First Patient Implanted with BiVACOR Artificial Heart

Image credit: Gerd Altmann via Pixabay

Pioneering Australian medtech, BiVACOR has announced the successful first-in-human implant – and removal – of its Total Artificial Heart (TAH), as part of the US Food and Drug Administration (FDA) Early Feasibility Study into the device.

The study investigates the safety and performance of the titanium-constructed BiVACOR TAH as a bridge-to-transplant solution for people with severe biventricular or univentricular heart failure, where left ventricular assist device support is not clinically indicated.

BiVACOR Founder and Chief Technology Officer, Dr Daniel Timms said he was “incredibly proud” to witness the successful implant and continue the next phase of its clinical trial.

“Utilizing advanced MAGLEV [magnetic levitation] 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,” said Dr Timms (pictured above) in a statement.

Four additional patients are now to be enrolled in the study.

In a further update late last month, BiVACOR announced the patient implanted with the TAH device had gone onto receive a donor heart transplant eight days later, allowing for the removal of the TAH and demonstrating its viability as a bridge-to-heart-transplant solution.

Check out the press releases from BiVACOR for more information.