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. It is shown that by trapping a sub‐millimeter clinical catheter inside the aneurysm sac using a flow diverter stent (FDS), instant hemostasis can be achieved by filling the aneurysm sac using a novel biomaterial, rescuing catastrophic bleeding in large‐animal models. Multiple formulations of a biomaterial comprising gelatin, nanoclay (NC), and iohexol are developed, optimized, and extensively tested in vitro to select the lead candidate for further testing in vivo in murine, 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 outperform control groups, including a subset that receive 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. WNAs are challenging to treat, and when they rupture, they can lead to significant mortality. In this work, it is shown that embolization of the aneurysm sac using a gel embolic agent in combination with a flow diverter stent can safely treat non‐ruptured and ruptured aneurysms in large‐animal models. This combinatorial approach may best treat complex WNAs and save lives.