The Texas Heart Institute (THI), BiVACOR®, Baylor St. Luke’s Medical Center, and Baylor College of Medicine announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) on July 9, 2024. This procedure is part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS). The BiVACOR TAH is a titanium-constructed biventricular rotary blood pump with a single moving part that utilizes a magnetically levitated rotor to pump blood, replacing both ventricles of a failing heart.
The study aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular heart failure or univentricular heart failure where left ventricular assist device support is not recommended. Following this initial implantation at Baylor St. Luke’s Medical Center by surgeons from Baylor College of Medicine, four additional patients are set to be enrolled in the study.
Dr. Alexis Shafii, surgical director of heart transplantation at Baylor St. Luke’s Medical Center and associate professor of surgery at Baylor College of Medicine, commented on the procedure: “As for the implantation in the human, it went as expected with no complications. Clinically, the device performed very well.” He added that having such an advanced device offers significant potential in cardiac care.
Dr. Joseph Rogers, President and CEO of The Texas Heart Institute and National Principal Investigator on the research, expressed enthusiasm about this milestone: “The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant.”
Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR stated: “I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute.”
Heart failure affects approximately 26 million people worldwide including 6.2 million adults in the U.S., with increasing prevalence rates. While fewer than 6,000 heart transplantations occur globally each year due to limited availability, mechanical circulatory support (MCS) could benefit up to 100,000 patients immediately according to estimates by U.S. National Institutes of Health.
Dr. Todd Rosengart from Baylor College of Medicine emphasized collaboration: “Today’s announcement represents a decade of diligence and perseverance... It reflects tremendous collaboration between Baylor College of Medicine, Texas Heart Institute, Baylor St. Luke’s Medical Center and BiVACOR.”
