A human has successfully received a titanium heart.
The Texas Heart Institute (THI) and BiVACOR, a clinical-stage medical device company, announced Thursday (25 July) the first-in-human implantation of the BiVACOR Total Artificial Heart (TAH).
The titanium heart uses magnetic levitation – or maglev – technology with the same principle used in high-speed trains. It offers a so-called bridge-to-heart-transplant solution for patients living with severe conditions for when a donor heart becomes available.
On 9 July, the Texas Heart Institute implanted the TAH heart into a critically ill 57-year-old man who was in cardiogenic shock and awaiting a heart transplant. The procedure was carried out as part of a U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS).
The nearly six-hour operation allowed the patient to be liberated from the vent on post-operative day three, and sit in a chair that same day. On post-op day seven, he could ambulate 150 metres.
On 17 July, eight days after the implant, a donor heart became available.
A BiVACOR spokesperson said: “It was transplanted into the patient, removing the BiVACOR TAH and meeting the EFS’s goal of evaluating the safety and performance of the BiVACOR TAH as a bridge-to-heart-transplant solution for patients living with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended.”
The patient celebrated his 58th birthday on Tuesday and he is reported to be continuing to recover from the transplant in the hospital.
As the TAH is a titanium-constructed biventricular rotary blood pump that uses magnetic levitation – or maglev – technology, it means the product features a unique pump design with a single moving part.
The non-contact suspension of the rotor via maglev is designed to eliminate the potential for mechanical wear and provide large blood gaps that minimise blood trauma, offering a durable, reliable, and biocompatible heart replacement.
With activity, the device is auto-regulated to provide up to 12 litres of blood flow per minute, which is similar to that pumped by a healthy human heart.
Following this first implantation completed at Baylor St. Luke’s Medical Center in the Texas Medical Center, four additional patients are to be enrolled in the study.
“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,” said Dr. Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”
Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR said, “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. Utilising 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.”
