Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has released 30-day data described as "excellent" from its US early feasibility study (EFS) for the DurAVR™ transcatheter heart valve (THV).
The preliminary results from this study – which includes data from 12 out of the 15 enrolled patients, with three patients awaiting scheduling – demonstrate the impressive performance of the heart valve, which aims to increase the haemodynamics of the heart, along with the effective orifice area (EOA).
Long and short-term benefits
"As a surgeon, we’ve known for decades that the bigger EOA you start with, the longer your valve is going to last, the better you’re going to do both short-term and long-term,” said study chair Dr Michael Reardon.
“So not only will this be a great valve for older people, but for younger people who want to stay active, this is going to be a great valve.”
The patients in the study, with a mean age of 81+/-7 years, and a majority of 67% being female, exhibited a mean annulus diameter of 22.2 +/- 0.8 mm. The key 30-day haemodynamic results are:
- mean Effective Orifice Area (EOA) = 2.13 cm2;
- Mean Pressure Gradient (MPG) = 7.9 mmHg; and
- Doppler Velocity Index (DVI) = 0.62.
There were no instances of paravalvular leaks (PVL) observed at the 30-day follow-up.
Importantly, these 30-day haemodynamic results are consistent with those recorded at patient discharge, indicating no significant changes in EOA or MPG values over this period.
Impeccable safety data
Beyond the exceptional haemodynamic results, the trial boasts impeccable safety data.
There were no reported incidents of stroke, myocardial infarction, life-threatening bleeds, or all-cause mortality within the study group. These favourable patient outcomes will be monitored and reported again at the one-year post-implantation mark.
Anteris chief medical officer Dr Chris Meduri said: "These haemodynamics are unparalleled.
“There’s other exciting things as well. This biomimetic valve not only allows us to have this acute improvement in flow from a classic haemodynamic performance, but also we’ve seen on cardiac MRI, normalisation of laminar flow out of the aorta.
“It’s also likely to have significant implications as we think about the long-term durability of the valve, stress on the leaflets, but also aortopathies, potentially inflammation, other things as well.”
CEO Wayne Paterson said: “This excellent trial data continues to show the benefits of the first-in-class biomimetic valve DurAVR™.
“Coupled with our premium anti-calcification treatment ADAPT® and our Balloon Expandable delivery system (ComASUR™) the company has demonstrated real innovation in valve design leading to these results.
“We continue to build on our data which includes 39 TAVR patients and 50,000 ADAPT® patients across the world. The company is extremely grateful to the physicians and patients who participated in this study.”