Johnson & Johnson's Liquid Embolic Agent TRUFILL n-BCA Receives FDA Approval for New Indication in Chronic Subdural Hematoma Treatment

Johnson & Johnson announces its liquid embolic agent---TRUFILL n‑BCANew Indication Approved by FDA.TRUFILL n‑BCAAs an adjunctive treatment for surgical procedures, used for middle meningeal artery (MMA) embolization to treat symptomatic subacute andChronic Subdural Hematoma (cSDH). The same indications, Medtronic's liquid embolic agentOnyx LESIt also received FDA approval for marketing last week.

TRUFILL n‑BCANew indications approved, based on studies conducted by Johnson & JohnsonMEMBRANE Randomized Controlled Trial. The study shows that in the treatment of symptomatic chronic subdural hematoma with middle meningeal artery embolization,TRUFILL n-BCA is more effective than the standard treatment regimenImportantly, studies have confirmed that TRUFILL n-BCA is safe for treating chronic subdural hematomas.

Expert Evaluation

"There is an unmet need for new treatment options for chronic subdural hematoma, especially for patients who face the risk of recurrence or potential surgical complications. The MEMBRANE study shows that, compared with standard treatment, TRUFILL n-BCA has positive therapeutic effects, further confirming the potential of middle meningeal artery embolization in improving the prognosis of patients with chronic subdural hematoma."

---Chris Kellner  Mount Sinai

Executive Evaluation

"This approval further solidifies the enduring value of TRUFILL n-BCA and reflects our commitment to delivering innovative technologies to improve patient outcomes and address complex neurovascular diseases."

---Christian Cuzick, President of Global Neurovascular Business, Johnson & Johnson Medical Technologies

Chronic subdural hematoma is typically caused by minor head trauma, leading to bleeding between the dura mater and arachnoid. It is particularly common in elderly populations and patients undergoing anticoagulation therapy. Although surgical intervention is the traditional standard treatment, its recurrence rate is estimated to be between 10% and 20%. Middle meningeal artery embolization, as a minimally invasive endovascular procedure, treats the condition by targeting smaller blood vessels believed to be associated with the persistence and recurrence of the hematoma.

TRUFILL n-BCAWith over 25 years of trusted experience in the field of neurovascular embolization, it has been supporting the treatment of patients with arteriovenous malformations since receiving its first FDA approval in 2000. This expanded indication now provides...TRUFILL n-BCAThe proven performance is applied to the treatment of chronic subdural hematoma, while traditional surgical intervention may not always be applicable or effective for long-term control of the condition.

TRUFILL n-BCA

TRUFILL n-BCAIt is a liquid embolic agent, which isComposed of n-Butyl Cyanoacrylate (n-BCA). Each setTRUFILL n-BCAEquipped with one or two 1g vials of TRUFILL n-BCA, one 1g vial of tantalum powder, and one 10ml vial of ethiodized oil.

• TRUFILL n-BCAThe polymerization time is relatively short. This characteristic makes the embolic agent particularly suitable for very high-flow arteriovenous shunts, such as Galen aneurysmal malformations and meningeal fistulas.
• With lower cost and shorter radiological examination time.

Johnson & Johnson has always been committed to addressing the most complex health challenges globally. For a century, we have driven the advancement of surgical care through innovative products such as wound closure, hemostasis assistance, surgical stapling devices, robotics, and digital solutions. Collaborating with clinical experts worldwide, we continuously revolutionize surgical techniques to better meet patient needs in metabolic diseases, cardiovascular diseases, oncology, and plastic reconstruction.