HQ Team
March 15, 2025: An Australian man in his forties has become the first person in the world to be discharged from a hospital with a fully artificial heart made of titanium. The device, known as BiVACOR, is designed as a temporary solution for patients with severe heart failure who are awaiting a donor heart.
The man, whose identity has not been disclosed, lived with the BiVACOR device for over three months before successfully receiving a human heart transplant. According to a statement from St Vincent’s Hospital Sydney, where the surgeries were performed, the patient is recovering well. This achievement makes him the sixth person globally to receive the BiVACOR device but the first to live with it outside a hospital setting for an extended period.
Lead surgeon, Paul Jansz, told press in Australia the invention is a “complete game-changer“, and the event gave him “goosebumps”.
Revolutionary device for heart failure patients
BiVACOR, invented by biomedical engineer Daniel Timms, is a total heart replacement that functions as a continuous pump. Unlike traditional mechanical heart devices that primarily support the left side of the heart, BiVACOR replaces the entire heart. Its key innovation lies in its magnetically suspended rotor, which propels blood in regular pulses throughout the body. The device is connected via a cord tunnelled under the skin to an external, portable controller powered by batteries during the day and plugged into mains at night.
Dr. Joseph Rogers, a heart-failure cardiologist and president of the Texas Heart Institute in Houston, who led the first U.S. trial of the device, emphasized the significance of this achievement. “This is the first time a patient has been able to live outside the hospital with this device, which provides valuable insights into how people cope with it in real-world settings,” he said.
Global organ shortage
Heart failure is a growing global health crisis, with nearly 7 million adults in the U.S. alone living with the condition. However, only about 4,500 heart transplants were performed in 2023, largely due to a shortage of donor organs. BiVACOR offers a potential lifeline for patients who may not be eligible for transplants due to age or other health conditions. While it is currently used as a temporary measure, some cardiologists believe it could eventually become a permanent solution for certain patients.
Dr. Julian Smith, a cardiac surgeon at Monash University’s Victorian Heart Institute in Melbourne, described the development as “an important step forward.” However, experts like Dr. Sarah Aitken, a vascular surgeon at the University of Sydney, caution that many questions remain unanswered. “We still need to understand the level of function patients can achieve with this device and its long-term cost implications,” she said. “This kind of research is incredibly challenging due to the high costs and risks involved.”
Future Prospects
In the US, five men aged between their mid-forties and mid-sixties received an earlier version of the BiVACOR device last year as part of a trial led by Dr. Rogers. While the device sustained these patients for up to a month in the hospital, it was not designed for home use. All five individuals later received donor hearts and were discharged. Rogers plans to present the trial results at a scientific meeting in April.
Since then, the BiVACOR team has made improvements to reduce the risk of device failure, according to Dr. William Cohn, a heart surgeon at the Texas Heart Institute and chief medical officer at BiVACOR. The U.S. Food and Drug Administration (FDA) has approved expanding the trial to include an additional 15 patients.
Challenges and next steps
Despite the promising results, experts emphasize that widespread accessibility to this technology is still years away. “There are many steps before this becomes a treatment the general public can access,” Dr. Aitken noted. The high cost of the device and the complexity of the surgery remain significant barriers.
In a related development, the FDA recently approved the first trial for pig-organ transplants, another innovative approach to addressing the global organ shortage. These advancements highlight the urgent need for alternative solutions in organ transplantation and cardiac care.
