- FDA approves TRUFILL n-BCA for MMA embolization in chronic subdural hematoma.
- cSDH often results from minor head trauma, especially in older adults.
- MEMBRANE trial shows TRUFILL n-BCA is more effective than standard care.
- TRUFILL n-BCA has been used for neurovascular embolization since 2000.
FDA Approval
The FDA has approved an expanded indication for Johnson & Johnson's TRUFILL n-BCA Liquid Embolic System. This approval allows its use for embolization of the middle meningeal artery (MMA) in treating symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery.
Condition Overview
Chronic subdural hematoma is often caused by minor head trauma, leading to bleeding between the dura and arachnoid membranes. It is particularly prevalent among older adults and those on anticoagulation therapy. Traditional surgical intervention has a recurrence rate of 10% to 20%.
Clinical Trial Results
The approval is based on the MEMBRANE randomized controlled trial, which assessed the safety and effectiveness of MMA embolization in cSDH patients. The study demonstrated that TRUFILL n-BCA is more effective than the standard of care for embolization in the MMA and is safe for treating cSDH.
Expert Insights
Dr. Chris Kellner, Director of Cerebrovascular & Intercerebral Hemorrhage programs at Mount Sinai and an investigator in the MEMBRANE trial, highlighted the unmet need for new treatment options for cSDH, especially for patients at risk of recurrence or surgical complications. The study supports the potential of MMA embolization to improve patient outcomes.
Product Background
TRUFILL n-BCA has been a trusted solution in neurovascular embolization for over 25 years, initially approved by the FDA in 2000 for treating arteriovenous malformations (AVMs). This expanded indication extends its established performance to cSDH, where traditional surgical methods may not always be suitable or effective for long-term control.
