Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA Liquid Embolic System to Treat Symptomatic Chronic Subdural Hematoma
Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (cSDH) as an adjunct to surgery.
cSDH is often caused by minor head trauma that leads to bleeding between the dura and arachnoid membranes, particularly among older adults and those on anticoagulation therapy. While surgical intervention is the traditional standard of care, recurrence rate estimates range between 10% to 20%.Embolization of the MMA offers a minimally invasive endovascular approach by targeting smaller brain vessels thought to contribute to hematoma persistence and regrowth.1
The approval is supported by findings from the MEMBRANE randomized controlled trial, which evaluated the safety and effectiveness of MMA embolization in patients with cSDH2. The results of the MEMBRANE study demonstrated that TRUFILL n-BCA is superior in effectiveness compared to Standard of Care (SOC) for embolization in the MMA for the treatment of symptomatic cSDHi, and importantly, TRUFILL n-BCA was demonstrated to be safe for treating cSDH2.
“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,” said Christian Cuzick, President, Worldwide Neurovascular, Johnson & Johnson MedTech.
“There is an unmet need for new treatment options for chronic subdural hematoma, particularly for patients at risk of recurrence or complications from surgery,” said Dr. Chris Kellnerii, Director of Cerebrovascular & Intercerebral Hemorrhage programs, Mount Sinai, and investigator in the MEMBRANE trial. “The MEMBRANE study demonstrated a positive treatment effect in favor of TRUFILL over standard of care and reinforces the potential of MMA embolization to improve outcomes for patients with cSDH.”
TRUFILL n-BCA has been a trusted solution in neurovascular embolization for over 25 years, supporting the treatment of patients with arteriovenous malformations (AVMs) since its original 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.
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Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information, visit https://www.jnjmedtech.com/en-US/companies/cerenovus and connect on LinkedIn.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. DePuy Synthes Sales, Inc. d/b/a CERENOVUS and Medical Device Business Services, Inc. are part of Johnson & Johnson MedTech.
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