Medtronic announces new treatment option for chronic subdural hematoma (cSDH)

Medtronic plc, a global leader in healthcare technology, today announced that the Onyx™ Liquid Embolic System 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). This signals a significant step in cSDH patient treatment.

About the New Indication
The Medtronic-sponsored, multicenter, prospective and randomized EMBOLISE Trial compared MMAe using Onyx™ Liquid Embolic System (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 subsequently published in the New England Journal of Medicine in November 2024. The Onyx™ LES study demonstrated a decreased recurrence and re-operation 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 MMAe procedure.

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

About cSDH
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.

About the Neurovascular Business at Medtronic
Medtronic helped create the neurovascular market - introducing innovations like liquid embolic, stent retrievers, and flow diverters. Today, with products covering multiple conditions and disease states, we work to eliminate the burden of stroke and other neurovascular diseases globally by transforming care, one breakthrough at a time. Together with our partners, including physicians, hospitals, governments and patients, we're expanding into new disease states and stages of care. Our unwavering focus on better outcomes fuels our drive to deliver life-changing therapies and transform the future of care for patients worldwide. For more information, follow Medtronic Neurovascular on LinkedIn.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Erika Winkels
Public Relations - Neurovascular
[email protected]

Ingrid Goldberg
Investor Relations
[email protected]