Advanced heart failure represents the final stages of heart failure, where the heart’s ability to pump blood effectively is severely compromised. This condition often results from underlying health issues that damage the heart muscle, such as coronary artery disease, high blood pressure, or prior heart attacks. Proper management is essential for improving survival rates and enhancing the quality of life for patients with advanced heart failure. Now, an innovative ventricular assist device designed to augment blood flow can reduce the occurrence of adverse events associated with advanced heart failure treatment, enhance patient comfort, and minimize complications, all while prioritizing patient well-being.

The BrioVAD System, developed by BrioHealth Solutions (Burlington, MA, USA), is a full-support, durable ventricular assist device that consists of an implantable BrioVAD Pump and external components. It is designed to provide long-term support for patients with heart failure. The BrioVAD Pump features a unique magnetic bearing design that allows for a smaller pump size while incorporating a larger impeller compared to the only FDA-approved durable ventricular assist device currently available. This smaller pump may lead to reduced surgical invasiveness. Moreover, the BrioVAD Pump features an innovative driveline design that connects the pump to the external components, resulting in a thinner, more flexible driveline, which could help reduce infections related to the driveline.

The combination of the BrioVAD Pump’s magnetic bearing structure and large diameter impeller enhances the design of the blood flow pathway inside the pump. This advanced pathway design is expected to improve the device’s hemocompatibility and hemodynamics, which may reduce the risk of serious complications. The external components of the BrioVAD System, which patients wear, have been streamlined to just two components, offering a more convenient and user-friendly experience, ultimately improving the patient's quality of life. BrioHealth Solutions has enrolled its first U.S. patients in the INNOVATE Trial for the BrioVAD System. This prospective, randomized, controlled, multi-center, non-blinded study aims to assess the safety and effectiveness of the BrioVAD System in treating advanced, refractory left ventricular heart failure.

“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.” 

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