FDA Approves J&J Device for Common Brain Bleed, Heralding New Era

IRVINE, CA – December 18, 2025 – By Angela Gray

The U.S. Food and Drug Administration (FDA) today approved an expanded use for a Johnson & Johnson MedTech device, signaling a significant advancement in the treatment of chronic subdural hematoma (cSDH), a common and often recurring type of brain bleed prevalent among the elderly. The approval grants the TRUFILL n-BCA Liquid Embolic System a new indication for use as an adjunct to surgery, targeting the root cause of hematoma regrowth through a minimally invasive procedure.

This decision, which follows a successful landmark clinical trial, provides a powerful new tool for neurosurgeons and interventional specialists battling a condition notorious for its high recurrence rate. For decades, the standard of care has been surgical drainage, but this new approach offers a way to prevent the bleed from returning, potentially transforming long-term outcomes for a vulnerable patient population.

A New Front in Treating a 'Silent Epidemic'

Chronic subdural hematoma is often referred to as a “silent epidemic.” It involves a slow accumulation of blood between the brain and its outer lining, the dura mater. The condition is frequently triggered by a minor head injury—sometimes so trivial the patient doesn’t recall it—and is particularly common in older adults, whose brains have naturally shrunk slightly, leaving more space for veins to stretch and tear. The widespread use of blood thinners further elevates this risk.

Symptoms can be insidious and easily mistaken for other age-related conditions, including confusion, headaches, difficulty walking, and weakness. While surgical drainage, most often through small openings in the skull known as burr-holes, is effective at removing the initial blood collection, it fails to address the underlying pathology. The inflammatory response to the initial bleed causes the formation of new, fragile blood vessels in the dura mater, which continuously leak fluid and blood, leading to a recurrence in an estimated 10% to 20% of cases. These recurrences often necessitate repeat surgeries, increasing risks and hospital stays for patients who are already medically fragile.

The newly approved approach, known as middle meningeal artery (MMA) embolization, tackles this problem head-on. Instead of just draining the existing blood, interventional specialists can now use the TRUFILL system to block the MMA, the primary artery supplying blood to the problematic outer membrane. By threading a microcatheter through blood vessels from the wrist or groin up to the head, physicians can inject the TRUFILL liquid, which solidifies and cuts off the blood supply to the leaky vessels. This helps the membrane heal and dramatically reduces the chance of the hematoma refilling.

Landmark Trial Validates Minimally Invasive Approach

The FDA’s decision was heavily supported by robust data from the MEMBRANE randomized controlled trial, which evaluated the safety and effectiveness of MMA embolization with TRUFILL n-BCA. The study demonstrated a statistically significant and superior outcome for patients who received the embolization compared to those who received the standard of care alone. The trial's primary endpoint—measuring hematoma recurrence or the need for re-operation within six months—showed a clear advantage for the minimally invasive technique.

"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 Kellner, Director of Cerebrovascular & Intercerebral Hemorrhage programs at Mount Sinai and an 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 is not a new product but a trusted tool with a long track record. It has been used by neurovascular specialists for over 25 years, having first received FDA approval in 2000 for treating arteriovenous malformations (AVMs), another complex brain vessel condition. This history provides a foundation of reliability and familiarity for physicians, which is expected to facilitate quicker adoption of the procedure for this new indication.

"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 of Worldwide Neurovascular at Johnson & Johnson MedTech, in a statement.

Shifting Tides in the Neurovascular Market

This approval positions Johnson & Johnson MedTech at the forefront of a rapidly evolving market. The global neurovascular device market is projected to exceed $7 billion by 2030, driven by an aging population and a push towards less invasive technologies. The cSDH treatment market itself is a multi-billion dollar segment ripe for innovation.

Johnson & Johnson is not alone in this space. Competitor Medtronic also recently secured an expanded indication for its Onyx™ Liquid Embolic System for the same purpose, based on its own successful EMBOLISE trial. The presence of multiple, large-scale randomized trials and competing FDA-approved products underscores the clinical community's confidence in MMA embolization and signals a paradigm shift in treatment. For Johnson & Johnson, this approval solidifies its standing as a leader in neurovascular care and aligns with its broader corporate strategy of investing in high-growth sectors with significant unmet medical needs.

Beyond the Scalpel: The Future of Brain Interventions

The rise of MMA embolization for cSDH is part of a larger trend across medicine: the move away from open surgery toward minimally invasive, endovascular solutions. From treating heart attacks with stents to repairing aortic aneurysms with grafts, catheter-based procedures have revolutionized patient care by reducing risk, minimizing pain, and shortening recovery times. Neurovascular intervention is the latest frontier for this transformation.

For elderly cSDH patients, the benefits are particularly profound. A minimally invasive procedure that can be performed under light sedation carries far fewer risks than an open operation under general anesthesia. It can mean the difference between a few weeks of recovery and a prolonged hospital stay fraught with potential complications. While the current approval is for use as an adjunct to surgery, many experts believe that for certain patients—such as those with smaller hematomas or who are too frail for surgery—MMA embolization could one day become a standalone primary treatment.

With robust clinical data now backing the procedure and two major industry players offering FDA-approved solutions, the stage is set for rapid adoption in hospitals across the country. This evolution in care promises not only to reduce the burden of repeat surgeries but also to offer a better, safer, and more durable solution for a growing number of patients facing this challenging neurological condition.