Surgeons at Baylor St. Luke’s Medical Center in the Texas Medical Center completed the procedure on July 9. The first-in-human clinical study utilizing the TAH aims to evaluate the safety and performance of the system 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 the first implant, BiVacor plans to enroll four additional patients in the study.

Houston-based BiVacor designed the TAH to replace the function of the native heart completely. Sized similarly to an adult fist, it uses magnetic levitation technology. Left and right vanes positioned on a common rotor form the only moving part, a magnetically suspended double-sided centrifugal impeller. BiVacor designed it to create pulsatile outflow by rapidly cycling the rotational speed of the impeller. The non-contact suspension provides large blood gaps to minimize blood trauma and eliminate mechanical wear.