Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has secured US Medicare reimbursement eligibility for eligible procedures in its global pivotal PARADIGM Trial, a prospective, randomised controlled study designed to evaluate the safety and effectiveness of Anteris’ DurAVR® Transcatheter Heart Valve against commercially available TAVR devices.
The head-to-head trial is expected to enrol around 1,000 patients in its All Comers Randomized Cohort, with participants assigned on a 1:1 basis to receive either DurAVR® THV or an approved commercial transcatheter heart valve.
The trial will assess non-inferiority against a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at one year after the procedure.
The structural heart company said eligible procedures at participating US study sites will be covered under the Centers for Medicare & Medicaid Services’ Transcatheter Aortic Valve Replacement National Coverage Determination 20.32.
The reimbursement framework operates under a Coverage with Evidence Development model, allowing Medicare reimbursement while clinical evidence is generated through the PARADIGM Trial.
Anteris said the milestone is expected to support US site activation and accelerate operational momentum across participating centres.
About Anteris
Anteris is a global structural heart company developing medical devices aimed at restoring healthy heart function.
Founded in Australia and with a significant presence in Minneapolis, the company is led by a multidisciplinary team focused on restorative solutions for patients with structural heart disease.
Its lead product, the DurAVR® Transcatheter Heart Valve, has been developed to treat aortic stenosis. The balloon-expandable valve is designed to mimic the performance of a healthy human aortic valve and support more natural blood flow.
DurAVR® is made from a single piece of moulded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology, which has been used clinically for more than 10 years and distributed for use in more than 55,000 patients worldwide.