4.2. DurAVR THV System (Anteris Technologies)DurAVR™
THV is a novel first-in-class biomimetic balloon-expandable valve made to particularly address the challenges related to the THV durability and hemodynamic performance.
DurAVR valve is made from a single piece of tissue which has been designed and molded to mimic the anatomy and performance of a native human aortic valve. This is distinct to all the other commercially available THVs that consist of three separate leaflet tissues sewn onto a valve frame.
Detailed computational fluid modeling comparing the two leaflet designs has revealed that the single-piece leaflet design facilitates optimal laminar flow which results in the uniform distribution of the leaflet stress and hence minimizes leaflet strain and prolongs durability. This results in a more uniform distribution of leaflet stress, facilitating optimal laminar flow and minimizing leaflet strain.
Furthermore, this unique leaflet design offers a larger coaptation area and improved coaptation length, reducing the risk of leaflet pin-rolling. Notably, the DurAVR THV also utilizes the novel ADAPT tissue-engineered anti-calcification technology, employing DNA- and glutaraldehyde-free acellular bovine pericardial leaflet tissue.
This decreases the risk of leaflet calcification and structural valve deterioration (SVD), contributing to the enhanced durability and longevity of the DurAVR THV System.
Additionally, the unique leaflet design allows for a shorter stent height with a spacious open cell geometry, and the ComASUR™ delivery system provides controlled deployment, potentially increasing the likelihood of achieving commissural alignment and facilitating coronary access [15].
In the first-in-human, prospective, single-arm, single-center study designed to assess the safety and feasibility of the DurAVR THV in 20 patients, procedural success was 100%, with no device-related complications.
The DurAVR demonstrated superior hemodynamics, with an effective orifice area (EOA) of 2.36 cm and a mean gradient of 7.8 mm Hg.
These hemodynamic effects were sustained at the 1-year follow-up in the first 12 patients. Furthermore, the CMR testing in the five patients matched to healthy controls showed that DurAVR maintains laminar aortic flow [15].
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