Anteris Launches Global Trial for Innovative DurAVR Heart Valve

Anteris Advances Clinical Milestone

Anteris Technologies Global Corp. has taken a significant step forward in its mission to revolutionize treatment for severe calcific aortic stenosis by enrolling and successfully treating the first patients in its global pivotal PARADIGM Trial. This randomized controlled trial (RCT) is designed to evaluate the safety and effectiveness of Anteris’ DurAVR Transcatheter Heart Valve (THV) against commercially available transcatheter aortic valve replacements (TAVRs).

The initial procedures were performed at Rigshospitalet, Copenhagen University Hospital, under the care of Prof. Dr. Ole De Backer, who expressed optimism about the device’s potential to transform patient care. The PARADIGM Trial represents a critical phase in Anteris’ clinical development, aiming to provide robust comparative evidence across all surgical risk groups.

Trial Design and Strategic Importance

The PARADIGM Trial will enroll approximately 1,000 patients worldwide, randomized 1, 1 to receive either the DurAVR THV or an approved commercial TAVR. Its primary endpoint focuses on a composite of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure. This head-to-head comparison is expected to generate Level 1 evidence, the gold standard in clinical research, which is essential for regulatory approval and market acceptance.

Anteris plans to expand the trial across the United States, Europe, and Canada, leveraging strong investigator enthusiasm to accelerate recruitment and study progression. The company’s confidence is bolstered by prior clinical data involving 130 patients treated with DurAVR, including complex cases such as valve-in-valve and bicuspid aortic valve anatomies.

Innovative Technology Behind DurAVR

DurAVR distinguishes itself through its biomimetic design, crafted to replicate the natural function of a healthy aortic valve. It incorporates Anteris’ patented ADAPT tissue technology, a single-piece molded tissue that has been FDA-cleared and used in over 55,000 patients globally. This anti-calcification tissue aims to enhance durability and patient outcomes, potentially setting DurAVR apart in a competitive market.

The balloon-expandable DurAVR valve is delivered via the ComASUR Delivery System, designed for ease of use and procedural efficiency. As the trial progresses, the medical community will be watching closely to see if these technological advantages translate into superior clinical results.

Looking Ahead

With the PARADIGM Trial underway, Anteris is positioned to generate the high-quality clinical evidence necessary for regulatory submissions and eventual commercialisation. Success in this trial could expand treatment options for patients with aortic stenosis and challenge established players in the transcatheter valve market. However, the path ahead remains contingent on trial outcomes and regulatory review timelines.