Aortic Customize: an in vivo feasibility study of a percutaneous technique for the repair of aortic aneurysms using injectable elastomer.

Abstract

OBJECTIVE: This study aimed to test a percutaneous technique for aneurysm-sac filling by means of in situ polymerisation in an in vivo model. DESIGN: Aortic Customize is a new endovascular treatment concept for aortic aneurysms: a non-cross-linked liquid elastomer is injected to fill the aneurysm sac around a balloon-catheter. With this method, a compliant elastomer mould with a patent lumen is created. MATERIAL: The formulation used in the experiments consisted of a two-component addition-cure liquid-silicone formulation, based on vinyl-terminated polydimethylsiloxane (PDMS). METHODS: The concept of aneurysm-sac filling was tested in vivo in porcine experiments (n = 3). RESULTS: In vivo porcine experiments with the sac-filling application showed successful exclusion of the created aneurysms with patent lumens and absence of endoleaks. The aneurysms were excluded successfully in the in vivo model, injecting elastomer through a 7-French catheter, filling up the entire aneurysm sac. CONCLUSIONS: These in vivo experiments demonstrate that the principle of aneurysm-sac filling by means of in situ curing is feasible, excluding the aneurysm and creating a new lumen. Further long-term animal experiments must be done prior to consideration of clinical application.