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 US Food and Drug Administration ( FDA ) Early Feasibility Study ( EFS ). 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-totransplant 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 .

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