Anteris receives first European regulatory clearance to commence DurAVR trial

Anteris Technologies (AVR) announced it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR Transcatheter Heart Valve, THV, global pivotal trial in patients with severe calcific aortic stenosis. Patient recruitment at Danish centers is expected to begin in 4Q 2025. “Receiving initial approval in Europe is an important milestone as it signals the launch of the global PARADIGM Trial. This groundbreaking study has been designed with world-leading experts and is attracting significant interest from clinicians globally, reflecting the potential for DurAVR to transform care for patients with aortic stenosis,” said Anteris Chief Medical Officer, Chris Meduri, M.D.