Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has reached a key clinical milestone, announcing that the first patients have been successfully treated in its global PARADIGM pivotal trial for the DurAVR® transcatheter heart valve (THV).
The procedures — performed at The Heart Centre at Rigshospitalet Copenhagen University Hospital in Denmark — mark the formal start of what the company describes as a landmark head-to-head study comparing its biomimetic DurAVR valve against commercially available transcatheter aortic valve replacements (TAVRs).
Prof. Dr Ole De Backer, who led the first cases, said the initial experience had been “very positive”.
“We are proud to be the first enrolling centre for this important trial,” he said. “Our initial experience with the DurAVR THV System has been very positive, and we look forward to providing definitive comparative evidence which could transform patient care.”
Building towards commercialisation
Anteris chief medical officer Dr Chris Meduri said the trial’s commencement moves the company closer to generating the pivotal data required to support commercial rollout.
“With the first patients now randomised in the PARADIGM Trial, we are actively generating the clinical evidence required to advance the DurAVR THV toward commercialisation, expanding treatment options for aortic stenosis patients,” Dr Meduri said.
“This head-to-head study will provide robust comparative evidence across all surgical risk groups, which we believe will differentiate our platform based on efficacy, safety and ease of use.”
The PARADIGM Trial builds on data from 130 patients already treated with DurAVR, spanning first-time aortic stenosis cases, valve-in-valve procedures and complex anatomies such as bicuspid aortic valves.
Anteris plans to expand the trial across the United States, Europe and Canada, targeting efficient recruitment through what management says is strong investigator enthusiasm.
Read more: Anteris secures first European green light to start PARADIGM pivotal trial of DurAVR THV
About the PARADIGM trial
The study is a prospective, randomised controlled trial evaluating DurAVR against currently approved TAVR systems. Around 1,000 patients will be enrolled in the ‘All-Comers Randomised Cohort’, with one-to-one randomisation between the two valve types.
The primary endpoint will assess non-inferiority at one year post-procedure based on a composite of all-cause mortality, all stroke and cardiovascular hospitalisation.
About Anteris
Founded in Australia and headquartered in Brisbane with operations in Minneapolis, Anteris is developing next-generation structural heart solutions.
Its flagship DurAVR THV — the first biomimetic aortic valve designed to mimic the performance of a healthy human valve — is made from a single piece of moulded ADAPT® tissue, the company’s patented, US Food and Drug Administration (FDA)–cleared anti-calcification technology that has been used in more than 55,000 patients worldwide.
The DurAVR system combines this valve with the ComASUR® balloon-expandable delivery platform, targeting improved durability and haemodynamic performance for patients with severe calcific aortic stenosis.