Anteris reports a 6.17 mmHg mean gradient in 22 medium-annulus DurAVR patients

MedDevice Startups Staff · 4 days ago · 2 min read · Via Anteris release

Anteris Technologies Global Corp reported 30-day results for the medium size of its DurAVR transcatheter heart valve. The cohort covered 22 patients with severe aortic stenosis and a mean annulus area of 492 mm2. Mean pressure gradient fell to 6.17 mmHg from 45.5 mmHg at baseline. Effective orifice area rose to 2.64 cm2 from 0.8 cm2.

No patient had moderate or severe paravalvular leak. None had moderate or severe prosthesis-patient mismatch. Anteris reported no valve-related deaths. Azeem Latib presented the data at TCT 2026 in San Diego on November 1, in a session on emerging concepts and innovations in TAVR.

DurAVR is built from a single piece of the company's ADAPT bioengineered tissue. The valve is investigational and is not sold anywhere in the world. The ADAPT tissue carries FDA clearance on its own, and that clearance does not extend to the valve.

Medium and small annuli are where current valves leave the least hemodynamic room, so a gradient near 6 mmHg is the result Anteris needed from this size. Twenty-two patients will not settle anything, and the company still has a randomized study ahead of it.

Questions & Answers

What did Anteris report for the medium-size DurAVR valve at TCT 2026?

Anteris Technologies reported 30-day outcomes in 22 patients with severe aortic stenosis and a mean annulus area of 492 mm2. Mean pressure gradient was 6.17 mmHg and effective orifice area was 2.64 cm2, with no moderate or severe paravalvular leak and no moderate or severe prosthesis-patient mismatch.

Is the Anteris DurAVR transcatheter heart valve approved by FDA?

No. As of November 1, 2026, Anteris describes DurAVR as investigational and not available for commercial use or sale worldwide. The ADAPT tissue used to build the valve is FDA cleared, but that clearance does not cover the DurAVR valve itself.

Who presented the Anteris medium-size DurAVR data?

Azeem Latib presented the medium-size DurAVR results from the Anteris EMBARK study at TCT 2026 in San Diego on November 1, 2026, during a session on emerging concepts and innovations in TAVR.

← Back to Startups