Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has unveiled promising new data from the first-in-human (FIH) study of its DurAVR™ transcatheter heart valve (THV), which is designed to mimic the native human aortic valve.
This innovative balloon-expandable, single-piece biomimetic valve has shown optimal performance when deployed with the ComASUR™ Delivery System.
Successful implantation
The latest cohort of 13 patients, all successfully implanted with the DurAVR™ THV, was crucial in confirming the performance of the ComASUR™ Delivery System before kicking off the pivotal Phase 3 registration study for DurAVR™ THV.
This system allowed for controlled deployment and precise alignment of the DurAVR™ THV with patients' native aortic valves, demonstrating improved haemodynamic performance compared to earlier cohorts.
The 30-day data from Cohort 5 highlighted significant improvements in key haemodynamic parameters, including effective orifice area (42% increase), mean pressure gradient (35% decrease) and Doppler velocity index (41% improvement).
Market-leading haemodynamics
CEO Wayne Paterson said: "The DurAVR™ THV and the ComASUR™ Delivery System were designed in partnership with our medical advisory board to deliver a highly differentiated, new class (biomimetic) of valve which can be easily deployed via a balloon expandable platform.
“This latest data confirms the DurAVR™ THV System (valve and delivery system) can deliver market-leading haemodynamic performance in an intuitive, easy to use, balloon expandable platform."
About Anteris
Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF), based in Australia with a significant presence in Minneapolis, USA, is committed to revolutionising the structural heart market with innovative medical devices.
The DurAVR™ THV, created in collaboration with leading cardiologists and surgeons, is the first transcatheter aortic valve replacement (TAVR) using a single piece of bioengineered tissue.
The valve, made with Anteris' patented ADAPT® anti-calcification tissue technology, has been used in over 55,000 patients globally.
The ComASUR™ Delivery System is designed for precise deployment and alignment, ensuring optimal valve positioning.
Anteris Technologies aims to address significant unmet clinical needs in the structural heart market with clinically superior solutions.