Medtronic Onyx System Wins New FDA Nod for Chronic Subdural Hematoma Treatment

Reuters12-09 09:02

Medtronic Onyx System Wins New FDA Nod for Chronic Subdural Hematoma Treatment

Medtronic plc has announced a new U.S. indication for its Onyx™ Liquid Embolic System for embolization of the middle meningeal artery $(MMA)$ as an adjunct to surgery in the treatment of symptomatic subacute or chronic subdural hematoma (cSDH). The update follows results from the Medtronic-sponsored, multicenter, prospective, randomized EMBOLISE trial, which compared MMA embolization using Onyx™ as an adjunct to surgery versus surgical management alone. According to data initially presented at the 2024 International Stroke Conference and later published in the New England Journal of Medicine in November 2024, the use of Onyx™ LES with surgery resulted in approximately a 63% reduction in recurrence and re-operation rates. No device-related adverse events were observed up to 180 days, and there were no deaths attributed to the device or the procedure.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Medtronic plc published the original content used to generate this news brief on December 08, 2025, and is solely responsible for the information contained therein.

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