BURLINGTON, Mass., Dec. 22, 2025 /PRNewswire/ -- BrioHealth Solutions announces it has reached a major milestone with the 100th enrollment in the INNOVATE Trial of the BrioVAD® System, a Left Ventricular Assist Device (LVAD). The BrioVAD® System represents an innovative approach to addressing the unmet clinical needs in advanced heart failure care. It has been designed to augment blood flow, enhance patient comfort, and minimize complications, all while prioritizing patient well-being and reduce the occurrence of adverse events associated with advanced heart failure treatment, providing patients with peace of mind and the invaluable gift of more time to enjoy life.
"Reaching the 100th BrioVAD® enrollment implantation in the INNOVATE Trial is a remarkable milestone for our entire organization and, more importantly, for the patients we aim to serve," said Chen Chen, Ph.D. CEO of BrioHealth Solutions. "This achievement reflects the dedication of our clinical trial partners and the promise of the BrioVAD® System to expand meaningful treatment options for people living with advanced heart failure. We are one major step closer to transforming the standard of care for these patients."
Launched in late 2024, the INNOVATE Trial is a national research study bringing together leading heart centers to evaluate an innovative mechanical heart pump designed to help patients whose hearts can no longer pump enough blood on their own. The trial aims to evaluate the BrioVAD® System to develop more reliable and longer-lasting devices that can improve both survival and quality of life.
The BrioVAD® System represents an innovative approach to addressing the unmet clinical needs in advanced heart failure care. The BrioVAD System has been designed to augment blood flow, enhance patient comfort, and minimize complications, all while prioritizing patient well-being. It is designed to reduce the occurrence of adverse events associated with advanced heart failure treatment, providing patients with peace of mind and the invaluable gift of more time to enjoy life.
"Each successful implantation brings us closer to understanding the full potential of the BrioVAD® System and to expanding treatment possibilities for patients living with advanced heart failure. We are encouraged by the progress to date and remain committed to advancing the science that will shape the next generation of heart-failure care." 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 of the INNOVATE Trial."
The study continues to enroll participants and collect data that will help inform future therapies and potentially lead to broader access for patients in need. For more information, visit www.theinnovatetrial.com.
About BrioHealth Solutions
BrioHealth Solutions is developing the BrioVAD® System, a Left Ventricular Assist System representing a significant advance in the heart failure treatment space. The company's founding mission is a commitment to restoring, extending and enhancing the lives of patients globally by collaborating with healthcare providers to push the boundaries of what's possible and deliver the best medical technologies and solutions.
For INNOVATE Trial Study Details, visit https://clinicaltrials.gov/study/NCT06310031.
CAUTION: The BrioVAD® System is an Investigational Device limited by Federal (US) Law to use in the INNOVATE Trial.
SOURCE BrioHealth Solutions, Inc.
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