Anteris Technologies marks clinical milestone with more than 100 patients treated using flagship DurAVR® THV

Anteris Technologies Global Corp has topped the 100-patient mark, with more than that number now treated globally using its DurAVR® Transcatheter Heart Valve (THV) in the treatment of severe aortic stenosis.

To date, the biomimetic valve has been used across a broad spectrum of cases, including first-time aortic stenosis, valve-in-valve procedures and patients with complex anatomies such as bicuspid aortic valves.

Primary endpoints met

Sixty-five patients have successfully completed the primary endpoint measures for safety and efficacy at 30 days, while one-year data from 37 patients continues to demonstrate sustained hemodynamic benefits, including large effective orifice areas and low pressure gradients.

There are a range of valve sizes available to accommodate a broad patient population, and the valve has maintained an excellent safety profile, with no valve- or cardiovascular-related mortality reported at one year.

Anteris remains on track to commence its pivotal DurAVR® THV trial in the third quarter of 2025, subject to approval from the United States Food and Drug Administration (FDA).

The DurAVR® THV is the first biomimetic heart valve of its kind, designed to replicate the performance of a healthy human aortic valve.

It is constructed using Anteris’ patented ADAPT® tissue, a single-piece, anti-calcification tissue technology already cleared by the FDA and used in over 55,000 patients worldwide.

Anteris chief medical officer Chris Meduri MD said: “We are incredibly proud to have reached this milestone, which represents years of dedication, research, and importantly collaboration with expert physicians in the field.

“The excellent hemodynamic performance we are seeing is noteworthy in that it shows that DurAVR® has the potential to restore natural heart valve function and thereby redefine what success looks like in the treatment of aortic stenosis.”

Strong foundation of clinical evidence

“We are building on a strong foundation of clinical evidence, and we remain committed to rigorous scientific evaluation as we progress toward the all-risk, head-to-head, DurAVR® registration trial,” Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital and Study Chair of the DurAVR® THV Pivotal Trial Dr. Michael Reardon said.

“This is a clinical milestone for the company and its investors,” Vice chair and CEO Wayne Paterson said.

“Not only have we crossed the threshold of having treated over 100 patients, but we have achieved results that are clinically relevant and significantly differentiated to current therapies.

“DurAVR® is the first new class of product in this space in many years and the current results across often complex patients confirms the value of the product for physicians and patients as we move into our registration trial this year.”