J&J’s TruFill n-BCA Liquid Embolic System Approved to Treat Symptomatic Chronic Subdural Hematoma

December 18, 2025—Johnson & Johnson MedTech announced that the FDA has approved an expanded indication for the company’s TruFill n-Butyl cyanoacrylate (n-BCA) liquid embolic system for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery.

TruFill n-BCA has been used for neurovascular embolization for 25 years including the support of the treatment of patients with arteriovenous malformations since its original FDA approval in 2000, stated Johnson & Johnson.

According to the company, the approval is supported by findings from the MEMBRANE randomized controlled trial, which evaluated the safety and effectiveness of MMA embolization in patients with cSDH.

As noted in the press release, the study demonstrated that TruFill n-BCA is superior in effectiveness compared to the standard of care (SOC) for embolization in the MMA for the treatment of symptomatic cSDH. Additionally, the study showed TruFill n-BCA was safe for treating cSDH.

Christopher Kellner, MD, Director of Cerebrovascular & Intercerebral Hemorrhage programs at Mount Sinai Hospital in New York, New York, is a Principal Investigator of the MEMBRANE trial.

“There is an unmet need for new treatment options for cSDH, particularly for patients at risk of recurrence or complications from surgery,” commented Dr. Kellner in the company’s press release. “The MEMBRANE study demonstrated a positive treatment effect in favor of TruFill over standard of care and reinforces the potential of MMA embolization to improve outcomes for patients with cSDH.”