Advancing Neurosurgical Practices: FDA Approvals and Contemporary Trial Insights
The FDA has expanded the indication for TRUFILL n-BCA to permit middle meningeal artery embolization in symptomatic subacute and chronic subdural hematoma, citing randomized MEMBRANE trial evidence and broadening adjunctive management options. Clinically, this change affects neurosurgeons and neurointerventional teams who manage patients at elevated risk for recurrence after evacuation.
Surgical burr‑hole evacuation with drain placement remains the standard for symptomatic cSDH, with recurrence and reoperation rates commonly reported at roughly 10%–20%. Middle meningeal artery embolization targets the dural arterial supply that sustains the neomembrane and ongoing bleeding; used with evacuation, it reduces the biological drivers of recurrence and therefore offers a validated adjunct for selected patients.
The MEMBRANE trial randomized patients to embolization with TRUFILL n‑BCA plus standard care versus standard care alone, using a primary endpoint of hematoma recurrence or reoperation.
Safety analyses did not identify excess device‑related serious adverse events, and overall adverse event rates were comparable between arms. Secondary and exploratory outcomes—including functional status, length of stay, and imaging-confirmed hematoma resolution—were reported but merit cautious interpretation given the trial’s scope and follow‑up.
Taken together, the available data support a favorable benefit–risk profile that justifies selective adoption while centers formalize patient selection and procedural pathways.
Key Takeaways:
- FDA expanded TRUFILL n‑BCA’s indication to allow MMA embolization as an adjunct for symptomatic subacute and chronic subdural hematoma.
- Randomized MEMBRANE trial evidence demonstrated reduced recurrence or reoperation with embolization plus standard care versus standard care alone.
- Safety signals were acceptable, supporting selective clinical adoption while institutions define pathways, training, and outcome monitoring.