HOUSTON – The Texas Heart Institute announced a major milestone Thursday afternoon in the cardiovascular health space, regarding the implantation of a revolutionary total artificial heart
Officials from the Texas Heart Institute (THI) were joined by other health officials from BiVACOR, Baylor St. Luke’s Medical Center, Baylor College of Medicine, and the Texas Medical Center.
THI and BiVACOR 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.
“This is a big day for all of us and one that was... probably 22 years in the making,” said Dr. William “Billy” Cohn from the Texas Heart Institute and Chief Medical Officer of BiVACOR.
According to a release, BiVACOR’s TAH is a titanium-constructed biventricular rotary blood pump with a single moving part that utilizes a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart.
“The heart of the heart is this spinning disk,” said Daniel Timms, founder and chief technology officer of BiVACOR. “When it’s levitated like that, there’s no mechanical wear. So, that means the device should really never really wear out, so long as it’s getting power.”
This is an improvement to previous artificial hearts which could break in as little as 90 days, Cohn said.
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 in which left ventricular assist device support is not recommended. Following this first implantation completed at Baylor St. Luke’s Medical Center in the Texas Medical Center, four additional patients are to be enrolled in the study.
“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,” said Dr. Joseph Rogers, president and chief executive officer of The Texas Heart Institute and National Principal Investigator on the research. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”
This is not the first time the Texas Heart Institute has been as the forefront of heart technology. In 1969, Dr. Denton Cooley made history by implanting the first artificial heart.
Timms said, “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. Utilizing advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial.”