Anteris Technologies (ASX:AVR) has received U.S. Food and Drug Administration (FDA) approval to begin its global pivotal PARADIGM Trial, a randomised study evaluating the company’s DurAV Transcatheter Heart Valve (THV) for patients with severe calcific aortic stenosis.
The PARADIGM trial will enrol approximately 1,000 patients across the United States, Europe and Canada. It will compare Anteris’ biomimetic valve directly with leading commercial transcatheter aortic valve replacement (TAVR) devices, assessing outcomes including mortality, stroke, and cardiovascular hospitalisation at one year.
Anteris Chief Executive Officer Wayne Paterson described the FDA approval as a pivotal milestone for the Australian-founded company. “This represents a significant step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition,” he said.
The PARADIGM trial is co-chaired by Dr Michael Reardon of Houston Methodist Hospital and Professor Stephan Windecker of Bern University Hospital, two of the world’s leading authorities in structural heart research.
The DurAVR THV system is the first biomimetic valve designed to replicate the natural function of a healthy human aortic valve, utilising ADAPT tissue, Anteris’ patented anti-calcification technology, which has been used in more than 55,000 patients globally.
The valve’s single-piece moulded design aims to restore natural blood flow while minimising calcification and improving long-term durability.
The company said the trial will generate the Level 1 evidence required for a Premarket Approval (PMA) submission to the FDA, with parallel progress toward CE Mark approval in Europe.
Founded in Australia and now operating across Brisbane, Minneapolis, Geneva and Malaga, Anteris is positioning DurAVR as a transformative technology in the global structural heart market. The FDA approval of PARADIGM positions the company among a select group of innovators advancing next-generation valve replacement technologies designed for optimal physiological performance and long-term durability.