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

bridge_anxiety · 2025-12-26T05:12:09+00:00

Johnson & Johnson's MedTech division received FDA approval for the TRUFILL n-BCA Liquid Embolic System for embolization of the middle meningeal artery, aiding treatment of chronic subdural hematoma. This expansion is supported by evidence from the MEMBRANE study, highlighting its effectiveness and safety.

bridge_anxiety

2025-12-26 05:12:09

Abstract generation in progress

Johnson & Johnson’s MedTech division has secured a significant regulatory milestone with the FDA’s green light for a broader clinical application of its TRUFILL n-BCA Liquid Embolic System. The approval now permits the device to be used for minimally invasive embolization of the middle meningeal artery as a surgical adjunct in managing patients suffering from symptomatic subacute and chronic subdural hematoma (cSDH).

The expansion is grounded in robust clinical evidence from the MEMBRANE study, which demonstrated the therapeutic advantages of middle meningeal artery embolization in the cSDH patient population. Comparative analysis showed that TRUFILL n-BCA outperformed conventional treatment approaches in achieving effective MMA embolization outcomes while maintaining a strong safety profile throughout the trial.

This regulatory milestone represents an important development in neurosurgical intervention, offering clinicians an additional tool for managing one of the most common intracranial conditions in elderly patients. The approval underscores J&J MedTech’s commitment to advancing minimally invasive solutions in the neurointerventional space.

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