field has seen significant advances, driven by competition among device manufacturers. Older, bulky pulsatile-flow devices have been replaced by the current HM3, a continuous-flow pump that is fully magnetically levitated. These improvements have led to lower stroke rates (now about 2% per year after 30 days) and greater durability of devices, with failures now being rare.
The MOMENTUM 3 trial, conducted in 2018, showed that the HM3 was superior to the HeartMate II axial continuous-flow pump. Additionally, the HeartWare centrifugal continuous-flow pump was withdrawn from the market in 2021 due to safety concerns. Since then, the HM3 has been the only commercially available LVAD in the U.S., and innovation in the field has slowed since its launch in 2017.
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