Texas Heart Institute (THI) Vivacol®Baylor St. Luke's Medical Center and Baylor College of Medicine, a clinical-stage medical device company, today announced that the BiVACOR total artificial heart (TAH) has been successfully implanted in humans. The U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS) will be conducted on July 9, 2024.BiVACOR's TAH is a titanium biventricular rotary blood pump with a single moving part that uses a magnetically levitated rotor to pump blood and replace both of the failing ventricles.
This first-in-human clinical trial is designed to evaluate the safety and performance of the BiVACOR TAH as a pre-transplant solution for patients with severe biventricular or univentricular heart failure for whom left ventricular assist device support is not recommended. Following this initial implantation, completed at Baylor St. Luke's Medical Center by surgeons from Baylor College of Medicine, four additional patients are expected to be enrolled in the study.
“In terms of human implantation, it proceeded as expected without any complications, and clinically, the device performed very well,” said Dr. Alexis Shafi, chief of cardiac transplant surgery at Baylor St. Luke's Medical Center and associate professor of cardiothoracic transplant and circulatory support surgery at Baylor College of Medicine. “This technologically advanced device offers something special to the field.”
“The Texas Heart Institute is excited about the first implantation of the groundbreaking BiVACOR TAH. Heart failure remains a leading cause of death globally, and the BiVACOR TAH offers a ray of hope for countless patients awaiting a heart transplant,” said Dr. Joseph Rogers, president and CEO of the Texas Heart Institute and the study's national principal investigator. “We are at the forefront of this medical breakthrough and are proud to work with the dedicated teams at BiVACOR, Baylor College of Medicine and Baylor St. Luke's Medical Center to transform the future of heart failure treatment for this vulnerable population.”
“We are incredibly proud to witness our TAH being implanted in a human body for the first time,” said Dr. Daniel Timms, BiVACOR's founder and chief technology officer. “This achievement would not have been possible without the courage of our first patient and his family, the dedication of our team, and the collaboration of the experts at the Texas Heart Institute. Our TAH, utilizing advanced MAGLEV technology, has brought us one step closer to providing a much-needed option for people with end-stage heart failure who need support while they wait for a heart transplant. We look forward to moving forward to the next phase of clinical trials.”
Heart failure is a global epidemic affecting at least 26 million adults worldwide and 6.2 million in the United States, with incidence rates rising. Heart transplants are reserved for patients with severe heart failure, limiting numbers to fewer than 6,000 per year worldwide. As a result, the US National Institutes of Health estimates that up to 100,000 patients could immediately benefit from mechanical circulatory support (MCS), with a similarly sized market in Europe.
BiVACOR's successful TAH implantation highlights the potential of this innovative technology to address significant challenges in cardiac care, including long transplant waiting lists.
“Today's announcement is the culmination of a decade of hard work and perseverance. This never would have happened without the incredible collaboration in the ecosystem we enjoy at the Texas Medical Center. Not only does it enable powerful discoveries and inventions, it reflects the incredible collaboration between Baylor College of Medicine, Texas Heart Institute, Baylor St. Luke's Medical Center, and BiVACOR,” said Dr. Todd Rosengart, Michael E. DeBakey Professor and Chair of Surgery at Baylor College of Medicine and cardiac surgeon at Baylor St. Luke's Medical Center.
