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Clinical Trial
. 2025 Feb;32(1):57-67.
doi: 10.1177/15266028231165731. Epub 2023 Apr 19.

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

Stefan P M Smorenburg  1   2 , Rutger J Lely  2   3 , Bas-Jeroen van Kelckhoven  4 , Erik G Vermeulen  5 , Kak Khee Yeung  1   2 , Rombout R Kruse  6 , Martin Kraai  7 , Chrit M Stassen  7 , Michael J Jacobs  8   9 , Arjan W J Hoksbergen  1   2
Affiliations
Clinical Trial

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

Stefan P M Smorenburg et al. J Endovasc Ther. 2025 Feb.

Abstract

Purpose: The aim of this study was to assess the initial experience, technical success, and clinical benefit of AneuFix (TripleMed, Geleen, the Netherlands), a novel biocompatible and non-inflammatory elastomer that is directly injected into the aneurysm sac by a translumbar puncture in patients with a type II endoleak and a growing aneurysm.

Materials and methods: A multicenter, prospective, pivotal study was conducted (ClinicalTrials.gov:NCT02487290). Patients with a type II endoleak and aneurysm growth (>5 mm) were included. Patients with a patent inferior mesenteric artery connected to the endoleak were excluded for initial safety reasons. The endoleak cavity was translumbar punctured with cone-beam computed tomography (CT) and software guidance. Angiography of the endoleak was performed, all lumbar arteries connected to the endoleak were visualized, and AneuFix elastomer was injected into the endoleak cavity and short segment of the lumbar arteries. The primary endpoint was technical success, defined as successful filling of the endoleak cavity with computed tomography angiography (CTA) assessment within 24 hours. Secondary endpoints were clinical success defined as the absence of abdominal aortic aneurysm (AAA) growth at 6 months on CTA, serious adverse events, re-interventions, and neurological abnormalities. Computed tomography angiography follow-up was performed at 1 day and at 3, 6, and 12 months. This analysis reports the initial experience of the first 10 patients treated with AneuFix.

Results: Seven men and 3 women with a median age of 78 years (interquartile range (IQR), 74-84) were treated. Median aneurysm growth after endovascular aneurysm repair (EVAR) was 19 mm (IQR, 8-23 mm). Technical success was 100%; it was possible to puncture the endoleak cavity of all treated patients and to inject AneuFix. Clinical success at 6 months was 90%. One patient showed 5 mm growth with persisting endoleak, probably due to insufficient endoleak filling. No serious adverse events related to the procedure or AneuFix material were reported. No neurological disorders were reported.

Conclusion: The first results of type II endoleak treatment with AneuFix injectable elastomer in a small number of patients with a growing aneurysm show that it is technically feasible, safe, and clinically effective at 6 months.

Clinical impact: Effective and durable embolization of type II endoleaks causing abdominal aortic aneurysms (AAA) growth after EVAR is challenging. A novel injectable elastic polymer (elastomer) was developed, specifically designed to treat type II endoleaks (AneuFix, TripleMed, Geleen, the Netherlands). Embolization of the type II endoleak was performed by translumbar puncture. The viscosity changes from paste-like during injection, into an elastic implant after curing. The initial experience of this multicentre prospective pivotal trial demonstrated that the procedure is feasible and safe with a technical success of 100%. Absence of AAA growth was observed in 9 out of 10 treated patients at 6 months.

Keywords: abdominal aortic aneurysm; abdominal aortic aneurysm, AAA growth; elastomer; embolization; endovascular aneurysm repair; polymer; translumbar; type II endoleak.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.J.J. is in the advisory board of TripleMed B.V. and patent holder of the elastomer formula of the AneuFix material.

Figures

Figure 1.
Figure 1.
Dispenser for injection (A) and syringe with AneuFix 2-component polymer (B).
Figure 2.
Figure 2.
The needle puncture route (A) on preoperative computed tomography angiography (CTA), with needle guidance software based on intraoperative cone-beam computed tomography (CT) (B), and return of blood from the needle, indicating puncture of endoleak cavity (C).
Figure 3.
Figure 3.
Angiogram of the endoleak cavity (A, C, E) with connecting lumbar arteries (arrow) and fluoroscopic result after AneuFix injection (B, D, F) with filling of small section of a feeding lumbar artery (arrow). Directions of view are anterior-posterior (A, B) and lateral (C–F).
Figure 4.
Figure 4.
Preoperative computed tomography angiography (CTA) with type II endoleak (A,B) and connecting lumbar arteries (blue arrow) with endoleak cavity (orange arrow) and postoperative CTA with AneuFix treatment (C,D) and treated lumbar arteries (blue arrow) with treated endoleak cavity (orange arrow).
Figure A1.
Figure A1.
Flowchart of study design.
See this image and copyright information in PMC

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