Medtronic’s Onyx LES OK’ed to Treat Chronic Subdural Hematoma

Medtronic announced that its Onyx liquid embolic system (LES) is now indicated in the U.S. for embolization of the middle meningeal artery (MMA) as an adjunct to surgery to treat symptomatic subacute or chronic subdural hematoma (cSDH).

The new indication is based on a Medtronic-sponsored, multicenter, prospective, and randomized trial called EMBOLISE. The trial compared MMA embolization using the Onyx LES as an adjunct to surgery with surgical management alone for symptomatic subacute and chronic SDH.

cSDH, or chronic subdural hematoma, is a collection of blood between the brain’s dura and arachnoid mater that develops slowly over a period of days or weeks, usually following trauma. It commonly occurs in older people, and it can lead to severe complications if left untreated.

The EMBOLISE trial’s results were first presented at the 2024 International Stroke Conference and subsequently published in the New England Journal of Medicine in November 2024. The study showed decreased recurrence and re-operation of about 63% when combined with surgery.

Further, there were no Onyx device-related adverse events up to 180 days and no deaths were attributed to Onyx or the MMAe procedure.

“This expansion reflects Medtronic’s ongoing commitment to innovation, grounded in evidence and designed around safety and outcomes,” the company said in a press release. “Our dedicated Principal Investigators and research teams continue to analyze the EMBOLISE trial data, providing further insights to advance cSDH treatment.”

In July, the company enrolled the first patient in its PEripheral Onyx Liquid Embolic (PELE) clinical trial, which is evaluating Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature.