December 11, 2025

Medtronic’s Onyx Liquid Embolic System Approved for Chronic Subdural Hematoma Indication

December 11, 2025—Medtronic announced that the Onyx liquid embolic system (LES)—Onyx 18 and Onyx 34—is now indicated in the United States for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).

According to Medtronic, the company-sponsored, multicenter, prospective, and randomized EMBOLISE trial compared MMA embolization using the Onyx LES as an adjunct to surgery with surgical management alone for symptomatic subacute and chronic SDH.

Results from the EMBOLISE trial were initially presented at the 2024 International Stroke Conference and published in November 2024 by Jason M. Davies, MD, et al in The New England Journal of Medicine (2024;391:1890-1900).

Medtronic stated that the Onyx LES demonstrated a decreased recurrence and reoperation of about 63% when combined with surgery. In addition, there were no Onyx device-related adverse events up to 180 days and no deaths attributed to Onyx LES or the MMA embolization procedure.

Principal investigators and research teams continue to analyze the EMBOLISE trial data to provide further insights to advance chronic SDH treatment, advised Medtronic.

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December 11, 2025

Medtronic’s Onyx Liquid Embolic System Approved for Chronic Subdural Hematoma Indication

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