The U.S. Food and Drug Administration approved the TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery in patients with symptomatic chronic subdural hematoma (cSDH) on December 18 2025. The approval expands the system’s use beyond neurovascular embolization and provides a minimally invasive endovascular option that can be used as an adjunct to surgical evacuation, a treatment that traditionally carries a 10‑20% recurrence rate.
The decision was driven by the MEMBRANE randomized controlled trial, which enrolled 376 adults across 35 sites in the United States and China. The study demonstrated that MMA embolization with TRUFILL was superior in effectiveness and safety compared with standard of care, reducing the likelihood of hematoma recurrence and the need for repeat surgery. The trial’s findings were pivotal in convincing the FDA that the expanded indication offers a meaningful clinical benefit.
For Johnson & Johnson MedTech, the approval represents a strategic expansion of its neurovascular portfolio. By adding cSDH to the product’s indications, the company taps a sizable market of older adults and patients on anticoagulation who are at high risk for recurrence. The new indication also positions J&J MedTech as a leader in endovascular solutions for a condition that has long been dominated by surgical approaches.
Christian Cuzick, President of Worldwide Neurovascular, said, “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.” Dr. Chris Kellner, a key investigator in the MEMBRANE trial, added, “MMA embolization with TRUFILL offers a promising alternative for patients at risk of recurrence or surgical complications, and the trial data confirm its safety and effectiveness.”
The approval is expected to broaden the commercial reach of the TRUFILL platform, potentially generating incremental revenue as clinicians adopt the new endovascular approach. It also strengthens J&J MedTech’s competitive position against other neurovascular players by offering a proven, long‑standing product in a new therapeutic area. While the immediate financial impact is modest, the approval lays the groundwork for future growth in a high‑need market segment.
Overall, the FDA’s decision marks a significant milestone for Johnson & Johnson MedTech, expanding the therapeutic scope of a trusted embolic system and providing patients with a less invasive treatment option for chronic subdural hematoma.
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