BURLINGTON, Mass.– BrioHealth Solutions, Inc., a developer of world-leading technology in ventricular assist systems, announced today it has enrolled its first patients in the U.S. for the INNOVATE Trial of the BrioVAD® System.
“We are thrilled to kick off the INNOVATE trial, following a phenomenal journey of innovation, engineering, and quality refinement to bring the BrioVAD System to life,” said Chen Chen, Ph.D., Chief Executive Officer of BrioHealth Solutions. “Despite advancements in ventricular assist devices, there remains a pressing need for improved device performance and patient outcomes, and BrioHealth is committed to addressing this gap. It is also incredibly rewarding to see the enthusiasm from our participating centers in advancing heart failure treatment through this study.”
BrioHealth has focused on developing its proprietary BrioVAD technology since 2008. The BrioVAD System features the innovative BrioVAD Pump, a fully magnetically suspended blood pump, paired with uniquely engineered external components aimed at reducing adverse events and enhancing patients’ quality of life. More than 350 patients outside the U.S. have been treated with a ventricular assist system that incorporates the BrioVAD Pump.*
The INNOVATE trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study designed to evaluate the safety and effectiveness of the BrioVAD System for treating advanced, refractory left ventricular heart failure.
“Patients with advanced heart failure have limited options when it comes to treatment, with currently just one LVAD system available in the U.S.,” said Francis D. Pagani, M.D., Ph.D., the Otto Gago, M.D., Professor of Cardiac Surgery at University of Michigan Medical School and the study’s National Principal Investigator. “Despite treatment advances, complications still occur among LVAD patients. The INNOVATE Trial will provide important insights on if the BrioVAD System can help reduce complications and improve quality of life for patients with advanced heart failure.”
“The initiation of the INNOVATE Trial is an important milestone in advancing treatment options for advanced heart failure patients,” said Mani Daneshmand, M.D., Andrew J. McKelvey Professor, Emory University School of Medicine and Director – Thoracic Transplant and MCS Surgery. “We are excited to learn how the BrioVAD System can make an impact in this patient population.”
