Medical Device Network

Further clinical success for Anteris Technologies’ biomimetic heart valve

A second valve-in-valve case adds to two early feasibility studies being conducted in the US and Europe for the device.

Anteris Technologies has revealed that a successful procedure of its DurAVR transcatheter aortic valve (THV) took place in a Canadian study as the company continues to build up positive clinical evidence for the device.

Implanted in patients as part of Health Canada’s Special Access Programme that allows life-saving technology not currently available to be used when no other treatments are suitable, the device is what Anteris claims is the world’s only balloon-expandable, single-piece THV.

The Australian medical device company recently announced the start of a US early feasibility trial (NCT05712161) in patients with aortic stenosis for the implant, which is made from a single piece of bioengineered tissue with anti-calcification properties.

The valve-in-valve procedure was conducted in a patient whose previously installed Trifecta surgical valve had degenerated. Anteris reported that after the implantation procedure with its DurAVR THV, the patient presented near-normal physiology.

Dr Janar Sathananthan, who made the request to Health Canada and is an interventional cardiologist at Vancouver General and St Paul’s Hospital, said: “Today’s case demonstrated what we saw in preclinical testing, that DurAVR THV has the potential to offer superior gradients for valve-in-valve patients. This is a great result in a small surgical valve at high risk for elevated gradients.”

Anteris is also conducting an early feasibility study in Europe (CT05182307) testing the device in patients with aortic stenosis. As per the ClinicalTrials.gov entry, the trial is expected to be completed in Q4 2023.

Anteris Technologies CEO Wayne Paterson said: “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.

"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.”

A market model by GlobalData indicates that the transcatheter aortic valve replacement market is currently worth $6.2bn, and it is forecast to reach nearly $19bn by 2033 as aortic stenosis prevalence increases. Edwards Lifesciences and Medtronic are current global leaders in the treatment space.