Anteris Technologies (Nasdaq:AVR) announced today that it received clearance to begin a trial of its DurAVR heart valve system.
The Danish Medicines Agency gave Anteris the green light to evaluate its transcatheter heart valve (THV) in patients with severe calcific aortic stenosis. It expects to begin recruitment for the PARADIGM trial at Danish centers in the fourth quarter of 2025.
PARADIGM assesses the safety and effectiveness of DurAVR, a biomimetic valve, compared to commercial TAVR devices. Clearance for the trial in Denmark marks the first for PARADIGM. The company expects to add further countries and sites in the near-term, including in the U.S., Canada and elsewhere in Europe.
“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 Dr. Chris Meduri.
More about Anteris and its valve technology
Brisbane, Australia-based Anteris — which has U.S. operations in Minneapolis — designed TurAVR THV as a new class of biomimetic heart valve. The company says it’s the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic a native human aortic valve’s performance.
Balloon-expandable delivery enables precise alignment with the heart’s native commissures, achieving desired valve positioning.
The company reported a first successful implant of the valve more than two years ago. It launched an IPO in late 2024 to further advance the development of the valve. Anteris expects investigational device exemption (IDE) approval from the FDA in the near future to enable U.S. studies.
“The PARADIGM trial is a multi center global study which, if successful, will result in multiple approvals and labels for the DurAVR THV. This is a watershed moment in the company’s life cycle and marks the beginning of the commercialization planning phase as we march towards global approvals,” said Wayne Paterson, Anteris vice chair and CEO. “Anteris is excited to be able to allow access to an increasing pool of patients globally who will benefit from this life saving technology. The commencement of this trial reflects the commitment and tireless work of our talented Anteris team, as well as our physician and scientific advisors.
“The company would like to express its gratitude to the physicians, patients and shareholders who have been fundamental in developing this important new therapy.”
