HI all AVR'ers
Putting the up coming trials aside, any thoughts on the continuation/when needed etc.. of the Health Canada special access program... whilst the trial are in train?
I believe there is a great opportunity for continuation of this. Now maybe I missed some report - possible. Thanks all.
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ASX ANNOUNCEMENT
22 January 2024
Three Difficult to Treat DurAVR™ Valve-in-Valve Patients Completed
under Health Canada’s Special Access Program
Anteris Technologies Ltd (ASX: AVR), a structural heart company committed to designing, developing,
and commercialising innovative medical devices, is pleased to announce the successful completion of
three new valve-in-valve (ViV) cases using DurAVR™, a first-in-class biomimetic transcatheter heart
valve.
These are the 4th- 6th patients treated with DurAVR™ 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. The approval is based on multiple factors including past patient outcomes, safety data and
physician support.
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.
Dr Anita Asgar, Institut de Cardiologie de Montreal, commented, ‘‘The challenges we face as clinicians
is the need to preserve coronary access, but these are also patients who are also reasonably active, and
we need to give them a good haemodynamic result, we need to really improve their symptoms so they
can have a good quality of life”.
Dr Asgar, who performed the procedures, stated, “As a clinician, it’s a great opportunity to have access
to a technology that may help us with what is probably going to be a tsunami of valve-in-valve procedures
that we are going to have to do”.
"These patients are in a challenging situation and are in need of a better option than what is commercially
available. DurAVR™ delivered an outstanding result with meaningful patient benefits".
Wayne Paterson CEO commented, “With an increasing number of bioprosthetic valves failing in patients
it’s important that we study the effects of DurAVR™ in this patient population to better understand if the
best-in-class results we see in newly treated aortic stenosis is also seen in this difficult to treat population.
We are pleased with the results to date and will continue to study this group who have limited treatment
options today”.
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