First in Human Aortic Aneurysm Sac Filling with AneuFix Injectable Polymer during Endovascular Aneurysm Repair

Area of Science:

• Vascular Surgery
• Medical Devices
• Biomaterials

Background:

• Type II endoleak (T2EL) following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) increases risks of aneurysm enlargement and rupture.
• Aneurysm sac filling during EVAR is a potential strategy to prevent T2EL.
• High-risk AAA patients require innovative solutions to mitigate T2EL complications.

Purpose of the Study:

• To evaluate the feasibility and safety of AneuFix, an injectable polymer, for aneurysm sac filling during EVAR.
• To assess AneuFix's potential in preventing T2EL in high-risk AAA patients.
• To determine the impact of AneuFix on AAA diameter and volume post-EVAR.

Main Methods:

• A first-in-human, single-arm, feasibility trial involving five high-risk AAA patients.
• AneuFix polymer was injected into the aneurysm sac around the stent graft during EVAR using a filling sheath.
• Primary outcomes included technical success and safety (serious adverse events); secondary outcomes assessed AAA dimensions, T2EL, and re-intervention rates at 6 and 12 months.

Main Results:

• 100% technical success was achieved with complete aortic lumen filling.
• No device-related serious adverse events occurred; one procedure-related event resolved without sequelae.
• Median AAA diameter decreased from 62 mm post-procedure to 56 mm at 12 months, with significant volume reduction. No T2ELs or re-interventions were observed.

Conclusions:

• AneuFix sac filling during EVAR is technically feasible and safe in this initial patient cohort.
• The procedure demonstrated promising results with aneurysm sac shrinkage observed at 12 months.
• A multicenter trial is underway to further confirm the feasibility and safety of AneuFix for T2EL prevention.