FDA Expands Indication for n‐Butyl Cyanoacrylate in Chronic Subdural Hematoma

The FDA has approved the expanded indication for Johnson & Johnson's n‐butyl cyanoacrylate (Trufill) liquid embolic system as an adjunct to surgery for middle meningeal artery (MMA) embolization in patients with symptomatic subacute and chronic subdural hematoma (cSDH). The company noted that therapy has been used in neurovascular embolization for more than 25 years and has supported the treatment of arteriovenous malformations since its initial FDA approval in 2000.¹

The approval was supported by findings from the MEMBRANE randomized controlled trial (NCT04816591), which evaluated the safety and efficacy of MMA embolization in approximately 376 adult patients with cSDH. In trial, researchers observed a statistically significant treatment benefit with n-butyl cyanoacrylate compared with standard of care in patients treated with or without surgery (P = .044).² Overall, the study demonstrated superior efficacy of n-butyl cyanoacrylate and supported its safety in the treatment of cSDH.

"There is an unmet need for new treatment options for chronic subdural hematoma, particularly for patients at risk of recurrence or complications from surgery," investigator Chris Kellner, MD, the director of Cerebrovascular & Intercerebral Hemorrhage programs at Mount Sinai, said in a statement.¹ "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."

MEMBRANE was a prospective, multicenter, open‐label, randomized‐controlled trial that enrolled participants in about 35 sites in the United States and China. After demonstrating cSDH stability, participants were randomized in the surgical or nonsurgical cohort to receive standard‐of‐care with or without TRUFILL n‐butyl cyanoacrylate MMA embolization.³ The primary trial endpoint was cSDH recurrence in 3 months of follow-up after surgery, while secondary end points comprised of neurological deficits assessed by the modified Rankin Scale and recurrence- or intervention-associated complications during 3 months of follow-up.⁴

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Additional findings from the study revealed that endovascular MMA embolization was noninferior to standard of care alone for achieving a good functional outcome. Researchers also reported that secondary efficacy, safety, and health economic outcomes generally favored embolization compared with standard of care alone. In terms of safety, adverse events were reported in 71.8% of patients in the embolization group and 65.3% of those receiving standard of care.

Prior studies have shown that cSDH commonly results from minor head trauma, leading to bleeding between the dura and arachnoid membranes, particularly in older adults and individuals receiving anticoagulation therapy. Although surgical intervention remains the conventional standard of care, reported recurrence rates have ranged from 10% to 20%.⁴ Thus, MMA embolization provides a minimally invasive endovascular option, targeting smaller vessels believed to contribute to hematoma persistence and recurrence.

"This approval reinforces the enduring value of TRUFILL n-BCA and our commitment to delivering innovative technologies that improve outcomes for patients and address complex neurovascular conditions," Christian Cuzick, president of Worldwide Neurovascular at Johnson & Johnson MedTech, said in a statement.¹

REFERENCES
1. Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma. News release. Johnson & Johnson. December 18, 2025. Accessed December 18, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-trufill-n-bca-liquid-embolic-system-for-the-treatment-of-symptomatic-chronic-subdural-hematoma
2. Kellner CP, Rai AT, Shoirah H, et al. Middle meningeal artery embolisation for treatment of chronic subdural hematoma with TRUFILL n-butyl cyanoacrylate: MEMBRANE trial primary results. J Neurointerv Surg. 2025;17(suppl 1):A57-A58.
3. Hoenning A, Lemcke J, Rot S, Stengel D, Hoppe B, Zappel K, Schuss P, Mutze S, Goelz L. Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial. Trials. 2022 Aug 22;23(1):703. doi: 10.1186/s13063-022-06506-3. PMID: 35996195; PMCID: PMC9396835.
4. Kellner C, Almufti F, Gupta R, Jankowitz B, Starke R, Rai A. Middle meningeal artery embolization with n-butyl cyanoacrylate for the treatment of subdural hematomas: the MEMBRANE study design. Stroke Vasc Interv Neurol. 2025;5. doi:10.1161/SVIN.125.001828
5. Nouri A, Gondar R, Schaller K, Meling T. Chronic Subdural Hematoma (cSDH): A review of the current state of the art. Brain Spine. 2021;1:100300. Published 2021 Nov 2. doi:10.1016/j.bas.2021.100300