Abstract Body: Introduction: NeoCast is a novel, solvent-free, non-adhesive, shear-thinning, liquid embolic agent designed to reproducibly achieve distal penetration of the microvasculature. In preclinical models NeoCast showed deeper and more consistent distal penetration relative to commercial benchmarks. These properties were confirmed in the EMBO-01 clinical study which demonstrated initial safety, excellent embolic performance, and extensive tumor devascularization in patients with hypervascular extra-axial tumors. Here, we report on the first use of NeoCast for MMA embolization in an initial cohort of patients with chronic subdural hematomas (cSDH) from the EMBO-02 study.
Methods: The EMBO-02 study (ACTRN12624000659505) is an open-label, multicenter, prospective, externally monitored, core lab adjudicated, feasibility clinical trial. The primary safety endpoint is freedom from device related disabling stroke or neurological death within 30 days of embolization. The primary effectiveness endpoint is defined as the successful injection of NeoCast into the middle meningeal artery, resulting in complete occlusion at or distal to the point of injection. Key inclusion criteria include a confirmed diagnosis of a symptomatic cSDH ≥10mm in greatest thickness and a pre-morbid mRS ≤2. Additional assessments include non-target embolization, embolic penetration, an embolic usability assessment, and change in hematoma thickness/volume.
Results: An initial cohort of patients (age range: 55-80 years old) was enrolled in EMBO-02 including one patient presenting with a bilateral hematoma. All target MMA vessels were successfully embolized with NeoCast (volume injected: average 0.22ml, range 0.06-0.43ml) resulting in complete occlusion with no non-target embolization. Injection occurred in both flow-directed (placed proximal to bifurcation) and wedge position (selected distal branch) scenarios. In both scenarios, deep distal penetration was achieved with embolic reaching the falx. The investigator was satisfied to very satisfied with NeoCast’s overall embolization performance as graded on the usability questionnaire. No device-related serious adverse events have been reported to date.