FDA Approval Expands Middle Meningeal Artery Embolization Options for Chronic Subdural Hematoma
The Food and Drug Administration (FDA) has approved an expanded indication for the TRUFILL n-BCA Liquid Embolic System (Johnson & Johnson, Irvine, CA) to include embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery. The decision adds an endovascular option to the management of cSDH, a condition with recurrence rates of approximately 10% to 20% following conventional surgical evacuation, particularly among older adults and patients receiving anticoagulation therapy.
TRUFILL n-BCA is a liquid embolic agent with applications in neurovascular procedures, including treatment of arteriovenous malformations. The newly approved indication reflects growing clinical interest in MMA embolization, which targets dural arterial supply believed to contribute to hematoma persistence and recurrence. The expanded label allows use of TRUFILL n-BCA specifically for MMA embolization in patients with symptomatic subacute or chronic subdural hematoma when used alongside surgical management.
The FDA approval was based on data from the MEMBRANE study (NCT04816591). The randomized controlled study compared the safety and effectiveness of MMA embolization using TRUFILL n-BCA vs standard of care approaches in the treatment of people with symptomatic cSDH. According to a statement from Johnson & Johnson, study results demonstrated both the safety and superior effectiveness of TRUFILL n-BCA relative to standard of care.
Source: Johnson & Johnson MedTech. Johnson & Johnson receives FDA approval for TRUFILL n-BCA Liquid Embolic System for the treatment of symptomatic chronic subdural hematoma. PR Newswire. Published 18 December, 2025. Accessed 22 December, 2025. https://www.prnewswire.com/news-releases/johnson--johnson-receives-fda-approval-for-trufill-nbca-liquid-embolic-system-for-the-treatment-of-symptomatic-chronic-subdural-hematoma-302645188.html?tc=eml_cleartime