Anteris Technologies Pty Ltd ( ASX:AVR , NASDAQ:AVR ) has reported encouraging 30-day clinical and haemodynamic results for the medium-size DurAVR transcatheter heart valve (THV), including low pressure gradients, large valve openings and no valve-related deaths.
Results from 22 patients with severe aortic stenosis and medium-sized aortic annuli in the EMBARK Study showed a mean pressure gradient of 6.17 mmHg at 30 days, compared with 45.5 mmHg before treatment.
Effective orifice area, a measure of the opening available for blood flow through the valve, increased to 2.64 square centimetres from 0.8 square centimetres at baseline.
No patients experienced moderate or severe paravalvular leakage, while there were no cases of moderate or severe prosthesis-patient mismatch and no valve-related mortality.
The results were presented at the Transcatheter Cardiovascular Therapeutics Conference in San Diego.
Results support DurAVR design
Anteris chief medical officer Dr Chris Meduri said the results demonstrated the haemodynamic profile the company designed DurAVR to achieve.
"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," Meduri said.
"That matters because prosthesis-patient mismatch is not just a small-annulus problem."
Prosthesis-patient mismatch occurs when an implanted valve opening is too small relative to a patient's blood-flow requirements, resulting in higher-than-expected pressure gradients.
PARADIGM trial underway
DurAVR is now being evaluated in Anteris' global PARADIGM pivotal trial, which is actively enrolling patients and will include use of the medium-size valve.
The prospective randomised controlled study is expected to enrol about 1,000 patients, comparing DurAVR directly with commercially available transcatheter aortic valve replacement systems.
Its primary endpoint will assess whether DurAVR is non-inferior to existing valves based on a combination of all-cause mortality, stroke and cardiovascular hospitalisation one year after treatment.
Read more about Anteris here .
