One-Year Patient Outcomes Presented for Anteris DurAVR THV

March 31, 2025—Anteris Technologies Global Corp. recently announced 1-year results for patients treated with the company’s balloon-expandable DurAVR transcatheter heart valve (THV) system.

According to Anteris, the DurAVR device continues to demonstrate a consistent safety and efficacy profile, with high implant success across the clinical program.

Rishi Puri, MD, presented the 1-year data at a late-breaking clinical trial session at Sydney Valves 2025 held March 20-22 in Sydney, Australia.

The company stated that 65 patients have completed the primary endpoint measure at 30 days, previously reported as rolling cohorts at multiple medical conferences through 2023 to 2024.

As outlined in the Anteris press release, the 1-year results for the DurAVR THV included the following:

• A favorable hemodynamic profile was sustained, with an effective orifice area of 2.1 ± 0.2 cm², a mean pressure gradient of 8.6 ± 2.6 mm Hg, and a Doppler velocity index of 0.58.
• Positive clinical safety outcomes with no valve- or cardiovascular-related mortality and no prosthesis-patient mismatch (PPM) were reported in these small-annuli patients (aortic annulus area, 395.80 ± 37.26 mm²). Current commercial devices have demonstrated rates of 11.2% to 35.3% PPM, a predictor of valve failure and disease progression, noted the company.

The 1-year data will be included in the planned submission to the FDA seeking approval of an investigational device exemption to conduct the DurAVR THV randomized, global pivotal study, advised Anteris.