Anteris Technologies Announces First Successful Implantation of DurAVR™ THV in a Valve-in-Valve Procedure
July 31 2023 - 5:00AM
Business Wire
Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR), a
structural heart company developing DurAVR™ THV, a new class of
biomimetic heart valve and the world’s only balloon-expandable,
single-piece transcatheter aortic valve shaped to mimic the
performance of a native human aortic valve, announces that the
DurAVR™ THV was used for the first time in a valve-in-valve (ViV)
procedure as part of Health Canada’s Special Access Program
(SAP).
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the full release here:
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Dr Anita Asgar (centre) Co-Director of
the Structural Heart Program at the Institut de Cardiologie de
Montreal, Anteris Technologies Chief Medical Officer, Dr Chris
Meduri (far right), with the Anteris Technologies clinical team
with the DurAVR THV investigational device (Photo: Business
Wire)
A ViV procedure is required for patients with a life-threatening
situation wherein their current bioprosthetic aortic valve is
failing due to calcification or structural deterioration, and a new
heart valve must be implanted inside the failing valve. These
patients are at high risk for another surgery and require a
minimally invasive treatment option. Canada’s SAP exists so that
life-saving technology not currently available for commercial use
in Canada can be provided when no other commercially available
alternatives are suitable.
Dr. Anita Asgar, Co-Director of the Structural Heart Program at
the Institut de Cardiologie de Montreal (Montreal, Canada), made
the request to Health Canada to use the DurAVR™ THV in a patient
with a failing valve that needed optimal hemodynamic results as
well as a short frame height as they were very high risk of poor
hemodynamic result with a conventional ViV procedure. Dr. Asgar
performed the procedure on an 84-year-old male and implanted a
DurAVR™ THV inside the failed surgical aortic valve replacement
(SAVR).
The procedure was successful. The hemodynamic performance of the
valve was outstanding in such a complex patient. The patient had an
88% reduction in mean gradient which brought the patient back to a
near-normal physiologic state, with a final gradient of only 6mmHg
after deploying the valve. These results mirror what DurAVR™ THV
has seen in its extensive ViV bench-top studies.
Dr. Asgar commented:
“The DurAVR™ THV provided a life-saving solution for a patient
requiring a new valve to be implanted without compromising
hemodynamic performance or future coronary access. These
hemodynamic results are not seen with currently available products,
which is important as there is a large need for a valve that can
offer optimal hemodynamic performance in the valve-in-valve
setting, particularly with a shorter frame height. Additionally,
despite this being an incredibly complex case, using Anteris’
ComASUR™ delivery system and deploying the valve was remarkably
easy. The unique design of DurAVR™, including the low frame height
and the single-piece design, makes the valve well-suited to address
the needs of valve-in-valve patients.”
Chris Meduri, Anteris Technologies CMO, commented:
“This successful procedure further validates our extensive
pre-clinical work in valve-in-valve as well as our extensive
clinical experience in native aortic stenosis. This signals the
viability of a purpose-built valve designed to achieve life-saving
outcomes in a patient population currently treated with tradeoffs
in mind. Eliminating that compromise would be widely beneficial to
a rapidly growing population of patients whose current valve is
failing.”
About Anteris Technologies (ASX: AVR)
Anteris Technologies (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, MN – a US 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, DurAVR™ THV, is a first-in-class
biomimetic transcatheter aortic valve for the treatment of aortic
stenosis (AS). The DurAVR™ THV, in concert with the ComASUR™
Delivery System, is designed to achieve pre-disease hemodynamic
performance leading to improved clinical outcomes.
DurAVR™ THV has been designed in partnership with the world’s
leading interventional cardiologists and is the first transcatheter
aortic valve replacement (TAVR) to use a single piece of
bioengineered tissue. This first-in-class biomimetic valve is
uniquely shaped to mimic the performance of a healthy human aortic
valve.
Anteris’ patented anti-calcification ADAPT® tissue technology
has been used clinically for over 10 years and distributed for use
in over 50,000 patients worldwide.
The ComASUR™ Delivery System is designed to provide controlled
deployment and accurate placement of the DurAVR™ THV with
balloon-expandable delivery, allowing precise alignment with the
heart’s native commissures to achieve desired valve
positioning.
Aortic stenosis is a common and serious valvular heart disease.
It is the narrowing of the aortic valve, reducing blood flow from
the heart as it opens. This means the heart must work harder to
push the blood needed to function. Severe AS affects an estimated
3.4% of those aged ≥75 years in Europe and the USA.1 In Australia,
an estimated 150,000 people suffer from moderate to severe AS, with
the figure projected to climb to 200,000 by 2031 due to the aging
population.2 The global TAVR market is estimated to be USD 10
billion by 2028.
Anteris Technologies is set to revolutionize the structural
heart market by developing clinically superior solutions to meet
significant unmet clinical needs.
- Aortic Stenosis in the Elderly: Disease Prevalence and Number
of Candidates for Transcatheter Aortic Valve Replacement: A
Meta-Analysis and Modelling Study. Journal of the American College
of Cardiology, 62(11), 1002-1012.
https://doi.org/10.1016/j.jacc.2013.05.015
- Baker Heart and Diabetes Institute. (2018). Whitepaper: Our
Hidden Ageing. Retrieved from Baker Heart and Diabetes Institute:
https://baker.edu.au/impact/advocacy/valve-disease
About Valve-in-Valve
ViV procedures represent an additional, rapidly growing patient
population for the treatment of aortic stenosis. ViV procedures
have increased more than 10 times from 2014 to 2019, representing
about 6% of commercial transcatheter aortic valve replacement cases
in the U.S.1 (Garcia, 2022).
- Garcia, S. (2022, 9 18). Fracturing Bioprosthetic THVs Shows
Increased Mortality Risk, ‘Modest’ Hemodynamic Benefit, in ViV TAVR
– Analysis. Retrieved from CRTonline.org:
https://www.crtonline.org/news-detail/fracturing-bioprosthetic-thvs-shows-increased-mort
Authorization and Additional information
This announcement was authorized by Mr. Wayne Paterson, Chief
Executive Officer.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230731473162/en/
Investor Relations (U.S.) Malini Chatterjee, Ph.D.
Managing Director Blueprint Life Science Group +1 917 330 4269
Investor Relations (AU) Dejan Toracki Corporate
Development Director Anteris Technologies +61 409 340 641
Website www.anteristech.com Twitter @AnterisTech Facebook
www.facebook.com/AnterisTech LinkedIn
https://www.linkedin.com/company/anteristech
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