The Texas Heart Institute (THI), BiVACOR, a clinical-stage medical device company, Baylor St. Luke’s Medical Center and Baylor College of Medicine have announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) as part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS) on July 9, 2024. BiVACOR’s TAH is a titanium-constructed biventricular rotary blood pump with a single moving part that utilises a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart.
The first-in-human clinical 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 in which left ventricular assist device support is not recommended. Following this first implantation completed at Baylor St. Luke’s Medical Center by Baylor College of Medicine surgeons, four additional patients are to be enrolled in the study.
“As for the implantation in the human, it went as expected with no complications. Clinically, the device performed very well,” said Dr Alexis Shafii, Surgical Director of Heart Transplantation at Baylor St. Luke’s Medical Center and Associate Professor of Surgery – cardiothoracic transplant & circulatory support at Baylor College of Medicine. “Having this technologically advanced device is offering something special in the field.”
“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,” added Dr Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research.