BrioHealth Solutions Begins Patient Recruitment for the INNOVATE Study of the BrioVAD® System in Advanced Heart Failure
News

BrioHealth Solutions Begins Patient Recruitment for the INNOVATE Study of the BrioVAD® System in Advanced Heart Failure

Posted on by Amelia Pressman

BrioHealth Solutions begins patient recruitment for BrioVAD’s INNOVATE trial® Advanced Heart Failure System

INNOVATE study to evaluate the safety and effectiveness of the company’s investigational left ventricular assist device compared to the standard delivery device LVAD

BrioHealth Solutions, Inc., a developer of world-leading ventricular assist device technology, today announced that it has enrolled its first U.S. patients in the INNOVATE trial of BrioVAD® System.

This press release contains multimedia. The full press release can be found here: https://www.businesswire.com/news/home/20241120115022/en/

The BrioVAD® System features the innovative BrioVAD pump, a fully magnetically suspended blood pump paired with uniquely designed external components aimed at reducing adverse events and improving patients’ quality of life. (Graphic: Business Wire)

“We are very pleased to launch the INNOVATE test after a phenomenal journey of innovation, engineering and quality improvement to bring the BrioVAD system to life,” he said Chen Chen, Ph.D.,Chief Executive Officer of BrioHealth Solutions. “Despite advances in ventricular assist devices, there remains an urgent need to improve device performance and patient outcomes, and BrioHealth is committed to filling this gap.” It is also incredibly rewarding to see the enthusiasm our participating centers bring to the treatment of Advancing heart failure through this study.”

BrioHealth has focused on developing its proprietary BrioVAD technology since 2008. The BrioVAD system features the innovative BrioVAD pump, a fully magnetically suspended blood pump paired with uniquely designed external components aimed at reducing adverse events and improving patients’ quality of life. More than 350 patients outside the United States have been treated with a ventricular assist device that includes the BrioVAD pump.*

The INNOVATE study is a prospective, non-blinded, randomized, controlled, multicenter, non-inferiority study to evaluate the safety and effectiveness of the BrioVAD system for the treatment of advanced, refractory left ventricular heart failure.

“Patients with advanced heart failure have limited treatment options as only one LVAD system is currently available in the United States,” he said Francis D. Pagani, M.D., Ph.D., Otto Gago, M.D., professor of cardiac surgery at the University of Michigan Medical School and national principal investigator of the study. “Despite advances in treatment, complications still occur in LVAD patients. The INNOVATE study will provide important insights into whether the BrioVAD system can help reduce complications and improve the quality of life of patients with advanced heart failure.”

“The start of the INNOVATE study is an important milestone in the further development of treatment options for patients with advanced heart failure.”said Mani DaneshmandMD, Andrew J. McKelvey Professor, Emory University School of Medicine and Director – Thoracic Transplantation and MCS Surgery. “We are excited to see what impact the BrioVAD system can have on this patient population.”

About BrioHealth Solutions

BrioHealth Solutions is a medical device company headquartered in Burlington, Massachusetts. The company develops, manufactures and markets devices for the treatment of patients with advanced and persistent heart failure. BrioHealth Solutions is committed to restoring, extending and improving the lives of patients worldwide by collaborating with healthcare providers to push the boundaries of what is possible and provide the best medical technologies available. For more information, please visit the Company’s website at www.briohealthsolutions.com and follow the Company on LinkedIn and Twitter/X.

About the BrioVAD system

The BrioVAD System is a durable, full-assist ventricular assist device consisting of an implantable BrioVAD pump and external components designed to provide long-term support for patients with heart failure. The BrioVAD pump features an innovative magnetic bearing design that achieves a smaller pump size with a larger impeller compared to the only FDA-cleared durable ventricular assist device currently available. The compact pump can potentially reduce surgical invasiveness. Additionally, the BrioVAD pump features a novel drivetrain design that electrically connects the pump to the external components, resulting in a significantly thinner and more flexible drivetrain, which can potentially reduce driveline-related infections.

The combination of the BrioVAD pump’s magnetic bearing design and large diameter impeller enables significant innovation in the design of the blood flow path within the pump. This advanced flow path design has the potential to improve device hemocompatibility and hemodynamics and minimize the risk of serious complications.

The external, patient-worn components of the BrioVAD system have several unique design features, requiring only two components, which can improve the user experience and patient quality of life.

The BrioVAD system is a research device whose use in the INNOVATE study is restricted by federal law.

About the INNOVATE study

The INNOVATE study is a prospective, non-blinded, randomized, controlled trial enrolling patients for both short- and long-term mechanical circulatory support indications. For more information, visit www.theinnovatetrial.com

About advanced heart failure

Heart failure is a chronic, progressive disease in which the heart muscle loses its ability to pump enough oxygen-rich blood throughout the body. Advanced heart failure is a serious condition that refers to the later stages of the disease and occurs in approximately 650,000, or 10 percent, of people with heart failure in the United States1 Approximately 75% of heart failure patients die within five years of diagnosis.2 As heart failure progresses and the patient enters later stages of the disease, the use of mechanical circulatory support devices such as LVADs may be necessary to help the heart pump blood effectively throughout the body and allow the patient to participate in daily activities.

1American Heart Association (heart.org)

2Severino P, Mather PJ, Pucci M, et al. (2019). Advanced heart failure and end-stage heart failure: is there a difference? Diagnostics (Basel), 9(4), 170.

*The BrioVAD pump is the same pump used in the CH-VAD system.

Jessica Volchok

Merryman Communications

310-849-7985

[email protected]

Justin Callaway

BrioHealth solutions

[email protected]

View source version on businesswire.com: https://www.businesswire.com/news/home/20241120115022/en/

Leave a Reply

Your email address will not be published. Required fields are marked *