Brisbane medtech manufacturer Anteris Technologies has announced positive 12-month results from the first-in Human (FIH) study designed to evaluate the safety and efficacy of its DurAVR aortic valve replacement device (pictured) in patients with symptomatic severe aortic stenosis.
DurAVR is a new class of aortic valve that utilises the company’s patented ADAPT anti-calcification process and tissue-shaping technology in what is said to be the world’s first single-piece trans-catheter inserted heart valve.
The device’s design replicates the normal blood flow of a healthy human aortic valve.
According to a statement the device restored normal, pre-disease blood flow, producing large effective orifice areas (EOA), enabling the valve to open widely with low mean pressure gradients (MPG).
Fewer sutures are necessary in the procedure, preserving tissue integrity and reducing stresses with longer coaptation – the process drawing together separated body tissues.
The first five patients implanted with DurAVR continue to show stable, improved valve function according to Anteris.
Anteris CEO Wayne Paterson said the trial was a major clinical milestone for the company.
Patereson said: “This strong safety and hemodynamic data for DurAVRat 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 demonstrates its singlepiece 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.”
There was no mortality, stroke, myocardial infarction or life-threatening bleeding seen in the results.
Picture: Anteris Technologies