Aussie medtech moves to next stage of heart valve commercialisation strategy

Brisbane-based medtech company Anteris Technologies is positioning itself for the next stage of transcatheter aortic valve replacement (TAVR) therapy, as the field shifts toward longer-term outcomes and younger patient cohorts.

The company’s lead technology, the DurAVR transcatheter heart valve (THV), is being developed for patients with severe calcific aortic stenosis.

Designed as a biomimetic valve platform, DurAVR THV is described as a new class of device and is the world’s only balloon-expandable, single-piece transcatheter aortic valve engineered to replicate the performance of a native human aortic valve. This delivery system is intended to enable precise alignment with the heart’s native commissures, supporting accurate anatomical positioning.

Earlier this year, global medtech company Medtronic agreed to invest up to $90 million in Anteris Technologies, including a planned equity position of 16% to 19.99% in the company and its technology.

Against that backdrop, Anteris Technologies is now outlining an ambition to help define what it calls the next era of aortic stenosis care. As TAVR procedures extend into younger, lower-risk patients who may live for decades following intervention, evaluation metrics must evolve beyond procedural success alone. That includes assessing whether treatment restores healthier blood flow, reduces residual disease physiology, supports ventricular recovery, and improves long-term cardiac performance.

“TAVR changed cardiovascular medicine, but implantation is not the finish line,” said Wayne Paterson, Vice Chair and CEO of Anteris Technologies. “If TAVR is going to be used in patients who live longer, the standard must move from ‘was the implant successful?’ to ‘achieved disease modification or making it worse?’”

Industry-standard TAVR devices can leave patients in a mild disease state rather than fully restoring normal haemodynamics. This limitation becomes more pronounced as indications expand to younger, more active patients who require durable restoration of cardiac function rather than a purely procedural solution. Key considerations increasingly include durability, structural integrity, blood-flow optimisation, ventricular recovery and the feasibility of future interventions.

Anteris Technologies says its biomimetic valve design is intended to address these gaps by restoring more physiological blood flow patterns, and it is seeking to raise the bar for how clinical success is defined in the field.

“When you are treating an 85-year-old patient who may not live long enough to experience valve failure, it is easier to talk about the procedure as the victory,” Paterson said. “But when the patient is 60 or 65, that logic collapses. Now the valve has to perform for the life the patient still has ahead.”

The medtech is expanding its PARADIGM trial which is comparing the DurAVR system against commercially available TAVR devices.

“Medtech spent 20 years optimising the path to the valve,” Paterson stated. “Now, our approach is working to restore patients’ health and quality of life, with measurable restoration of the heart.”

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