Transdisciplinary coalition of industry, academia and clinical experts tackle heart failure in a world-first

MedTech & Diagnostics News: The Medical Research Future Fund (MRFF) has granted an impressive $50 million to a Monash-led program, marking the third-largest funding in the history of the scheme. The funding aims to propel the development and commercialisation of the world’s most advanced artificial heart, a technological marvel poised to significantly reduce heart failure-related deaths and contribute $1.8 billion to the nation.

The collaborative effort involves key players, including BiVACOR, an Australian-US medtech industry partner, and five prominent university partners: Monash University, University of Sydney, University of New South Wales, Griffith University, and University of Queensland. Additionally, three clinical partners – The Alfred, Baker Heart & Diabetes Institute, and St Vincent’s Health Australia – join forces, collectively forming the Total Artificial Heart.

BiVACOR’s founder and the visionary behind the Total Artificial Heart, Dr Daniel Timms, drew inspiration from his father’s struggle with heart failure. Dr Timms ingeniously applied water pump technology to devise a novel solution to artificial hearts.

Describing the innovation, project co-lead and Director of Cardiology at The Alfred, Professor David Kaye, emphasised “The Total Artificial Heart is intended to fully replace a natural heart, providing patients with a possible alternative to heart transplant.” He highlighted the limitations of current Ventricular Assist Devices, highlighting the Total Artificial Heart’s ability to adapt and respond to the body’s physical demands through novel engineering.

Mark Butler MP, Minister for Health and Aged Care, applauded the project’s implications that extend beyond health benefits. He stated “This is an incredible story of Australian ingenuity and sovereign manufacturing, with collaboration across universities, clinical hospitals, and industry to develop the world’s most advanced artificial heart.”

The Total Artificial Heart is one of three heart technologies being created under the Artificial Heart Frontiers Program, based at the Monash Alfred Baker Centre for Cardiovascular Research at The Alfred.

“Central to the program is the creation of a complete cardiac device ecosystem in Australia encompassing research, clinical trials, commercialisation, and the development of new manufacturing capabilities,” said project co-lead Associate Professor Shaun Gregory from Monash University’s Faculty of Engineering.

The United States Food and Drug Administration (FDA) has provided approval for the BiVACOR Total Artificial Heart to commence an investigational device exemption (IDE) for the first-in-human Early Feasibility Study (EFS). The study, that will extend to Australia in Q3 this year, will evaluate the safety and feasibility of the Total Artificial Heart as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure.

Heart failure affects over 23 million people globally, and the Total Artificial Heart offers a promising solution for the nearly 500,000 Australians living with the condition. Unlike its predecessors, the Total Artificial Heart employs state-of-the-art magnetic levitation technology, ensuring durability for over a decade, adaptability for both children and adults, and the promise of an active lifestyle for patients.

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