The FDA granted clearance to Medtronic’s Onyx liquid embolic system for embolization of the middle meningeal artery as an adjunct to surgery in symptomatic subacute or chronic subdural hematoma, citing data from the randomized EMBOLISE trial. The decision adds a device-based adjunct to neurosurgical workflows for a common, often recurrent neurosurgical condition. Medtronic framed the clearance as expanding interventional options and enabling clinicians to use endovascular embolization alongside surgical evacuation. Hospitals and device procurement teams will assess procedural adoption, coding and reimbursement implications. Device makers and investors will watch post‑market performance and real‑world utilization closely.
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