Anteris DurAVR THV Studied in Patients With Small Aortic Annuli

November 17, 2025—Anteris Technologies Global Corporation announced 30-day clinical outcomes in 100 severe aortic stenosis patients with small aortic annuli (SAA; aortic annulus area, 404 ± 37 mm²) treated with the company’s small-size DurAVR transcatheter heart valve (THV).

The company stated that the pooled analysis was derived from the ongoing EMBARK study and early feasibility studies (EFS) conducted in the United States and Europe.

According to the company, the DurAVR device demonstrated single-digit mean gradients, large effective orifice areas (EOA), no moderate or severe paravalvular leaks (PVLs), and no valve-related mortality, with 97% freedom from moderate or severe prosthesis-patient mismatch (PPM) in a cohort of small annuli patients similar to the findings in SMART—the postmarket trial that evaluated the Evolut self-expanding TAVR system (Medtronic) versus the Sapien balloon-expandable TAVR system (Edwards Lifesciences).

The late-breaking science was presented by Professor Ole De Backer, MD, at the PCR London Valves 2025 conference and simultaneously published online by Prof. De Backer et al in EuroIntervention.

As outlined in the company’s press release, highlights of the 30-day results for 100 DurAVR THV patients included the following:

• DurAVR THV delivered a favorable hemodynamic profile with a large EOA of 2.2 ± 0.3 cm² and a single digit mean pressure gradient (MPG) of 8.2 ± 3.1 mm Hg.
• At 30 days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe PVL.
• PPM was just 3.0% compared with 11.2% to 35.3% for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression.
• A 100% technical success rate (per Valve Academic Research Consortium’s VARC-3 definition) was achieved in the last 50 consecutive patient implants.

“The DurAVR THV demonstrated high rates of technical and device success with encouraging 30-day hemodynamic outcomes, including very low PPM in small annuli patients,” commented Prof. De Backer in the press release. “These results reflect a unique balance of balloon-expandable benefits characterized by high device success and low pacemaker rates, combined with a hemodynamic profile typically associated with self-expanding platforms.”