Anteris Technologies recently shared groundbreaking findings from their DurAVR™ THV First-in-Human Study at the prestigious New York Valves annual Conference. Dr João Cavalcante, a renowned expert in cardiac imaging, presented new cardiac MRI data that demonstrated the remarkable ability of DurAVR™ THV to restore normal flow and hemodynamics in patients with symptomatic, severe aortic stenosis.
The study, which included 41 patients, showed that DurAVR™ THV achieved excellent post-procedure hemodynamic results, with large effective orifice areas (2.20 cm2), single-digit mean gradients (8.5 mmHg), and a Doppler Velocity Index (DVI) of 0.62. These results closely resemble those seen in healthy subjects, a feat that current market-leading balloon-expandable valves would be unable to achieve in patients with small annuli (mean annulus size: 22.57mm).
Dr Cavalcante emphasized that aortic stenosis affects not only the valve but also the arteries and the myocardium. In a healthy aortic valve, the flow is laminar, with minimal flow displacement, non-eccentric flow, and limited flow reversal even during systole. Using cardiac MRI data, Dr Cavalcante demonstrated that DurAVR™ THV restored laminar flow to a level nearly equivalent to that of a normal, healthy aortic valve. In contrast, studies on commercially available transcatheter valves, both balloon-expandable and self-expanding, did not appear to restore normal aortic flow.
The study also revealed that patients treated with DurAVR™ THV experienced significant left ventricular mass index regression at 6 months post-TAVR. While a recent meta-analysis of other TAVR platforms showed an average LV mass index regression of around 15 g/m2, DurAVR™ THV demonstrated a difference of almost 20 g/m2.
Anteris Technologies Ltd, founded in Australia with a significant presence in the MedTech hub of Minneapolis, USA, is committed to designing, developing, and commercializing innovative medical devices. Their lead product, DurAVR™ THV, is a transcatheter heart valve designed to treat aortic stenosis. Developed in collaboration with world-leading interventional cardiologists and cardiac surgeons, DurAVR™ THV is the first transcatheter aortic valve replacement to use a single piece of bioengineered tissue, uniquely shaped to mimic the performance of a healthy human aortic valve.
DurAVR™ THV is made using ADAPT® tissue, Anteris' patented anti-calcification tissue technology, which has been used clinically for over a decade and distributed for use in more than 55,000 patients worldwide. The ComASUR™ Delivery System, designed to provide controlled deployment and accurate placement of the DurAVR™ THV with balloon-expandable delivery, allows precise alignment with the heart's native commissures for optimal valve positioning.
The full downstream effect of restoring laminar flow will require further study and validation in ongoing and future research, including a larger pivotal imaging sub-study. However, the initial findings from the DurAVR™ THV First-in-Human Study suggest that Anteris Technologies is poised to revolutionize the structural heart market by delivering clinically superior solutions for significant unmet clinical needs.
ASX: AVR
Price: A$15.75
Change: + 6.78%
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