BrioHealth Solutions, Inc. has announced the enrollment of the first patients in the U.S. for the INNOVATE Trial, which will evaluate the BrioVAD System for treating advanced, refractory left ventricular heart failure. The trial is designed to assess the safety and effectiveness of the BrioVAD System compared to the current standard of care LVADs.
Addressing Unmet Needs in Heart Failure Treatment
Chen Chen, Ph.D., CEO of BrioHealth Solutions, emphasized the need for improved device performance and patient outcomes in ventricular assist devices. "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," Chen stated.
INNOVATE Trial Design and Objectives
The INNOVATE trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study. It aims to evaluate the BrioVAD System's ability to treat advanced, refractory left ventricular heart failure effectively and safely. The BrioVAD System incorporates the BrioVAD Pump, a fully magnetically suspended blood pump, along with uniquely engineered external components designed to reduce adverse events and improve patients’ quality of life. Over 350 patients outside the U.S. have already been treated with ventricular assist systems using the BrioVAD Pump.
Expert Perspectives on the BrioVAD System
Francis D. Pagani, M.D., Ph.D., the National Principal Investigator for the study and a professor at the University of Michigan Medical School, noted the limited treatment options available for advanced heart failure patients. "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 Dr. Pagani. He added that the INNOVATE Trial would provide crucial insights into whether the BrioVAD System can reduce complications and enhance the quality of life for these patients.
Mani Daneshmand, M.D., Professor at Emory University School of Medicine, also expressed enthusiasm about the trial's potential impact. "The initiation of the INNOVATE Trial is an important milestone in advancing treatment options for advanced heart failure patients," said Dr. Daneshmand.
BrioVAD System: Key Features
The BrioVAD System is designed for long-term support for heart failure patients. The BrioVAD Pump features a magnetic bearing design, facilitating a smaller pump size with a larger impeller compared to existing FDA-approved LVADs. This compact design may reduce surgical invasiveness. Additionally, the system incorporates a novel driveline design, resulting in a thinner and more flexible driveline, potentially reducing driveline-associated infections. The external components are designed to enhance user experience and patient quality of life, consisting of only two components.
Addressing Advanced Heart Failure
Advanced heart failure affects approximately 650,000 people in the U.S., representing about 10% of all heart failure patients. Approximately 75% of heart failure patients die within five years of diagnosis. Mechanical circulatory support devices like LVADs can help the heart pump blood more effectively, enabling patients to participate in daily activities.
