What is the DurAVR® THV?

A next-generation biomimetic transcatheter heart valve designed to closely replicate the performance of a natural human valve.

What is unique about the recent dual valve procedure?

It marked the first known case of DurAVR® being successfully implanted in both the mitral and aortic valve positions during the same intervention.

What is the PARADIGM Trial?

A pivotal global clinical study designed to further validate the safety and performance of DurAVR® in treating aortic stenosis.

Anteris Technologies Advances Global Clinical Program for DurAVR® THV

3 min read | August 12, 2025 11:24 AM AEST | By Team Kalkine Media

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Anteris Technologies Advances Global Clinical Program for DurAVR® THV — Image source: Shutterstock

Progress Towards the PARADIGM Trial

In preparation for its pivotal global PARADIGM Trial, Anteris completed the qualification of multiple clinical sites across the United States, Europe, and Canada. These centres were assessed for their readiness to enrol suitable aortic stenosis patients and maintain adherence to trial protocols.

The company hosted international investigator meetings, bringing together leading cardiology specialists from across Europe and North America. This collaborative effort aims to accelerate patient recruitment and ensure robust trial outcomes. Alongside clinical expansion, Anteris engaged with the US Food and Drug Administration (FDA) to progress its Investigational Device Exemption (IDE) application and scaled manufacturing capabilities to meet anticipated study demand.

For readers tracking developments in the broader market, innovations like DurAVR® often gain interest within indexes such as the ASX 200, given their potential to influence the medtech sector’s performance.

Leadership Strengthened for the Next Phase

Anteris has also enhanced its governance structure by appointing two new non-executive directors. Their combined expertise in operational leadership, legal strategy, and corporate governance is expected to support the company’s transition into a pivotal stage of clinical validation and market readiness.

While financial results for the period reflected increased investment in regulatory, clinical, and manufacturing activities, these expenditures align with the company’s strategic objective of delivering long-term value through groundbreaking cardiovascular solutions.

Frequently Asked Questions

What is the DurAVR® THV?
A next-generation biomimetic transcatheter heart valve designed to closely replicate the performance of a natural human valve.
What is unique about the recent dual valve procedure?
It marked the first known case of DurAVR® being successfully implanted in both the mitral and aortic valve positions during the same intervention.
What is the PARADIGM Trial?
A pivotal global clinical study designed to further validate the safety and performance of DurAVR® in treating aortic stenosis.

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