Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF)’s 30-day follow-up on the second cohort of eight patients in its DurAVR™ THV study, testing aortic valve replacement technology, has shown clinically significant improvements.
All 13 patients in the first-in-human study conducted at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia, continue to show marked improvements in their clinical status compared with pre-treatment levels.
Improved blood flow
Specifically, there was an average 81% decline in mean pressure gradient (range of -89% to -74%) with an average 300% increase in effective orifice area (EOA) (range of 217% to 582%), denoting a marked improved in the valve’s surface area and, therefore, improved blood flow.
The company continues to observe "remarkable" haemodynamics, including best-in-class laminar flow and improved (normalised) pressures under high cardiac output conditions.
The ComASUR™ delivery system performed as expected, allowing accurate valve placement.
Importantly, the data showed excellent improvement in quality-of-life markers, including the six-minute walk test.
“Complex anatomy”
“We continue to be excited about the superior haemodynamic performance of the DurAVR™ system despite small annuli and complex anatomy,” said Anteris chief medical officer Dr Chris Meduri.
“Its remarkable flow characteristics are as close to a normal human aortic valve as we have seen, a testament to the unique 3D tissue design.”
“The data so far is extremely encouraging and fulfilling the hypothesis that DurAVR™ works better and lasts longer,” CEO Wayne Paterson added.
“As we move into the second half, we will continue enrolling patients into our studies (Europe and FDA EFS) and gathering data for presentation at the major conferences as well as regulatory filings throughout the rest of the year.
“We will continue generating non-patient data as well with leading research institutions that demonstrate DurAVR’s superior flow characteristics compared with competitor valves as well as other relevant data.”
More results will be reported at the 12-month mark.