Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) is celebrating the successful implantation of its new class of biomimetic valves, the world’s only balloon-expandable, single-piece transcatheter aortic valve, in a Valve-in-Valve (ViV) procedure as part of Health Canada’s Special Access Program (SAP).
A ViV procedure is used for patients in life-threatening situations, when 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.
Dr Janar Sathananthan, an interventional cardiologist at Vancouver General and St Paul’s Hospital and a world expert on bench testing the effects of different valves used in ViV procedures, made the request to Health Canada to make DurAVR™ THV available for this procedure.
“DurAVR™ THV performed exceptionally well during this complex ViV procedure,” Dr Sathananthan said, “Today’s cases demonstrated what we saw in preclinical testing, that DurAVR™ 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.”
Novel design accounts for exceptional results
“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,” Anteris Technologies chief medical officer Dr Chris Medur said.
“As we continue to progress and build the body of clinical evidence for the DurAVR™ 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.”
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).
Growing need for better options
“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,” Anteris Technologies CEO Wayne Paterson said.
“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% in the years ahead.”