Anteris Secures FDA Green Light for Global DurAVR Heart Valve Trial

Anteris Technologies (ASX: AVR, NASDAQ: AVR) has achieved a significant regulatory milestone, receiving approval from the US Food and Drug Administration (FDA) to commence its global pivotal trial of the DurAVR Transcatheter Heart Valve (THV), known as the PARADIGM Trial.

The trial will assess the safety and effectiveness of the DurAVR valve—a first-of-its-kind biomimetic heart valve engineered to mimic the form and function of a healthy human aortic valve—in patients with severe calcific aortic stenosis. This global study will provide the critical clinical data required to support a future Premarket Approval (PMA) submission in the United States.

“This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide,” said Anteris Vice Chairman and CEO, Wayne Paterson.

The PARADIGM Trial, a randomised controlled study, will enrol approximately 1000 patients across the United States, Europe and Canada. Patients will be assigned on a one-to-one basis to receive either the DurAVR valve or a commercially available transcatheter aortic valve replacement (TAVR). The study’s primary composite endpoint includes all-cause mortality, stroke and cardiovascular-related hospitalisations within one year post-procedure.

This head-to-head design will directly compare Anteris’ DurAVR against existing TAVR technologies. The DurAVR valve is built using the company’s ADAPT tissue technology, which has already been used in over 55,000 patients globally. The valve is delivered via Anteris’ proprietary ComASUR balloon-expandable system.

Co-chaired by two globally respected clinicians—Dr Michael Reardon of Houston Methodist Hospital in Texas and Professor Stephan Windecker of Bern University Hospital in Switzerland—the trial is expected to position DurAVR as a potential game-changer in the structural heart space.

DurAVR is designed to address limitations of current valves by restoring more natural blood flow through the aortic valve, potentially improving long-term outcomes for patients with aortic stenosis, a condition marked by narrowing of the aortic valve that can lead to heart failure if untreated.

Anteris is advancing the PARADIGM Trial in parallel with its CE Mark pathway for European market approval. The FDA authorisation follows successful early patient implants in Denmark, marking the beginning of global enrolment.