Johnson & Johnson's TRUFILL n-BCA Receives FDA Clearance for Expanded Subdural Hematoma Treatment Option

Johnson & Johnson MedTech has secured expanded FDA authorization for its TRUFILL n-BCA Liquid Embolic System, marking a significant development in interventional neuroradiology. The device now carries clearance for middle meningeal artery (MMA) embolization as a complementary surgical approach for managing symptomatic subacute and chronic subdural hematoma (cSDH).

Clinical Evidence Drives the Approval

The regulatory decision rests on compelling findings from the MEMBRANE study, which rigorously evaluated the safety and efficacy of MMA embolization in cSDH patients. The research demonstrated that TRUFILL n-BCA outperformed conventional treatment standards when targeting the middle meningeal artery, while maintaining a robust safety profile throughout the study period.

What This Means for Subdural Hematoma Treatments

Chronic and subacute subdural hematomas represent a serious clinical challenge, particularly in elderly populations and patients with coagulopathy. By expanding TRUFILL n-BCA’s approved uses to include MMA embolization, physicians now have an additional therapeutic option that has proven more effective than existing approaches. The technology functions as an adjunctive tool alongside surgical intervention, potentially improving patient outcomes in this challenging patient population.

The FDA’s clearance reflects the growing role of minimally invasive embolization techniques in modern neurosurgery and validates the clinical benefits demonstrated through rigorous comparative analysis. This expanded indication strengthens the treatment arsenal available to neurosurgeons managing subdural hematoma cases.