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.
The company received FDA investigational device exemption to conduct a first-in-human study for the system in November.
“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,” said Daniel Timms, founder and CTO of BiVacor said. “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.”
