Abstract 043: Endovascular Drainage of Subdural Hematomas with EMBODRAIN System

Introduction/Purpose Subdural hematomas (SDHs) are among the most common neurosurgical conditions, particularly affecting the elderly. Standard treatment paradigms include surgical evacuation and, more recently, middle meningeal artery embolization (MMAe) to prevent recurrence. These interventions are typically performed as separate procedures by different teams, often under general anesthesia. This fragmented approach introduces inefficiencies, procedural risks, and access barriers—especially for frail or medically complex patients.To address these limitations, we developed the first endovascular system enabling single‐session , fully transvascular treatment of non‐acute SDH. The procedure integrates MMA embolization and catheter‐based subdural evacuation through the same arterial access, obviating the need for craniotomy. A proprietary system of devices allow controlled perforation of the arterial wall and dura, enabling catheter navigation into the subdural space for drainage. Materials and Methods In a prospective, single‐arm, first‐in‐human study (EMBODRAIN), we enrolled 16 consecutive patients with symptomatic non‐acute SDH. Two patients were excluded due to anatomical reasons (diminutive MMA in one case, and MMA emerging from ophthalmic artery in one case). Patients were followed clinically and radiographically for 30 days. Results All fourteen treated patients (mean age 73.6 years; 80% male) underwent successful MMA embolization and transvascular subdural drainage without intraoperative complications or need for surgical backup. SDH volume was reduced by >65% in average. Midline shift improved from 9.7 ± 3.8 mm to 4.2 ± 2.1 mm. Functional status also improved rapidly: Modified Rankin Scale (mRS) scores decreased from a mean of 2.7 to 1.3, and Markwalder Grading Scale scores from 1.9 to 0.7 within 72 hours. There were no hemorrhagic complications, neurologic deteriorations, or radiographic reaccumulations. No patients required ICU admission or anticoagulation reversal. Conclusions This first‐in‐human experience establishes the safety, technical feasibility, and early clinical effectiveness of fully endovascular treatment of non‐acute SDH. The approach provides a streamlined, minimally invasive solution that integrates embolization and hematoma evacuation into a single transvascular session. Beyond SDH, this technology lays the foundation for transvascular neurosurgery —a new paradigm that utilizes endovascular access to treat traditionally non‐vascular intracranial pathologies. Its potential to transform intracranial therapeutics, improve access, and reduce treatment morbidity is significant and warrants further clinical investigation. image FundingSupportResearch : National Institutes of Health (NIH)