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2025Year12Month18Day,Medtronic (NYSE:MDT) and Johnson & Johnson Medical Technology (NYSE:JNJ) simultaneously announced its liquid embolic system (LES) Obtain the U.S. Food and Drug Administration (FDA) Expanded indication approval for adjuvant treatment of symptomatic subacute and chronic subdural hematoma (cSDH）。This is an important regulatory milestone in the field of neurovascular embolization, marking a breakthrough in the application of this technology in neurosurgery.

Medtronic disclosed,ItsOnyxLiquid Embolic System (LES) Earlier this month, it has been approved.FDAApproved, becoming the first to assist in treatmentSDH/cSDHCommercial Product for Middle Meningeal Artery Embolization. The system uses ethylene vinyl alcohol (EVOH) Copolymer technology,With unique non-adhesive properties——When delivered through a microcatheter under fluoroscopic guidance, it achieves deep embolization of distal neurovasculature while avoiding the risk of catheter retention. Its high-viscosity property ensures precise and controllable deployment.

Supporting this expansionEMBOLISEThe test data shows that the adoption ofOnyxPerforming middle meningeal artery embolization (MMA`) Combined surgery, compared to simple surgical treatment, can make`180The recurrence rate and reoperation rate within days decreased.63%More crucially, the study observed no device-related adverse events or treatment-related deaths. The Medtronic chief research team is continuing to analyze the trial data to uncover more clinical application value. The company emphasized that this achievement confirms its innovation philosophy of "safety and efficacy as the core."

Approved by Medtronic10Empress of Heaven,Johnson & Johnson Medical Technology announced itsTruFill n-BCALiquid embolization system also obtainedFDAYescSDHExtended Indications for Treatment.The product is based on existing25Years of clinical validationn-BCATechnology, previously obtainedFDAApproved for the treatment of arteriovenous malformations. This expansion is based onMEMBRANEClinical trials have shown that its efficacy is significantly better than the standard care regimen, and its safety has been fully validated.

President of Global Neurovascular, Johnson & Johnson Medical TechnologiesChristian CuzickSaid: "This approval not only consolidatesTruFill n-BCAThe leading position in the neurovascular field further demonstrates our commitment to improving outcomes for patients with complex neurovascular diseases through innovative technologies." The system precisely targets small cerebral vessels via a minimally invasive endovascular approach, effectively blockingcSDHPersistent bleeding and regeneration of hematomas - These types of hematomas are often caused by minor head trauma-induced epidural hemorrhages.-Caused by subarachnoid hemorrhage.

This dual approval marks a significant expansion of liquid embolization technology from traditional vascular malformation treatment into the field of traumatic intracerebral hemorrhage. Both companies emphasized that they will continue to advance clinical research to optimize treatment pathways and explore new indications such as peripheral vascular bleeding. WithEMBOLISEAndMEMBRANEIn-depth analysis of experimental data promises clinicians more precise surgical assistance tools, thereby improving the cure rate and quality of life for patients with chronic subdural hematomas.

Currently, both companies have initiated programs targetingcSDHClinical training programs for treatment to ensure the standardized application of new indications. Industry observers pointed out that this breakthrough might reshape the standards of neurosurgery, benefiting more than a million cases globally each year.cSDHProvide patients with safer and more effective treatment options.