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Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma
Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the TRUFILL 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.
About this update from Johnson & Johnson
[{"type":"text","content":"- TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery.- Approval builds on a trusted solution in neurovascular embolization for over 25 years.","length":285,"tagName":"p"},{"type":"text","content":"IRVINE, Calif., Dec. 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the TRUFILL 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.","length":459,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Johnson & Johnson MedTech)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Johnson & Johnson MedTech)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":114,"url":"https://media.zenfs.com/en/prnewswire.com/0b575940e521c4a34c26e08381eb674d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/eD9wMiwpiGujk_xLscPewA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIwMTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/0b575940e521c4a34c26e08381eb674d","width":400,"height":114}},"href":"https://mma.prnewswire.com/media/2554601/Johnson_Johnson_MedTech_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"cSDH is often caused by minor head trauma that leads to bleeding between the dura and arachnoid membranes, particularly among older adults and those on anticoagulation therapy. While surgical intervention is the traditional standard of care, recurrence rate estimates range between 10% to 20%. Embolization of the MMA offers a minimally invasive endovascular approach by targeting smaller brain vessels thought to contribute to hematoma persistence and regrowth.1","length":463,"tagName":"p"},{"type":"text","content":"The approval is supported by findings from the MEMBRANE randomized controlled trial, which evaluated the safety and effectiveness of MMA embolization in patients with cSDH2. The results of the MEMBRANE study demonstrated that TRUFILL n-BCA is superior in effectiveness compared to Standard of Care (SOC) for embolizat...