Anteris Technologies Ltd (ASX: AVR) has successfully wrapped up its final chronic animal study required for the FDA early feasibility study (EFS) submission on its proposed US TAVR clinical trial.
Formal histopathology results for the three-month study (in six sheep) will be available in approximately four weeks.
Its key objectives were to assess
(1) DurAVR THV hemodynamic performance and
(2) the in vivo response. Preliminary findings showed:
- DurAVR THV had fully functioning leaflets and haemodynamics resulting in zero mortalities within the study; and
- DurAVR valve functioned well for the study’s duration, including on the following criteria:
1. Healing characteristics (e.g., pannus formation, tissue overgrowth);
2. Effect of post implantation changes in shape and structural components (e.g., the presence of device angulation, bends, kinks) on haemodynamic performance;
3. Haemolysis;
4. Thrombus formation;
5. Embolisation of material from the implant site, delivery device or heart valve substitute, migration or embolization of the heart valve substitute;
6. Biological response (e.g., inflammation, calcification, thrombosis, rejection, other unexpected interactions with tissues);
7. Interaction with surrounding anatomical structures (e.g., leaflets, annulus, subvalvular apparatus); and
8. Structural valve deterioration and/or non-structural valve dysfunction.
The early review of this data is consistent with observations from previous studies. Once the data is formally analysed it will be submitted to the FDA in the final dossier seeking approval to commence the first in human TAVR study.
