Monash—BiVACOR team to lead new frontier in artificial heart technology

Monash University and BiVACOR are leading a consortium of universities, hospitals and industry to develop and commercialise the world’s first durable total artificial heart.

With $1 million in federal government funding via the Medical Research Future Fund (MRFF), the Artificial Heart Frontiers Program will develop and commercialise new devices through the use of novel, innovative technology. The research team is aiming to take this new technology to market within the six-year duration of the MRFF Frontiers program, and hopes to save lives, create jobs and establish Australia as a worldwide leader in the medical device sector.

The BiVACOR Total Artificial Heart is an implantable total artificial heart based on rotary blood pump technology. Similar in size to an adult fist, it is small enough to be implanted in many women and some children, and is capable of providing enough cardiac output to an adult male undergoing exercise.

The heart’s design incorporates magnetic levitation (MAGLEV) technology — the same principle used in high-speed trains — and includes left and right vanes positioned on a common rotor to form the only moving part, a magnetically suspended double-sided centrifugal impeller.

BiVACOR TAH Product Clip from BiVACOR on Vimeo.

The team has already engaged partners across Australia, Asia Pacific, the USA and Europe; established regulatory approval pathways; and recently closed a $19 million Series B financing round to fund the company’s preclinical verification activities and the addition of key team members to support the first in-human studies.

“The Artificial Heart Frontiers Program will apply cutting-edge ideas and technology to develop and commercialise new-to-world applications to support all patients with heart failure,” said Professor David Kaye, Heart Failure Research Laboratory Lead at Monash University and Lead of the Artificial Heart Frontiers Program.

“This will be achieved initially with our Australian-born, innovative BiVACOR Total Artificial Heart, which is a complete replacement for a native heart.

“This platform technology will then be leveraged in the Artificial Heart Frontiers Program to develop the next-generation of devices to support more patients with heart failure. This will provide a suite of devices for heart support to the Australian and global population.”

More than 300,000 Australians are estimated to live with heart failure, with an additional 30,000 new cases diagnosed every year. Heart failure is a global pandemic affecting at least 26 million people worldwide and increasing in prevalence. It is the second leading cause of death in the US and Europe, and kills 118 Australians daily — one every 12 minutes — costing the Australian economy more than $5 billion each year.

The huge discrepancy between supply and demand for donor hearts necessitates the use of mechanical circulatory support devices that assist or take over the blood-pumping function of the native heart as either a permanent alternative to transplant or until a donor heart is received.

The majority of patients suffer left ventricular failure and receive support from left ventricular assist devices (LVADs). LVADs leave the heart in place and provide support to only the left ventricle. However, many patients also suffer from right ventricular heart failure, and the lack of durable total heart support devices means these patients receive suboptimal or no support, and unfortunately succumb to their condition.

The BiVACOR-created Total Artificial Heart includes an optimised hydraulic system to support both sides of the heart, powerful magnetic levitation and rotation systems that significantly enhances durability and biocompatibility, small device size to support more patients, and flow adaptation that responds to patient requirements without user input.

BiVACOR founder Dr Daniel Timms said, “No durable, permanent total artificial heart exists clinically for full heart support, thus presenting a clear gap in patient treatment that the research team was keen to fill.

“The smaller size and improved anatomical fitting of our devices will expand the population who are able to be treated by this form of therapy, including women and children. Most importantly, no immunosuppressive drugs are required.

“The quiet operation of our device, combined with the smaller, lighter and lower power consumption of the pump controller, will provide a less cumbersome experience to the patient. Furthermore, the adaptive nature of the blood flow output from our devices, with the maximum output enabling patients to exercise, will provide for a greatly improved quality of life,” Dr Timms added.

Senior Research Fellow in the Department of Mechanical and Aerospace Engineering at Monash University Dr Shaun Gregory said the project aims to significantly reduce the burden of heart failure in Australia, and globally, through groundbreaking multidisciplinary research that will lead to the development and commercialisation of cutting-edge devices that support or replace the heart.

“We hope that at the conclusion of the Artificial Heart Frontiers Program we can create a new medical technology enterprise within Australia through world-leading multidisciplinary research and development, building the capacity and capability for translational research of Australia’s health and medical research sector,” he said.

“We are the right team, with the right technology, at the right time, to lead a new frontier in artificial hearts.”

Image courtesy of BiVACOR