Successful first-in-human implantation of valveless total artificial heart by Baylor College of Medicine and Texas Heart Institute announced
The Texas Heart Institute, BiVACOR®, a clinical-stage medical device company, Baylor St. Luke’s Medical Center and Baylor College of Medicine recently announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart as part of the U.S. Food and Drug Administration Early Feasibility Study. The titanium-constructed, novel device pumps the blood and replaces both ventricles of a failing heart.
Heart failure is a global epidemic affecting at least 26 million people worldwide, 6.2 million adults in the U.S., and is increasing in prevalence. Heart transplantations are reserved for those with severe heart failure and are limited to fewer than 6,000 procedures per year globally. Consequently, the U.S. National Institutes of Health estimated that up to 100,000 patients could immediately benefit from mechanical circulatory support, and the European need is similarly sized.
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 successful implantation of BiVACOR’s TAH highlights the potential of innovative technologies to address critical challenges in cardiac care, such as long transplantation waitlists.
Read the full Baylor news story here.
