Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has delivered encouraging 12-month results from the DurAVR™ first-in-human (FIH) study, designed to evaluate the safety and efficacy of the DurAVR Transcatheter Heart Valve (THV) in patients with symptomatic severe aortic stenosis.
The study demonstrated a safety profile described as "outstanding" and has met all performance endpoints with remarkable hemodynamic function sustained for 12 months.
Further, all safety endpoints were also met with no mortality (all causes), no disabling stroke, no life-threatening bleeding and no myocardial infarction at 12 months.
The DurAVR™ THV is a new class of aortic valve replacement devices that utilise the patented ADAPT® anti-calcification process and innovative tissue-shaping technology in the world’s first single-piece transcatheter heart valve.
Looking ahead, these encouraging preliminary first-in-human study results will be further validated in an FDA-approved early feasibility study (EFS) in early 2023.
“Powerful real-world evidence”
Anteris’ CEO Wayne Paterson said: “This strong safety and hemodynamic data for DurAVR™ THV at 12 months reinforces the tireless work of the entire Anteris team, presenting powerful, real-world evidence of the benefit Anteris technology delivers to aortic stenosis patients.
“DurAVR™THV demonstrates its single piece of shaped tissue and novel design result in biomimetic behaviours that mirror the function of a healthy human aortic valve. Furthermore, we see the restoration of severely stenotic aortic valves back to pre-disease states with normal function.
“This firmly establishes DurAVR™ THV in an entirely new class of replacement heart valves. These results represent a major clinical milestone and value catalyst in our journey to bring DurAVR™ THV to patients worldwide that need a better valve.”
Unique biomimetic design
DurAVR™ THV’s unique, first-in-class biomimetic design replicates the normal blood flow of a healthy human aortic valve.
Anteris CMO Dr Chris Meduri said: “The DurAVR™ THV demonstrates how meaningful and differentiated innovation translates into real clinical benefits for patients suffering from aortic stenosis.
“The preservation of the impressive hemodynamics and safety out to 12 months in this first-in-human study is very encouraging. We are excited to expand this study to the United States in the near future with a recently FDA-approved early feasibility study (EFS).”
Study highlights
The first five patients implanted with DurAVR™ THV continue to show stable, improved valve function with excellent safety at 12-month follow-up demonstrated as follows:
- Increased average Effective Orifice Area (EOA) by 294% from baseline, as observed at 30 days and 12 months – an indicator paramount for increased long-term survival and exercise capacity.
- Reduced mean pressure gradient (MPG) across the valve by 85% from baseline, which remains consistent for 12 months.
- Increased blood flow velocity through the valve with stable hemodynamics from baseline, as observed at 30 days and 12 months.
- No mortality (all causes), disabling stroke, life-threatening bleeding or myocardial infarction was reported at 12 months.