Johnson & Johnson MedTech announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded indication for its TRUFILL n-BCA Liquid Embolic System. The system is now approved for the embolization of the middle meningeal artery (MMA) to treat symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgical intervention.
This regulatory milestone marks a significant shift in the management of cSDH, a condition that has long challenged neurosurgeons due to high recurrence rates following traditional surgery.
Addressing an Unmet Need in Neurovascular Care
Chronic Subdural Hematoma (cSDH) typically occurs when minor head trauma causes blood to leak into the space between the brain’s surface and its outermost covering (the dura). This condition is particularly prevalent among the elderly and patients on blood-thinning medications.
While surgical drainage is the standard treatment, it often fails to address the underlying cause of the bleeding. Estimates suggest that between 10% and 20% of patients experience a recurrence of the hematoma after surgery, often requiring multiple procedures.
By targeting the middle meningeal artery, the primary blood supply to the membranes where these hematomas form, the TRUFILL n-BCA system provides a minimally invasive way to “shut off” the vessels contributing to the persistent bleeding and regrowth.
Clinical Evidence: The MEMBRANE Trial
The FDA approval was heavily supported by data from the MEMBRANE randomized controlled trial. The study compared the use of MMA embolization using TRUFILL n-BCA against the standard of care (SOC).
Key findings from the trial included:
- Superior Effectiveness: The TRUFILL n-BCA system was found to be significantly more effective than standard treatments in reducing the re-accumulation of hematomas.
- Safety Profile: The study demonstrated that the system is safe for use in cSDH patients, with an Odds Ratio (OR) of 0.475 for residual accumulation or re-operation at six months—indicating a nearly 50% improvement in outcomes for the surgical cohort.
- Reduced Re-operation: Patients treated with the embolic system were less likely to require secondary surgical procedures compared to those receiving SOC alone.
