ATLANTA – Emory University Healthcare has achieved a significant milestone by becoming the first medical team in the United States to successfully implant a new experimental heart pump, known as the BrioVAD System, designed to assist patients suffering from heart failure.
The procedure took place on November 18 and marks the beginning of the INNOVATE clinical trial, which aims to evaluate the safety and effectiveness of this innovative ventricular assist device (VAD). The BrioVAD System, developed by BrioHealth Solutions, received FDA approval for clinical trials earlier this year. Emory is one of several leading medical institutions participating in this important study, alongside Cleveland Clinic, Duke University, and the University of Chicago.
Dr. Mani Daneshmand, a cardiothoracic surgeon and director of Heart and Lung Transplant at Emory, led the surgical team.
He emphasized the significance of this advancement in heart failure treatment. “The BrioVAD is a promising heart assist pump designed with a focus on patient safety and quality of life,” he stated. “With this study, we continue our long history of innovation in providing compassionate care.”
The BrioVAD System features a magnetically levitated pump that aims to reduce the risk of complications such as stroke and blood clots.
This new device is believed to enhance patient outcomes significantly compared to existing VAD technologies. Dr. Daneshmand noted that the device is designed to be more biocompatible and addresses many issues seen with previous models.
While the BrioVAD System is not yet FDA-approved for general use, preliminary research suggests it could allow patients to live comfortably for extended periods. The hope is that it can serve as either a long-term solution for those who cannot receive transplants or as a bridge to transplantation for patients awaiting surgery.
The INNOVATE trial will assess both short-term and long-term outcomes for patients using the BrioVAD System over a period of up to 24 months. This study aims to provide critical data on how well the device performs in real-world settings.
BrioHealth Solutions has been developing this technology since 2008 and has already treated over 300 patients outside the United States with devices incorporating similar technology. The company’s CEO, Chen Chen, expressed excitement about launching the trial and highlighted the ongoing need for improved heart failure treatments.
As heart failure remains a leading cause of death among patients in the U.S., advancements like the BrioVAD System represent hope for better management and improved quality of life for those affected by this serious condition.
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