Anteris Technologies Ltd’s (ASX:AVR) (OTCMKTS:AMEUF) anti-calcification comparison study demonstrates that the company's ADAPT® treated tissue has superior anti-calcification attributes compared with tissues used in competitor valves.
Results at the half-way point of four months showed ADAPT® – used in their game-changing DurAVR™ 3D single-piece aortic valve – had approximately 40% less calcium concentration compared with the Medtronic AOA™ arm – tissue used in commercially available SAVR (surgical aortic valve replacement) and TAVR (transcatheter aortic valve replacement) valves.
The interim results correlated with existing clinical data and those of the prior head-to-head study with a similar protocol which produced significant differentials between ADAPT® tissue and Edwards Life Sciences’ Thermafix tissue at the eight to 12-month mark.
Highly positive results
Anteris chief executive officer Wayne Paterson said: “The results were highly positive for ADAPT®, indicating our ADAPT® anti-calcification treatment is statistically superior to both of the major competitors.
“Whilst we have long understood the clinical superiority of ADAPT®, it’s critical for the regulatory submission to prove this against market incumbents specifically in the TAVR space.”
Samples implanted
A total of 48 juvenile rats were implanted with four different samples into separate subcutaneous pockets for calcification evaluation of the following tissues:
- ADAPT®-treated bovine pericardium;
- AOA™-treated porcine tissue;
- AOA™-treated bovine tissue; and
- Control (Glutaraldehyde-treated bovine pericardium).
The final results of the eight-month study will be used in the US Food and Drug Administration submissions to demonstrate DurAVR™ superiority compared with currently available valves subject to the final results being consistent with these positive interim results.
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