BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

BrioHealth Solutions has received FDA Investigational Device Exemption (IDE) approval to start enrollment in its Innovate clinical trial assessing the effectiveness and safety of the BioVAD System for treating refractory left ventricular heart failure.

The BrioVAD System is a magnetically levitated ventricular assist device designed to treat patients with advanced heart failure, offering both temporary and long-term support. It consists of a novel hemocompatible blood pump with a fully magnetically levitated rotor and two small, lightweight, patient-worn components.

"Achieving this stage of FDA approval for the Innovate trial marks an important step in providing more options to clinicians and patients seeking advanced heart failure therapies," said Francis D. Pagani, MD, PhD, the Otto Gago MD Endowed professor in cardiac surgery at the University of Michigan and study's national principal investigator, in the press release announcing the IDE approval. "The clinical evaluation of the BrioVAD System is a significant leap forward for the entire field of heart failure. Countless patients go untreated each year and continue to suffer with this seriously debilitating condition.”

The company has initiated clinical site start-up activities in the US in response to the approval. In the study, the device will be evaluated relative to technology that has already been FDA approved.

"We are excited to have achieved this crucial milestone,” said Chen Chen, PhD CEO of BrioHealth Solutions, in the release. “Our goal is to deliver patient-centered solutions for advanced heart failure patients and their families. The innovative BrioVAD System, with its compact pump designed for hemocompatibility along with small, lightweight peripherals, has been engineered to restore patients back to active lifestyles."