Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2...

Area of Science:

• Vascular Surgery
• Interventional Radiology
• Biomaterials Engineering

Background:

• Type II endoleaks after endovascular aneurysm repair (EVAR) can lead to abdominal aortic aneurysm (AAA) growth.
• Effective and durable embolization of these endoleaks remains a clinical challenge.

Purpose of the Study:

• To assess the initial experience, technical success, and clinical benefit of AneuFix, an injectable elastomer for treating type II endoleaks.
• To evaluate AneuFix in patients with growing aneurysms following EVAR.

Main Methods:

• A multicenter, prospective study involving 10 patients with type II endoleaks and AAA growth.
• Translumbar puncture and cone-beam CT guidance for AneuFix injection into the endoleak sac and lumbar arteries.
• Assessment of technical success (filling) and clinical success (absence of AAA growth) at 6 months via CT angiography.

Main Results:

• 100% technical success was achieved, with successful AneuFix injection in all patients.
• 90% clinical success at 6 months, with 9 out of 10 patients showing no AAA growth.
• No serious adverse events or neurological abnormalities related to the AneuFix procedure were reported.

Conclusions:

• AneuFix is a technically feasible, safe, and clinically effective option for treating type II endoleaks causing AAA growth.
• The injectable elastomer demonstrates promising results for managing post-EVAR endoleaks.
• Further investigation in larger cohorts may solidify its role in vascular interventions.