JnJ Medtech bags USFDA nod for TRUFILL n-BCA Liquid Embolic System for Symptomatic Chronic Subdural Hematoma
Irvine: Johnson & Johnson MedTech has 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.
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.
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. The results of the MEMBRANE study demonstrated that TRUFILL n-BCA is superior in effectiveness compared to Standard of Care (SOC) for embolization in the MMA for the treatment of symptomatic cSDH, and importantly, TRUFILL n-BCA was demonstrated to be safe for treating cSDH.
“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,” said Christian Cuzick, President, Worldwide Neurovascular, Johnson & Johnson MedTech.
“There is an unmet need for new treatment options for chronic subdural hematoma, particularly for patients at risk of recurrence or complications from surgery,” said Dr. Chris Kellnerii, Director of Cerebrovascular & Intercerebral Hemorrhage programs, Mount Sinai, and investigator in the MEMBRANE trial. “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.”
