- The disease
- Aortic stenosis is a narrowing of the aortic valve opening in the heart, reducing blood flow from the heart to the rest of the body. In severe cases, the valve leaflets become heavily calcified and stiff, impairing cardiac function. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure in which a replacement valve is delivered via catheter, avoiding open-heart surgery. Valve-in-valve procedures use the same technique to replace a previously implanted surgical or transcatheter valve that has failed.
- What the asset is trying to do
- DurAVR THV is a transcatheter heart valve (THV) made from a single piece of bovine (cow) pericardium tissue processed using the company's ADAPT anti-calcification technology. The single-piece construction is designed to mimic the shape of the native aortic valve, in contrast to the conventional three-piece leaflet design used in most commercially available TAVR valves. The valve uses a balloon-expandable delivery system. The ADAPT tissue processing technology has received FDA clearance and has been used in more than 55,000 patients with a reported calcium-free record of over 10 years (per Anteris Technologies company disclosures).
- What the trial is measuring, and why it matters
- The pivotal PARADIGM trial is a randomised study comparing DurAVR THV directly against two commercially approved TAVR systems, the SAPIEN THV series and the Evolut THV series (per ClinicalTrials.gov NCT07194265). The trial is designed to assess safety and effectiveness in patients with severe aortic stenosis, including valve-in-valve candidates. Head-to-head randomised trials against approved devices are the standard method regulators use to evaluate whether a new TAVR system offers an acceptable safety and effectiveness profile relative to established alternatives.
- Efficacy benchmarks in this setting
- Approved TAVR devices in the severe aortic stenosis setting have established clinical benchmarks across multiple large trials. For example, the PARTNER 3 trial reported all-cause mortality, stroke, or rehospitalisation rates at one year for the SAPIEN 3 valve versus surgery (Leon et al, New England Journal of Medicine 2019). The Evolut Low Risk trial similarly reported outcomes for the Evolut valve versus surgery (Popma et al, New England Journal of Medicine 2019). Hemodynamic performance metrics such as effective orifice area and mean aortic gradient are also established comparators in this field. Any early-stage or feasibility figures reported for DurAVR THV to date are from small, non-randomised studies and are not statistically comparable to the controlled pivotal trial data generated for approved devices.
- Commercial context
- Multiple TAVR devices are already approved in the severe aortic stenosis setting, including the Edwards Lifesciences SAPIEN series and the Medtronic Evolut series, which serve as the active comparators in the PARADIGM trial (per ClinicalTrials.gov NCT07194265). The PARADIGM trial has received FDA Investigational Device Exemption (IDE) approval (November 2025) and Danish Medicines Agency approval (October 2025), and French regulatory clearance was announced in June 2026 (per Anteris Technologies ASX announcements). The first US patients were treated in the PARADIGM trial in May 2026 (per Anteris Technologies ASX announcement, 5 May 2026). DurAVR THV is described as Anteris Technologies' lead pipeline asset. A material definitive agreement was entered into on 23 April 2026 and a separate agreement was terminated on 29 April 2026 (per Anteris Technologies ASX announcements); further details of those agreements are .