Anteris Technologies (ASX:AVR) has announced one-year clinical results demonstrating sustained favourable hemodynamics and excellent safety outcomes for its DurAVR Transcatheter Heart Valve (THV) in patients with small aortic annuli, including no valve-related mortality and a very low rate of prosthesis-patient mismatch.
The findings are drawn from patients enrolled in the ongoing EMBARK and US Early Feasibility (EFS) studies, with results showing a mean effective orifice area (EOA) of 2.1 ± 0.2 cm² and mean pressure gradient (MPG) of 8.6 ± 2.6 mmHg at one year. There were no cases of moderate or severe paravalvular leak, and prosthesis-patient mismatch at 30 days was just 1.5 per cent, compared with 11.2 per cent to 35.3 per cent reported for current commercial devices.
“With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiologic flow is so critical. The latest results we are seeing with the balloon-expandable DurAVR valve are impressive, showing restoration of laminar flow, favorable hemodynamics sustained to one year, predictable deployment and a high level of procedural success across a variety of anatomies, which is exactly what we need for this patient population,” said Rishi Puri, Coronary and Structural Interventional Cardiologist at the Cleveland Clinic.
The pooled cohort included 65 patients with small aortic annuli treated with the DurAVR THV, and more than 100 patients have now been implanted globally. These encouraging results will be further evaluated in the company’s newly initiated global pivotal PARADIGM Trial, a randomised controlled trial comparing DurAVR to current commercially available transcatheter aortic valve replacement (TAVR) devices.
Prosthesis-patient mismatch remains a significant issue in TAVR for patients with small aortic annuli and is associated with poorer long-term survival. By significantly reducing mismatch rates, DurAVR may address a persistent clinical challenge for this patient population.
DurAVR THV is the first biomimetic valve designed to mimic the natural structure and performance of a healthy human aortic valve. It is made using Anteris’ patented ADAPT tissue technology, which has been used clinically for more than a decade in over 55,000 patients worldwide.
Headquartered in Brisbane with a significant presence in Minneapolis, Anteris is focused on advancing structural heart therapies for patients with severe aortic stenosis.