Anteris Provides Update on DurAVR™ THV Valve-in-Valve Experience Presented at New York Valves 2024
13 June 2024 - 8:00PM
Business Wire
DurAVR ViV restores similar aortic valve gradients to initial
post-surgical results
Anteris Technologies Ltd (ASX: AVR), a structural heart company
developing DurAVR™ THV, a new class of TAVR 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 Anita Asgar, Institut de Cardiologie de Montreal, presented a
series of cases from five high-risk patients who underwent
valve-in-valve (ViV) procedures using DurAVR™ THV. The patients
were treated under Health Canada’s special access program (SAP)
which allows health care professionals to access unlicensed medical
devices, such as DurAVR™, for emergency use when conventional
therapies have failed, are unavailable, or are unsuitable to treat
a patient.
Unique Challenges of ViV Procedures
While TAVR procedures have revolutionized heart valve
replacement, up to 30% of patients may eventually require a second
valve due to deterioration of the first implant1. Transcatheter ViV
replacement is performed by implanting a transcatheter heart valve
within a failing bioprosthetic aortic valve. The transcatheter ViV
operation is a less invasive procedure compared with reoperative
surgical aortic valve replacement however this repeat procedure
presents unique challenges for both doctors and patients.
"Valve-in-valve procedures often force us to make difficult
choices," explained Dr. Asgar. "Current TAVR devices may limit
optimal valve function (hemodynamics) for these very sick patients,
while others are operationally challenging to ensure access to
coronary arteries."
Restoring Valve Hemodynamics with DurAVR™
ViV implantation with DurAVR™ THV successfully reduced aortic
valve gradients to a level similar to the initial post-surgical
valve gradient.
Average aortic valve gradients across the series of 5
cases:
- Post-surgical valve replacement gradient (8-13 years prior)
= 13.82 mmHg
- Mean gradient prior to ViV = 58.60 mmHg
- 30 day core lab echo data post DurAVR™ ViV = 13.76
mmHg
No major complications were reported.
Dr Asgar commented “This data set of valve-in-valve patients
highlights the impact of the DurAVR™ valve biomimetic design by
restoring these patients’ hemodynamics to the performance of their
initial surgical valve and is very encouraging for the wave of
valve-in-valve patients that are coming in the future.”
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 Mr. Wayne Paterson, Chief
Executive Officer.
Website
www.anteristech.com
Twitter
@AnterisTech
Facebook
www.facebook.com/AnterisTechnologies
LinkedIn
https://www.linkedin.com/company/anteristech
- Giordana, F., Bruno, F., Controtto, F. et al. Incidence,
predictors and outcomes of valve-in-valve TAVI: A systematic review
and meta-analysis. Int. J. Cardiol. 316 (2020).
https://doi.org/10.1016/j.ijcard.2020.05.058
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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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