R&D
XS Innovations is currently further developing and testing the prototype. So far, the device prototype has shown to be effective in four studies. Not only has it proven its functionality in initial animal testing but is also undergoing rigorous biological impact assessments.
Prototype development
In the prototype development several studies have already been performed, e.g., a cadaveric arm study and two goat studies.
Preclinical
The preclinical phase entails biological functionality, placement & immobility and longer term biocompatibility testing.
Clinical
In the clinical phase XS Innovations will test and evaluate the effects of the Dynamic AVF on humans.
Prototype development
Cadaveric arm study
December 2021
XSI performed a study on human cadaveric arm to verify the implantation method and dimensions of the device ex vivo. The mock-up fits easily in cadaveric human arm (BMI and height considered average), could be placed and arm could be closed. Moving arm did not result in rupture of anastomotic sutures.
In vitro mechanical characterisation
January 2022
In January 2022, a mechanical characterization in a benchtop setting was performed. Technical requirements before implantation into animal model, such as non-invasive control of pressurized graft up to skin with a thickness of 5 mm, was determined to be possible.
Goat study 1
February 2022
The first goat study proved the possibility of implantation, non-invasively controlled flow in an acute setting and the feasibility of an actuation method.
Goat study 2
December 2022
The second goat study focused on functionality testing. Closing the AVF normalizes arterial flow and the device appears to be functional after explantation.