On Nov. 18, the heart failure and transplantation team at Emory University Hospital (EUH) made history, performing the first-ever surgical implantation in the United States of a brand-new type of ventricular assist device (VAD), which provides crucial care to patients with failing hearts.
An expert team led by veteran cardiothoracic surgeon Mani Daneshmand, MD, successfully implanted a novel magnetically levitated pump, a VAD that has been specifically designed for patient ease and long-term health. The BrioVAD System, made by BrioHealth Solutions Inc., was authorized by the FDA to begin clinical trials earlier this year. Emory became the first site enrolled in the trial to perform the procedure.
As part of the INNOVATE clinical trial, Emory will participate in gathering data on patient experience with the device, joined by other leading medical institutions across the country, including Cleveland Clinic Foundation, Duke University and University of Chicago.
The entry criteria for joining the study were rigorous. Emory qualified because of its high quality and extensive VAD experience. Emory has long led Metro Atlanta and the region in number and success rate of VAD implantations. Since the program began, Emory Healthcare has completed almost 1,000 VAD implants between EUH and Emory St. Joseph's Hospital.
“We’re honored to be the first implanting site in this study,” Daneshmand says. “The BrioVAD is a promising heart assist pump, designed from the ground up with focus on patient safety and quality of life. With this study, we continue our long history of innovation in pursuit of our mission to bring compassionate, quality care to every patient who arrives at our doors seeking care.”
First used in the 1960s, VADs have been an effective treatment for patients with advanced heart failure, often providing an alternative for patients who don’t qualify for a transplant — which can mean the difference between life and death.
The lifesaving device, which has evolved significantly over the decades, works by providing mechanical circulatory support and helping to pump blood from the lower chambers of the heart to the rest of the body. Because the device is almost always placed on the left side of the heart, the device is frequently referred to as an LVAD.
The BrioVAD system is composed of a “hemocompatible blood pump,” meaning that it interacts with the blood in a way that may have fewer side effects. The new VAD also includes a fully magnetically levitated rotor and two small, lightweight, patient-worn components.
“The BrioVAD shows great promise to improve on the current, excellent LVAD technology we are using every day,” says Daneshmand, who is the Andrew J. McKelvey Professor at Emory School of Medicine and Director of Thoracic Transplant and MCS Surgery.
The hope is that the new VAD may be used as life-long destination therapy, meaning that the VAD is used instead of transplant, or as bridge therapy to transplant or even for supporting recovery of the heart. The INNOVATE trial will assess the system performance in both the short term, with a six-month endpoint, and in the long term over the course of the next 24 months.
Note: The BrioVAD System is an Investigational Device limited by Federal Law to use in the INNOVATE Trial.
About the INNOVATE Trial
The INNOVATE Trial is a prospective, non-blinded, randomized, controlled study that will enroll patients for both short-term and long-term Mechanical Circulatory Support indications.
About BrioHealth Solutions
BrioHealth Solutions is a medical device company headquartered in Burlington, Massachusetts. It develops, produces and commercializes devices to treat patients suffering from advanced and persistent heart failure.