Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has reported encouraging one-year clinical outcomes from its DurAVR® Transcatheter Heart Valve (THV) in patients with small aortic annuli, demonstrating durable hemodynamic performance and excellent safety results.
The data, drawn from 65 patients treated under the ongoing EMBARK and US Early Feasibility studies, showed sustained single-digit mean pressure gradients and large effective orifice areas (EOAs) after one year. Notably, no valve-related mortality or moderate/severe paravalvular leaks were observed.
Positive outcomes in challenging patient group
For patients with small aortic annuli — a group that often experiences less favourable results with conventional transcatheter aortic valve replacements (TAVR) — DurAVR® delivered strong and consistent performance.
At one year, the mean pressure gradient averaged 8.6 ± 2.6 millimetres of mercury (mmHg), while the mean EOA was 2.1 ± 0.2 square centimetres, indicating a favourable hemodynamic profile sustained over time.
At 30 days, the incidence of prosthesis–patient mismatch was just 1.5%, a significant improvement over the 11–35% typically seen in current commercial valves — a key indicator of reduced strain on the heart and lower long-term failure risk.
“The latest results we are seeing with the balloon-expandable DurAVR® valve are impressive, showing restoration of laminar flow, favourable hemodynamics sustained to one year, predictable deployment and a high level of procedural success across a variety of anatomies, which is exactly what we need for this patient population,” said Dr Rishi Puri, coronary and structural interventional cardiologist at the Cleveland Clinic.
“With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiologic flow is so critical,” he said.
Backed by global clinical validation
The results build on earlier findings from more than 100 patients treated with DurAVR® to date.
Anteris said the data reinforce the potential of its biomimetic valve design, which mimics the shape and motion of a healthy human aortic valve to replicate natural blood flow and minimise turbulence.
The company is now advancing its global PARADIGM Pivotal Trial (ClinicalTrials.gov ID NCT07194265) — a prospective, randomised controlled study that will compare DurAVR® against commercially available TAVR systems in the treatment of severe aortic stenosis.
Next steps for Anteris
The new data come at a busy moment for Anteris, which on Tuesday announced a A$38.5 million private placement to fund the PARADIGM trial and scale up manufacturing capacity. It also revealed the successful treatment of first patients in the trial, in Denmark.
DurAVR® is built using Anteris’ patented ADAPT® tissue technology, an FDA-cleared anti-calcification platform used in more than 55,000 patients worldwide.
The system comprises the DurAVR® valve, ADAPT® tissue, and the balloon-expandable ComASUR® delivery system.
Anteris said the sustained one-year data reinforce DurAVR®’s potential to redefine treatment outcomes for patients with small annuli — a traditionally underserved population in structural heart care.