A man in his 40s has made medical history by surviving 100 days with an artificial titanium heart while awaiting a donor transplant, marking the longest period anyone has lived with this innovative technology. The groundbreaking procedure was performed at St. Vincent's Hospital Sydney last November as part of ongoing clinical trials for the BiVACOR Total Artificial Heart (TAH).
The patient, who chose to remain anonymous, was discharged from the hospital in February, becoming the first person worldwide to leave a medical facility with the device. Earlier this month, he successfully received a donor heart transplant and is reportedly "recovering well," according to a joint statement from St. Vincent's Hospital, Monash University, and BiVACOR.
"The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart," said Daniel Timms, the Australian bioengineer who founded BiVACOR and invented the device following his father's death from heart disease. "Their bravery will pave the way for countless more patients to receive this lifesaving technology."
Revolutionary Technology
The BiVACOR TAH represents a significant advancement in artificial heart technology. Unlike previous mechanical hearts, it features a single moving part—a levitated rotor held in place by magnets. Constructed from titanium, the device contains no valves or mechanical bearings that might be susceptible to wear, potentially offering greater durability and reliability.
The artificial heart effectively replaces both ventricles of a failing heart, pumping blood to both the body and lungs. This comprehensive approach distinguishes it from ventricular assist devices that support only one side of the heart.
Professor Chris Hayward from the Victor Chang Cardiac Research Institute, who oversaw the Australian patient's recovery and helped prepare the device for clinical trials, described the BiVACOR heart as ushering in "a whole new ball game for heart transplants."
"Within the next decade we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available," Hayward predicted.
Clinical Trial Progress
The BiVACOR TAH has already shown promising results in the Food and Drug Administration's Early Feasibility Study in the United States. The first U.S. implantation occurred in July when a 58-year-old man with end-stage heart failure received the device during surgery at Texas Medical Center. It sustained him for eight days until a donor heart became available.
Four additional patients have since participated in the study, which examines the safety and performance of the device while patients await donor transplants. The trial is expected to expand to include 15 patients in total.
The Australian implant represents the first in a series planned by Monash University's Artificial Heart Frontiers Program, a 50 million Australian dollar ($31 million) initiative focused on developing and commercializing three devices to treat heart failure.
Addressing a Critical Need
Cardiovascular diseases remain the leading cause of death globally, claiming approximately 18 million lives annually according to the World Health Organization. In the United States alone, about 3,500 people received heart transplants in 2024, while approximately 4,400 joined the waiting list during the same period.
The significant gap between available donor hearts and patients in need underscores the potential impact of the BiVACOR TAH. If approved for general use, the device could provide a lifesaving alternative for thousands of patients with severe heart failure who might otherwise not survive the wait for a suitable donor.
Funding for Future Development
BiVACOR is currently raising $100 million to fund additional clinical trials that could eventually lead to widespread implementation of its artificial heart technology. The company envisions its device potentially being implanted in tens of thousands of patients suffering from severe heart failure.
The successful 100-day implantation in Australia represents a critical milestone in the development of artificial heart technology. While the device remains in the trial phase and has not yet received approval for general use, the recent success provides compelling evidence of its potential as both a bridge to transplantation and possibly a long-term solution for heart failure patients.
As clinical trials continue and refinements are made, the BiVACOR TAH could fundamentally transform the treatment landscape for end-stage heart failure, offering hope to patients worldwide who currently face limited options and uncertain futures.
