Anteris Reports 30-Day DurAVR THV Data From EMBARK

November 4, 2026—Anteris Technologies announced 30-day clinical and hemodynamic outcomes for its medium-size DurAVR transcatheter heart valve (THV) in 22 patients with severe aortic stenosis and medium aortic annuli enrolled in the EMBARK study.

The findings were presented by Azeem Latib, MD, during the Emerging Concepts and Innovations in TAVR session at TCT 2026 in San Diego, California.

According to the company, the mean aortic annulus area in the cohort was 492 ± 38 mm². At 30 days, the following outcomes were reported:

• Mean effective orifice area was 2.64 ± 0.19 cm², compared with 0.8 ± 0.2 cm² at baseline.
• Mean pressure gradient was 6.17 ± 1.40 mm Hg, compared with 45.5 ± 11.7 mm Hg at baseline.
• No valve-related mortality was reported.
• No moderate or severe paravalvular leak was reported.
• All patients were free from moderate or severe prosthesis–patient mismatch (PPM), as defined by Valve Academic Research Consortium-3 criteria.

“These are exceptional 30-day hemodynamics for medium annuli, with large effective orifice areas, single-digit gradients, and no moderate or severe PPM or paravalvular leak,” stated Chris Meduri, MD, Chief Medical Officer of Anteris, in the company's announcement.

The company noted in its press release that DurAVR THV is also being evaluated in the ongoing global PARADIGM pivotal trial (NCT07194265), a prospective, randomized controlled trial designed to compare its safety and effectiveness with commercially available transcatheter aortic valve replacement devices in patients with severe aortic stenosis. The trial will include use of the medium-size DurAVR THV.

PARADIGM is expected to enroll approximately 1,000 patients in its all-comers randomized cohort, with 1:1 randomization to DurAVR THV or a commercially available, approved THV. The primary endpoint is a composite of all-cause mortality, all stroke, and cardiovascular hospitalization at 1 year, with the study designed to assess noninferiority.