Structural heart company Anteris Technologies Global Corp has fielded positive one-year results for patients treated with its proprietary DurAVR® Transcatheter Heart Valve (THV) System.
The latest data demonstrates the valve’s durability, hemodynamic performance and safety and bolsters the company’s mission – to develop innovative solutions for patients with structural heart disease.
The findings will be presented at the Sydney Valves conference on 21 March 2025.
Groundbreaking haemodynamic performance
“The one-year data for DurAVR® THV continues to validate its groundbreaking haemodynamic performance, demonstrating sustained excellent effective orifice area (EOA) and low mean gradients,” Anteris CMO Chris Meduri MD said.
“Most notably, this is the only transcatheter valve to show zero prosthesis-patient mismatch (PPM) in small annuli patients – an achievement that sets a new standard in TAVR.
“PPM is a well-established predictor of valve failure and disease progression, and eliminating it has profound implications for long-term patient outcomes.
“These results reinforce the transformative potential of DurAVR® as we move toward pivotal trials.”
Highlights
DurAVR® THV demonstrated a sustained hemodynamic profile with an Effective Orifice Area (EOA) of 2.1 cm², a Mean Pressure Gradient (MPG) of 8.6 mmHg and a Doppler Velocity Index (DVI) of 0.58.
Clinical safety outcomes remained positive, with no reported valve or cardiovascular-related mortality.
There were no instances of prosthesis-patient mismatch (PPM) were observed in patients with small annuli (aortic annulus area 395.80 mm²).
Comparatively, existing commercial devices report PPM rates between 11.2% and 35.3%, a known predictor of valve failure and disease progression.
The data further supports the safety and efficacy of the DurAVR® THV System, which has demonstrated high implant success rates throughout the clinical program.
A total of 65 patients have now completed the primary endpoint measure at 30 days, with results previously presented at multiple medical conferences throughout 2023 and 2024.
Regulatory approval movement
The one-year findings reinforce the potential of DurAVR® as a next-generation transcatheter valve technology.
The results will be included in Anteris Technologies' planned Investigational Device Exemption (IDE) submission to the US Food and Drug Administration (FDA).
The submission is aimed at securing approval for a randomised, global pivotal trial to further evaluate DurAVR® THV.