Anteris Provides Data Update on First in Human Study of DurAVR™ THV Presented at New York Valves 2024
11 June 2024 - 8:00PM
Business Wire
Anteris Technologies Ltd (ASX: AVR), a structural heart company
developing DurAVR™ THV, a new class of TAVI and the world’s only
balloon-expandable, single-piece biomimetic aortic replacement
valve shaped to mimic the native human valve, today announced a
summation of the Company’s presentation at the New York Valves
annual Conference held at the Jacob K. Javits Convention Center in
New York City.
Dr João Cavalcante, Section Head, Cardiac Imaging, Allina Health
Minneapolis Heart Institute and Scientific Director, Cardiovascular
Imaging Core Lab and Research Center, presented new cardiac MRI
data from the DurAVRTM THV First-in-Human (FIH) Study. The findings
showed the restoration of normal flow and hemodynamics, leading to
significant left ventricular mass regression in patients with
symptomatic, severe aortic stenosis.
DurAVRTM THV demonstrated excellent post-procedure hemodynamic
results in 41 patients, 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 hemodynamic results resemble those seen
in healthy subjects. Dr Cavalcante commented that the current
market-leading balloon-expandable valve would be unable to achieve
these results in small annuli patients (mean annulus size:
22.57mm), before proceeding to explain the clinical relevance of
healthy flow dynamics beyond traditional echo gradients.
Dr Cavalcante explained that aortic stenosis is not just a
disease of the valve, it is also a disease of the arteries and the
myocardium. In normal healthy aortic flow, the flow is laminar;
there is little-to-no flow displacement (FD), the flow is
non-eccentric and there is limited-to-no flow reversal (FRR) even
in systole (when the ventricle contracts). Using cardiac MRI data
courtesy of Dr Pankaj Garg, Dr Cavalcante explained the same
phenomenon could be seen with DurAVRTM THV, which restored laminar
flow with near equivalence to a normal healthy aortic valve.
Studies performed on commercially available transcatheter valves,
either balloon-expandable or self-expanding, do not appear to
restore normal aortic flow.
- Normal Healthy Aortic Valve: FD = 10%, FRR = 1% (n=5)
- DurAVRTM THV: FD = 15%, FRR = 5% (n=11)
- Severe AS: FD = 46%, FRR = 23%
- Edwards Sapien 3: FD = 48%, FRR = 35%
- Medtronic Evolut R: FD = 25%, FRR = 4%
- CEP Magna Ease: FD = 27%, FRR = 30%
Dr Cavalcante commented, “When we look at commercially available
surgical or TAVR valves, we are still seeing abnormal flow patterns
on cardiac MRI. The restoration of laminar flow, as we are seeing
with this new DurAVRTM THV, is a byproduct of the intrinsic valve
design and novel technology, which might have positive downstream
implications to the arteries and consequently to ventricle, and
ultimately to the patients.”
Dr Cavalcante also reported that in patients treated with
DurAVRTM THV, cardiac MRI also detected a significant left
ventricular mass index regression at 6 months post-TAVR. A recent
meta-analysis1 of other TAVR platforms demonstrated an average LV
mass index regression of around 15 g/m2, in comparison to DurAVRTM
THV, which demonstrated a difference of almost 20 g/m2.
The full downstream effect of restoring laminar flow will need
to be further studied and validated in ongoing and future studies,
including a larger pivotal imaging sub-study.
About Anteris Technologies Ltd (ASX: AVR)
Anteris Technologies Ltd (ASX: AVR) is a structural heart
company committed to designing, developing, and commercialising
innovative medical devices. Founded in Australia, with a
significant presence in Minneapolis, USA (a MedTech hub), Anteris
is science-driven, with an experienced team of multidisciplinary
professionals delivering transformative solutions to structural
heart disease patients.
The Company’s lead product, DurAVRTM, is a transcatheter heart
valve (THV) for treating aortic stenosis. DurAVRTM THV was designed
in partnership with the world’s leading interventional
cardiologists and cardiac surgeons. It is the first transcatheter
aortic valve replacement (TAVR) to use a single piece of
bioengineered tissue. This biomimetic valve is uniquely shaped to
mimic the performance of a healthy human aortic valve.
DurAVRTM THV is made using ADAPT® tissue, Anteris’ patented
anti-calcification tissue technology. ADAPT® tissue has been used
clinically for over 10 years and distributed for use in over 55,000
patients worldwide.
The ComASURTM Delivery System was designed to provide controlled
deployment and accurate placement of the DurAVRTM THV with
balloon-expandable delivery, allowing precise alignment with the
heart’s native commissures to achieve optimal valve
positioning.
Anteris Technologies is set to revolutionise the structural
heart market by delivering clinically superior solutions for
significant unmet clinical needs.
Authorisation and Additional information
This announcement was authorised by the Board of Directors.
Website www.anteristech.com Twitter @AnterisTech Facebook
www.facebook.com/AnterisTechnologies LinkedIn
https://www.linkedin.com/company/anteristech
1 Mehdipoor, G., Chen, S., Chatterjee, S. et al. Cardiac
structural changes after transcatheter aortic valve replacement:
systematic review and meta-analysis of cardiovascular magnetic
resonance studies. J Cardiovasc Magn Reson 22, 41 (2020).
https://doi.org/10.1186/s12968-020-00629-9
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Investor Relations investors@anteristech.com Anteris
Technologies Ltd +61 1300 550 310 | +61 7 3152 3200
Investor Relations (US) Malini Chatterjee, Ph.D. Managing
Director Blueprint Life Science Group +1 917 330 4269
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