Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has released new 30-day clinical results for its biomimetic DurAVR® transcatheter heart valve, reporting encouraging safety and performance outcomes in 100 severe aortic stenosis patients with small aortic annuli — a cohort where prosthesis-patient mismatch is more common.
The data, presented overnight at the PCR London Valves conference and published simultaneously in EuroIntervention, build on the company’s earlier findings from feasibility studies and the ongoing EMBARK program. The cohort represents around 20% of the planned DurAVR® enrolment for the all-comers randomised arm of PARADIGM, Anteris’ recently launched pivotal global trial.
Strong hemodynamic profile at 30 days
Across the 100-patient pooled dataset, DurAVR® delivered a mean effective orifice area (EOA) of 2.2 square centimetres and a single-digit mean pressure gradient of 8.2 millimetres of mercury (mmHg) — metrics that compare favourably with commercial balloon-expandable and self-expanding valves.
Key safety indicators were also positive, with no valve-related mortality and no moderate or severe paravalvular leak. Notably, prosthesis-patient mismatch (PPM) occurred in just 3% of patients, versus the 11–35% range reported for current transcatheter valves.
Anteris said the last 50 consecutive implants also achieved a 100% technical success rate.
Professor Ole De Backer, who presented the late-breaking data, said the results highlight a rare balance of device success, low pacemaker rates and strong haemodynamics in a group particularly vulnerable to PPM.
Anteris chief medical officer Dr Chris Meduri added: “Moderate to severe PPM is independently associated with reduced survival and increased risk of structural valve deterioration. Achieving 97% freedom from moderate or severe PPM is clinically relevant, particularly in small annuli patients where the risk of PPM is amplified.”
Supports momentum heading into PARADIGM trial
The results add further consistency to the clinical profile emerging around DurAVR®, complementing the one-year outcomes presented earlier this year.
Vice chairman and CEO Wayne Paterson said the growing dataset reinforces confidence as Anteris progresses the global PARADIGM randomised trial, which will compare DurAVR® against currently marketed transcatheter aortic valve replacement (TAVR) systems.
“When we look at the strength of the 30-day outcomes together with the 1-year results presented at TCT, we see a consistent clinical profile that serves as a potential proxy for the recently initiated PARADIGM Trial,” Paterson said.
PARADIGM (NCT07194265) will evaluate safety and effectiveness in a broad, all-comers population, advancing DurAVR® towards anticipated commercialisation.
DurAVR® is the first biomimetic, balloon-expandable valve designed to mimic natural aortic leaflet movement, using Anteris’ single-piece moulded ADAPT® anti-calcification tissue. The platform is intended to address long-standing durability and performance limitations in aortic stenosis treatment, particularly for younger and small-annulus patients.