BrioHealth Commences INNOVATE Trial of BrioVAD System for Advanced Heart Failure

November 25, 2024—BrioHealth Solutions, Inc. announced it has enrolled the first patients in the INNOVATE trial of the company’s BrioVAD left ventricular assist device (LVAD) in the United States.

The INNOVATE trial is a prospective, nonblinded, randomized controlled, multicenter, noninferiority study. It is designed to evaluate the safety and effectiveness of the BrioVAD system for treating advanced, refractory left ventricular heart failure. The trial will enroll patients for both short-term and long-term mechanical circulatory support indications, noted the company.

Francis D. Pagani, MD, serves as the study’s National Principal Investigator. Dr. Pagani is the Otto Gago, MD, Professor of Cardiac Surgery at University of Michigan Medical School in Ann Arbor, Michigan.

“Patients with advanced heart failure have limited options when it comes to treatment, with currently just one LVAD system available in the United States,” commented Dr. Pagani in the BrioHealth press release. “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.”

Mani Daneshmand, MD, added, “The initiation of the INNOVATE trial is an important milestone in advancing treatment options for advanced heart failure patients. We are excited to learn how the BrioVAD system can make an impact in this patient population.” Dr. Daneshmand is Andrew J. McKelvey Professor at Emory University School of Medicine and Director of Thoracic Transplant and Mechanical Circulatory Support Surgery at Emory Healthcare in Atlanta, Georgia.

In the press release, BrioHealth stated it has been developing the BrioVAD technology since 2008. The full-support, durable BrioVAD system features the BrioVAD pump, a fully magnetically suspended blood pump, paired with external components aimed at reducing adverse events and enhancing patient quality of life. More than 350 patients outside the United States have been treated with a ventricular assist system that incorporates the BrioVAD pump, noted the company.

The BrioVAD system is an investigational device limited by Federal law to use in the INNOVATE trial, advised the company.