Queensland MedTech engineer “goes global” with new-generation artificial heart

News - 22 Jul 2022

Queensland biomedical engineer Dr. Daniel Timms and his dedicated team at BiVACOR embarked on an around-the-world journey spanning two decades; researching, developing, and testing a new generation artificial heart – an innovation that could save thousands of lives worldwide.

Dr Daniel Timms is the Founder and Chief Technical Officer (CTO) of MedTech company BiVACOR, headquartered in Texas in the United States, with an Australian head office at Cohort in the Gold Coast Health and Knowledge Precinct. He and his team have spent years developing the world’s first rotary total artificial heart (TAH), a potential gamechanger for thousands of heart disease sufferers worldwide who are waiting for a donor heart transplant.

The BiVACOR team has worked across multiple continents to develop the novel technology, including important years of research and development within labs at Lumina, in the Gold Coast Health and Knowledge Precinct. Most recently, working between Queensland, Texas, and California, BiVACOR is approaching the exciting stage of clinical trials, which will test their life-saving technology in real patient studies and see their vision of replacing hearts and restoring lives come to fruition.

BiVACOR is a ‘total artificial heart’ designed to take over the complete function of a patient’s failing heart

The implantation of a ‘total artificial heart’ (TAH) is primarily a treatment option for heart failure patients who need support while on a heart transplant waiting list, securing precious time until a donor’s heart is available, or as an option for those that do not qualify for a transplant. According to the US National Institute of Health (NIH), 100 000 patients in the United States are awaiting a heart transplant. However, globally, around only 4,000 donor hearts become available each year. It is an enormous gap where the BiVACOR TAH can play a life-saving role.

Innovation in magnetic engineering solved historical issues around artificial heart durability and capability

The first successful TAH implantation was performed in the 1980s in the United States, with the patient’s life extended by just over 100 days. Since then, the technology has advanced to further extend the life expectancy of patients and enhance their quality of life. However, despite technological advancements, the biggest issue with previous variations of artificial hearts, even today, is their durability – how to stop them from breaking. A secondary issue is compatibility – how to pump blood effectively and not damage the blood cells.

Dr. Timms explained that the BiVACOR TAH has addressed both historical challenges, using advancements in magnetic levitation technology using a rotary blood pump. Because the rotary blood pump is levitated using magnetic force (it is suspended in the blood), there is no mechanical wear on the device. Ultimately, this means that the TAH can last for ten years or more and not wear out and break, which has traditionally hampered the use of artificial hearts in the past.

“Because of the durability issues of past devices, they were only used to temporarily help patients until they could find a transplant. It was about three months or, maximum, a year before they would break down and damage the blood cells that were being pumped through the artificial heart device,” Dr. Timms explained.

“This is another advantage of magnetic levitation; we can create relatively large blood flow gaps in the pump that are very ‘blood friendly’ so the blood cells that are passing through the BiVACOR are not damaged as much as they are in previous generations of TAHs.”

The rotary pump design itself is also a gamechanger, with its dual left and right-side pumping ability, which addresses limitations on previous devices that were pumping on the left side of the heart only. While single chamber pumps did help extend life expectancy, they did not improve a patient’s quality of life, supporting only limited physical activity and cardiac output. The BiVACOR dual-chamber technology, however, can both extend and enhance the life of patients.

Global partners and a dedicated international core team were essential to progress BiVACOR innovation

The multi-disciplined BiVACOR team is a strong collaborative network that extends nationally and internationally, with experts from Australia, Japan, Germany, and North America, many of whom have been together since the beginning.

“Once we realised the solution had to involve magnetic levitation, which we initially developed in Queensland, we knew we needed to go to Japan, where there is vast experience with this technology. Our first step was to work in a lab in Japan and learn about magnetic rotation technology and how to apply that to the design we wanted to create.”

“After we got the levitation and the pumping technology right, we needed to figure out how to produce it. The best people to partner with were in Germany, so we worked with German scientific engineers from the RWTH Aachen University and the Helmholtz Institute,” Dr. Timms said.

From then, the team took a prototype to the Texas Heart Institute in Houston to share with leading cardiac surgeons and test the implementation and functionality of the rotary pump, including speed and how to power the device. The Queensland State Government provided the funding that supported that initial United States visit ten years ago as part of the Advance Queensland initiative.

“We worked with domain experts in their different disciplines, and many of them are still on this journey with us today, dedicated to their mission. One of our team members from Japan joined us 20 years ago, and one of our German engineers has been with us for ten years. Some of the surgeons I first met ten years ago in Houston I saw again just this month.”

Griffith University and the surrounding Lumina ecosystem supported an important part of the BiVACOR journey

Collaborations and world-class facilities closer to home in the Gold Coast Health and Knowledge Precinct were also vital components to BiVACOR’s success. Dr Timms recently spent nearly two years working with his PhD mentor Professor Tansley and other collaborators in the Mechanobiology Research Laboratory at Griffith University to perform final research and analysis on blood compatibility.

“When I was back in Queensland, I knew we had to do the testing in Professor Tansley’s world-leading lab at Griffith University. We then set up an office nearby at Cohort Innovation Space, so we could take full advantage of its facilities and proximity to the testing lab,” Dr Timms said.

“The Lumina ecosystem is valuable – putting a facility like Cohort close by to the hospital and the university just facilitates collaboration. My time there really encouraged me to see that, and how different disciplines, like engineering, medicine and business can work together. I don’t think there is anywhere else in Australia that is so well situated within an innovation space.”

The future of BiVACOR includes a global impact and a dedicated Queensland presence

Once the lengthy US Food and Drug Administration (FDA) verification process is complete, the next few years for BiVACOR will see the technology move out of the lab and be tested in real patients for the first time across the United States and Australia. At the time of writing, this verification process is underway.

After clinical trials are successful, the team will continue to progress the technology. For example, they will look to miniaturise the TAH external battery pack, until a time when it can be implanted into the patient and charged by transferring the energy across the patient’s skin. There is also a potential opportunity to work with paediatric specialists in the United States to customise the technology specifically to support children requiring heart transplants.

While much of this work will be done with hospitals and institutes based overseas, Dr Timms is adamant that BiVACOR’s future includes a more permanent return to an innovation ecosystem such as Lumina.

“The talent in Australia is untapped; I will definitely be back in South East Queensland. Bringing that link back to the States enables a pathway for ideas to mix and provides an opportunity to get an important global visualisation of the ideas. Having more bridges between countries like the US and Australia is vital for any big MedTech ideas to get off the ground.”

“It’s really top of my mind to come back to the Precinct one day, after we progress through patient trials, and facilitate additional research applications and advancements to our core technology. It is a great place to research, and I’d love to be around this area again in the future.”

 

BiVACOR