A first-in-human, prospective feasibility trial of a next-generation, shear-responsive, liquid embolic biomaterial, NeoCast featuring Arsenal Medical
Abstract
Background
NeoCastTM is a solvent-free, non-adhesive biomaterial engineered to achieve microvascular occlusion. EMBO-01 is the first-in-human trial of NeoCast for the pre-surgical embolization of hypervascular brain tumors supplied by the middle meningeal artery (MMA).
Methods
EMBO-01 was an open-label, multicenter, prospective, externally monitored, and core lab adjudicated clinical trial. The primary safety endpoint was freedom from device-related disabling stroke or neurological death within 30 days of embolization. The primary effectiveness endpoint was successful injection of NeoCast into targeted vessel(s), resulting in complete occlusion at or distal to the point of embolysate injection. Additional assessments included occurrence of microcatheter adhesion and non-target embolization, percent tumor devascularization, extent of resection, estimated intraoperative blood loss, and surgical time.
