Today, Johnson & Johnson (J&J) MedTech announced that the US Food and Drug Administration (FDA) has approved an expanded indication for the Trufill n‑BCA liquid embolic system covering embolisation of the middle meningeal artery (MMA) as an adjunct to surgery in the treatment of symptomatic subacute and chronic subdural haematoma (cSDH).
“There is an unmet need for new treatment options for chronic subdural haematoma, particularly for patients at risk of recurrence or complications from surgery,” said MEMBRANE trial investigator Christopher Kellner (Mount Sinai, New York, USA). “The MEMBRANE study demonstrated a positive treatment effect in favour of Trufill over standard of care and reinforces the potential of MMA embolisation to improve outcomes for patients with cSDH.”
J&J MedTech notes that this approval is supported by findings from the MEMBRANE randomised controlled trial, which evaluated the safety and effectiveness of MMA embolisation in patients with cSDH. The study’s results demonstrated that Trufill n-BCA is superior in effectiveness compared to the standard of care for the treatment of symptomatic cSDH—and MMA embolisation with Trufill n-BCA was demonstrated to be safe in treating these patients too.
“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,” commented Christian Cuzick, president of Worldwide Neurovascular at J&J MedTech.
According to a press release from J&J MedTech, Trufill n-BCA has been a trusted solution in neurovascular embolisation for more than 25 years, supporting the treatment of patients with arteriovenous malformations (AVMs) since its original US FDA approval in 2000. This expanded indication brings Trufill n-BCA’s established performance into the treatment of cSDH—a condition where traditional surgical interventions may not always be suitable or effective for long-term control.
News of J&J’s expanded indication follows Medtronic’s announcement earlier this month of US FDA approval for adjunctive MMA embolisation with its Onyx liquid embolic system in the treatment of cSDH patients.
