First-in-human implantation of BiVACOR's total artificial heart

The Texas Heart Institute and BiVACOR, a pioneering medical device company originally from Australia, have successfully achieved the first-in-human implantation of the latter’s total artificial heart (TAH). The groundbreaking procedure was completed as part of BiVACOR’s US FDA Early Feasibility Study, the purpose of which is to evaluate the safety and performance of the TAH 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.

Heart failure remains a leading cause of mortality globally, affecting at least 26 million people worldwide — but heart transplantations are reserved for those with severe heart failure and are currently limited to fewer than 6000 procedures per year. Mechanical circulatory support (MCS) could thus provide an immediate benefit to thousands, if not millions, of patients.

BiVACOR’s TAH is a titanium-constructed biventricular rotary blood pump designed to replace both ventricles of a failing heart. It uses magnetic levitation (MAGLEV) technology, the same principle used in high-speed trains, and therefore has no valves or flexing ventricle chambers. Instead, the pulsatile outflow is driven by a rapidly rotating impeller. The non-contact suspension provides large blood gaps minimising blood trauma and eliminating mechanical wear to offer a durable and biocompatible heart replacement.

The first-in-human implantation was performed at Baylor St. Luke’s Medical Center within the Texas Medical Center, in a critically ill 57-year-old man who was in cardiogenic shock and awaiting a heart transplant. Following the six-hour operation on 9 July 2024, the TAH was found to function as predicted based on BiVACOR’s preclinical studies.

“We were able to demonstrate that the device provided blood flow sufficient to maintain normal vital signs and normal organ function,” said Joe Rogers, President and CEO of The Texas Heart Institute. “It allowed the patient to be liberated from the ventilator on postoperative day 3 and sit up in a chair on that same day.

“He was able to ambulate 150 metres, which is equivalent to a 10th of a mile, on postoperative day 7.

“With activity the device auto-regulated to provide up to 12 litres of blood flow per minute, which is an amount similar to that pumped by a healthy human heart.

“I’m also pleased to report that after eight days of support on the BiVACOR device, a suitable donor heart was identified for the patient and he’s undergone successful transplantation.”

BiVACOR has been backed by Australian venture capital firm OneVentures, which also receives investment from the Australian Government’s Biomedical Translation Fund. More recently, Monash University’s Artificial Heart Frontiers Program, funded by the government’s Medical Research Future Fund, will support ongoing research for the next five years. Meanwhile, four additional patients are set to be enrolled in the clinical study.

“I’m incredibly proud to witness the successful first-in-human implant of our TAH,” said Dr Daniel Timms, founder and Chief Technology Officer of BiVACOR.

“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.”