Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has successfully implanted its synthetic heart valves in five transcatheter aortic valve replacement patients.
The operations occurred in November, at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia, in what the company describes as a first-in-human (FIH) study to assess the DurAVR™ THV system for treating severe aortic stenosis.
The transcatheter aortic valve replacement procedures for all five patients were successful and proceeded without any complications.
Anteris’s chief medical officer Dr Chris Meduri and Medical Advisory Board members, Dr Paul Sorajja and Dr Vinayak Bapat, conducted the procedures while Dr Nadira Hamid, of Columbia University, New York, performed the echocardiograms. Medical support was provided by the local team under the supervision of Dr Tamaz Shaburishvili.
“We are grateful for the patients who consented to being a part of the study as well as the physicians who performed the implants," AVR CEO Wayne Paterson said.
"The Anteris team has done a phenomenal job to date to move this technology into the clinical setting in such a short timeframe.”
Success across key indicators
The study was designed to assess a number of performance endpoints, including the correct positioning of the valve and the haemodynamic performance of the valve.
Safety endpoints, to be checked at 30 days and one year post-operatively, include all-cause mortality, heart attack, stroke or disability and life-threatening bleeding.
Other endpoints of the trial include ease of use of the valve and adverse events according to VARC-3 criteria.
More patients
Following the success of these first human implants, an additional five patients are planned for treatment in the first quarter of 2022.
This will successfully conclude the study.