FDA Approves Expanded Indication for Johnson & Johnson's TRUFILL n-BCA System in Chronic Subdural Hematoma Treatment
核心洞察
The FDA has approved an expanded indication for Johnson & Johnson's TRUFILL n-BCA (搜索) Liquid Embolic System for middle meningeal artery (搜索) embolization as an adjunct to surgery in treating symptomatic chronic subdural hematoma (搜索).
The approval is supported by the MEMBRANE randomized controlled trial involving 376 patients, which demonstrated statistically significant treatment benefits compared to standard of care alone (P = .044).
Chronic subdural hematoma (搜索) affects older adults and anticoagulated patients, with traditional surgical approaches showing recurrence rates of 10-20%, creating an unmet medical need for alternative treatments.
Johnson & Johnson MedTech (搜索) announced that the U.S. Food and Drug Administration has approved an expanded indication for the TRUFILL n-BCA (搜索) Liquid Embolic System for embolization of the middle meningeal artery (搜索) (MMA) for the treatment of symptomatic subacute and chronic subdural hematoma (搜索) (cSDH) as an adjunct to surgery.
The approval addresses a significant unmet medical need in neurovascular care, where chronic subdural hematoma (搜索) often results from minor head trauma leading to bleeding between the dura and arachnoid membranes, particularly affecting older adults and those on anticoagulation therapy. While surgical intervention remains the traditional standard of care, recurrence rate estimates range between 10% to 20%.
MEMBRANE Trial Demonstrates Superior Efficacy
The FDA approval is supported by findings from the MEMBRANE randomized controlled trial, which evaluated the safety and effectiveness of MMA embolization in approximately 376 adult patients with cSDH. The prospective, multicenter, open-label, randomized-controlled trial enrolled participants across about 35 sites in the United States and China.
The study demonstrated that TRUFILL n-BCA (搜索) is superior in effectiveness compared to standard of care for embolization in the MMA for the treatment of symptomatic cSDH. Researchers observed a statistically significant treatment benefit with n-butyl cyanoacrylate compared with standard of care in patients treated with or without surgery (P = .044).
After demonstrating cSDH stability, participants were randomized in surgical or nonsurgical cohorts to receive standard-of-care with or without TRUFILL n-butyl cyanoacrylate MMA embolization. The primary trial endpoint was cSDH recurrence within 3 months of follow-up after surgery, while secondary endpoints comprised neurological deficits assessed by the modified Rankin Scale and recurrence- or intervention-associated complications during 3 months of follow-up.
Safety Profile and Clinical Outcomes
Additional findings revealed that endovascular MMA embolization was noninferior to standard of care alone for achieving good functional outcomes. Secondary efficacy, safety, and health economic outcomes generally favored embolization compared with standard of care alone. In terms of safety profile, adverse events were reported in 71.8% of patients in the embolization group and 65.3% of those receiving standard of care.
"There is an unmet need for new treatment options for chronic subdural hematoma (搜索), particularly for patients at risk of recurrence or complications from surgery," said Dr. Chris Kellner, Director of Cerebrovascular & Intercerebral Hemorrhage programs at Mount Sinai (搜索) 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."
Minimally Invasive Endovascular Approach
MMA embolization offers a minimally invasive endovascular approach by targeting smaller brain vessels thought to contribute to hematoma persistence and regrowth. This expanded indication brings TRUFILL n-BCA (搜索)'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.
TRUFILL n-BCA (搜索) has been a trusted solution in neurovascular embolization for over 25 years, supporting the treatment of patients with arteriovenous malformations (搜索) (AVMs) since its original FDA approval in 2000.
"This approval reinforces the enduring value of TRUFILL n-BCA (搜索) 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 (搜索).