NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson MedTech, the medical technology arm of Johnson & Johnson (J&J) on Thursday said the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its TRUFILL n-BCA Liquid Embolic System. The device is now cleared for embolization of the middle meningeal artery (MMA) as an adjunct to surgery in the treatment of symptomatic subacute and chronic subdural hematoma (cSDH).
The approval is supported by the MEMBRANE study, which evaluated the safety and effectiveness of MMA embolization in patients with cSDH. The study found that TRUFILL n-BCA was more effective than standard of care for MMA embolization in treating symptomatic cSDH, while demonstrating a favorable safety profile.
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