A team at the Houston-based Texas Heart Institute has performed a successful first-in-human implantation of the BiVACOR Total Artificial Heart.
The implantation took place July 9 as part of the device's FDA early feasibility study, according to a July 25 new release from the institute.
BiVACOR is a clinical-stage medical device company. The TAH device is made of titanium and uses a magnetically levitated rotor to pump blood, replacing both heart ventricles, the release said.
"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," Joseph Rogers, MD, president and CEO of the Texas Heart Institute, said in the release.
Heart transplants are typically reserved for patients suffering from severe heart failure, leaving many cardiac patients left to wait on long transplant lists. Researchers believe the successful TAH implantation procedure "highlights the potential of innovative technologies to address critical challenges in cardiac care," the release said.
Under the FDA-approved study design, four additional patients will be enrolled as the clinical trial continues.
Baylor St. Luke's Medical Center is located in the Texas Medical Center and is home to the Texas Heart Institute.