DurAVR™ THV Demonstrates Exceptional Results in Second Valve-in-Valve Case
August 14 2023 - 5:00AM
Business Wire
Anteris Technologies Ltd (Anteris or the Company) (ASX: AVR,
OTC: ANTTY) reported today that DurAVR™ THV, a new class of
biomimetic heart valve and the world’s only balloon-expandable,
single-piece transcatheter aortic valve was implanted in a second
successful Valve-in-Valve (ViV) procedure as part of Health
Canada’s Special Access Program (SAP).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230814475610/en/
Dr. Janar Sathananthan with his team from
St. Paul’s Hospital, Vancouver alongside Anteris Technologies
Clinical team. (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. Currently available commercial
products can leave patients with a high risk of remaining in a
diseased state post-procedure, with unsatisfactory high gradients.
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 Janar Sathananthan, an interventional cardiologist at
Vancouver General and St Paul’s Hospital and a world expert on
bench testing the hemodynamic effects of different valves used in
ViV procedures, made the request to Health Canada to make DurAVR™
THV available for this procedure.
DurAVR™ THV was implanted in a 79-year-old female who was
previously implanted with a Trifecta surgical valve that had
severely degenerated, causing debilitating symptoms. The
intraoperative results after DurAVR™ THV was implanted were
phenomenal, with a mean pressure gradient of 7mmHg, restoring
near-normal physiology. The patient was safely discharged less than
24 hours after the procedure.
Dr. Sathananthan commented:
“DurAVR™ THV performed exceptionally well during this complex
ViV procedure. Today’s case demonstrated what we saw in preclinical
testing, that DurAVR™ THV has the potential to offer superior
gradients for ViV patients. This is a great result in a small
surgical valve at high risk for elevated gradients.”
Dr. Chris Meduri, Anteris Technologies CMO,
Commented:
“DurAVR™ THV has been purposely designed in close partnership
with the world’s leading TAVR physicians as a solution to achieve
near-normal blood flow. As we continue to progress and build the
body of clinical evidence for the DurAVR™ THV system, we believe
that the unique design of this valve is behind the exceptional
best-in-class results and will be the ideal choice for patients
with both native severe aortic stenosis and those needing a ViV
procedure. As Dr. Sathananthan has stated, these results do not
come as a surprise. Extensive preclinical work in partnership with
a large number of leading physicians has demonstrated a superior
hemodynamic result compared to commercially available products,
both in native aortic stenosis and in valve-in-valve procedures.
With a rapidly growing number of degenerating AVRs, this valve will
have a dominant role in treating these patients.”
Wayne Paterson, Anteris Technologies CEO Commented:
“As the body of evidence is growing rapidly with our Europe and
North American patients, we are seeing results that support both
the clinical and commercial case for DurAVR™ THV. These outstanding
results are not only best in class but deliver options for patients
that were previously not seen with existing products. Our continued
clinical success both in the treatment of native aortic stenosis
patients as well as the complicated and difficult-to-treat
valve-in-valve patients is building confidence within the global
physician community. With the recent global withdrawal of an aortic
valve replacement product due to accelerated failure leaving tens
of thousands of patients with a deteriorating valve, there is a
rapidly growing need for better treatment options for this specific
patient group which may account for 30% (USD 3 BN) in the years
ahead.”
DurAVR™ THV continues to be investigated in a clinical trial
setting for severe aortic stenosis patients in two Early
Feasibility Studies (EFS) being run in the US (ClinicalTrials.gov
NCT05712161) and Europe (Clinicaltrials.gov NCT05182307) at this
time.
About Anteris Technologies (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, DurAVR™, is a transcatheter heart
valve (THV) for the treatment of aortic stenosis. DurAVR™ THV has
been designed in partnership with the world’s leading
interventional cardiologists and cardiac surgeons, and 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.
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.
Anteris Technologies is set to revolutionise the structural
heart market by delivering clinically superior solutions that meet
significant unmet clinical needs.
Authorization and Additional information
This announcement was authorised by the Board of Directors.
For more information:
Website www.anteristech.com Twitter @AnterisTech Facebook
www.facebook.com/AnterisTech LinkedIn
https://www.linkedin.com/company/anteristech
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230814475610/en/
Investor Relations (U.S.) Malini Chatterjee, Ph.D.
Managing Director Blueprint Life Science Group +1 917 330 4269
Investor Relations Dejan Toracki Corporate Development
Director Anteris Technologies +61 409 340 641
Avaron Mining (TSXV:AVR)
Historical Stock Chart
From Oct 2024 to Nov 2024
Avaron Mining (TSXV:AVR)
Historical Stock Chart
From Nov 2023 to Nov 2024