Abstract
Background/Need
Endovascular aneurysm repair (EVAR) is widely used for treatment of abdominal aortic aneurysms (AAA), but 1-5% of grafts require explantation due to complications such as endoleak or infection. Current techniques rely on modified non-FDA approved techniques that risk vessel trauma. We have designed and constructed the EVAx device to support the efficient and non-traumatic retrieval of AAA endografts that rely on suprarenal barb fixation.
Methodology and Device Description
We designed a single-use, handheld EVAx device for open endograft removal. It features a cylindrical base, diameter-reducing clamp, and variable constraining arms with tapered tips. Activation collapses the graft and disengages suprarenal barb elements. Prototypes were 3D printed and iteratively refined to facilitate future verification and validation testing.
Preliminary Results
Benchtop testing demonstrated successful engagement of the proximal endograft and suprarenal barbs. Endografts were successfully constrained with adequate reduction of the endograft diameter, disengagement of the barbs, and subsequent retrieval.
Current Status
EVAx is undergoing further design optimization with high-fidelity bench-top models and preclinical animal testing. Future use will be intended for the efficient and non-traumatic extraction of aortic endografts with suprarenal fixation.
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