First-in-human experience with neocasttm a solvent-free, non-adhesive, and distal penetrating embolic material in pre-surgical embolization of hypervascular tumors.

Abstract

Introduction NeoCastTM is a next-generation (solvent-free and non-adhesive) embolic material that is designed specifically for procedures where deep distal penetration is desired. Aim of Study Safety and feasibility assessment of NeoCast in pre-surgical middle meningeal artery embolization of hypervascular brain tumors. Methods The EMBO-01 study was an open-label, multicenter, prospective first-in-human clinical trial. The primary safety endpoint was freedom from device related disabling stroke or neurological death within 30 days of the embolization procedure. The primary feasibility endpoint was defined as the successful injection of NeoCast into targeted vessel(s) supplying the tumor, resulting in complete occlusion at or distal to the point of embolysate injection. Results Five subjects were enrolled with an average tumor size of 5.0 +/- 1.2 cm. All subjects were successfully embolized with NeoCast achieving complete occlusion of targeted vessels. There were no adverse events or device deficiencies during the embolization procedure. Post-procedure CT showed exceptional penetration into the tumor vasculature with minimal artifact. An independent core lab determined there was no non-target embolization and measured the average percent tumor devascularization as 88 +/- 7%. No significant differences were noted between Modified Rankin scores pre-embolization and pre-surgery. Tumor resection was successful and considered complete (Simpson Grade 1 or 2) with minimal estimated blood loss for all subjects. All subjects successfully met both the primary feasibility and safety endpoints. Conclusion Our first-in-human clinical experience has demonstrated the potential of NeoCast, a next-generation embolic material, to provide safe and effective embolization where deep distal penetration is desired.