Anteris kicks off U.S. patient enrollment in pivotal DurAVR heart valve trial
Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has enrolled and successfully treated the first U.S. patients in the global pivotal trial of its DurAVR® Transcatheter Heart Valve (THV) for severe calcific aortic stenosis. The procedures were performed by Dr. Azeem Latib at Montefiore Medical Center in New York, signaling the start of an aggressive recruitment push across American sites.
The milestone follows the company's recent receipt of Medicare reimbursement eligibility for procedures conducted under the PARADIGM Trial, a move that analysts say removes a significant financial barrier for participating hospitals. “After CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrollments within the week. This marks a major milestone for the PARADIGM Trial as our U.S. study sites come online and expand recruitment capability,” said Wayne Paterson, vice chairman and CEO of Anteris.
The PARADIGM Trial is a prospective, randomized controlled study designed to evaluate DurAVR THV against commercially available transcatheter aortic valve replacement (TAVR) devices. The head-to-head study is expected to enroll around 1,000 patients in its All Comers Randomized Cohort, with participants assigned on a 1:1 basis to receive either the DurAVR THV or an approved commercial valve. The primary endpoint is a composite of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure.
Dr. Latib, principal investigator and director of interventional cardiology and structural heart interventions at Montefiore, described the early procedural experience as “highly encouraging.” He added, “PARADIGM is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery. Initiating enrollment represents a critical step toward generating the evidence needed to inform future patient care.”
The broader context is significant: calcific aortic stenosis is one of the most common valvular heart diseases in aging populations, and TAVR has rapidly become a standard of care. However, questions remain about long-term durability and hemodynamic performance — areas where Anteris hopes its biomimetic valve design will differentiate itself. The DurAVR valve is engineered from a single piece of bovine pericardium, aiming to replicate natural valve leaflet motion and improve blood flow patterns.
Industry observers are watching closely. Dr. Sarah Lin, a cardiologist at the University of California, San Francisco, who is not involved in the trial, commented: “If DurAVR can demonstrate better hemodynamics and left ventricular recovery, it could shift the conversation from ‘good enough’ to ‘truly restorative.’ That would be a game-changer for younger, more active patients.”
But not everyone is convinced. Mark Tolland, a former medical device analyst and outspoken critic of some TAVR studies, was blunt: “Let’s be honest — every new valve claims to be the next big thing. The real test is whether these early procedural wins translate into meaningful outcomes at one year. I’ve seen too many promising valves stumble on long-term data. Anteris needs to prove it, not just promise it.”
Under the CMS framework, eligible procedures at participating U.S. study sites will be reimbursed under the Transcatheter Aortic Valve Replacement National Coverage Determination 20.32, operating under a Coverage with Evidence Development model. This allows reimbursement while clinical data is generated through the trial — a structure that reduces financial risk for hospitals and encourages enrollment.
With U.S. enrollment now underway, Anteris is positioned to accelerate patient recruitment and build the evidence base needed for potential regulatory submissions. The company’s ability to convert early procedural enthusiasm into robust clinical data will determine whether DurAVR can carve out a meaningful share of the multibillion-dollar TAVR market.