Treatment of Ruptured Wide-Necked Aneurysms Using A Microcatheter Injectable Biomaterial.

Ruptured wide-neck aneurysms (WNAs), especially in a setting of coagulopathy, are associated with significant morbidity and mortality. We show that by trapping a sub-millimeter clinical catheter inside the aneurysm sac using a flow diverter stent (FDS), we can achieve instant hemostasis by filling the aneurysm sac using a novel biomaterial rescuing catastrophic bleeding in large animal models. Here, multiple formulations of a biomaterial comprising gelatin, nanoclay, and iohexol were developed, optimized, and extensively tested in vitro to select the lead candidate for further testing in vivo in rat, porcine and canine models of WNAs, including in a subset with aneurysm rupture. The catheter-injectable and x-ray visible versions of the gel embolic agent (GEA) with the optimized mechanical properties outperformed control groups, including a subset that received a clinically used liquid embolic (Onyx, Medtronic), with and without aneurysm rupture. A combinatorial approach to ruptured WNAs with GEA and FDS may change the standard of medical practice and save lives. This article is protected by copyright. All rights reserved.