Admedus (ASX:AHZ) has announced the approval for first-in-human surgical aortic valve replacement (SAVR) trial of its proprietary ADAPT single-piece 3D aortic valve at the Leuven University Hospitals.
The SAVR market is estimated at $US3 billion by 2023 with more than 250,000 procedures performed in Europe and North America in 2018.
Fifteen patients will be enrolled in the trial. They will be followed up for 6 months after receiving implantation of the ADAPT single-piece 3D aortic valve. The results from the study are expected to be available in 2021.
The company said its ADAPT bio-scaffold material is notable for its durability and zero calcification virtues evidenced by ten years of published and peer-reviewed data.
According to Admedus CEO Wayne Paterson, “This endorsement of our ADAPT single-piece 3D aortic valve technology is an important next step to our development pathway. The ADAPT single-piece 3D aortic valve has demonstrated excellent haemodynamics, both on the bench and in animal testing, and we expect to see that replicated in humans.
"The ADAPT single-piece 3D aortic valve is uniquely designed as it is essentially the same valve whether it is placed surgically or by TAVR and will thus provide valuable information for the Admedus TAVR program as we move forward. Ultimately, we expect to see better outcomes for patients over the course of this study.”