Medtronic expands cSDH treatment options with FDA clearance of Aristotle Mini Guidewire

Medtronic, a global leader in healthcare technology, announced the launch of the Aristotle® Mini Guidewire following U.S. Food and Drug Administration (FDA) 510(k) clearance in August 2026.

This clearance follows the recent FDA approval of the Onyx™ 12 Liquid Embolic System and further expands Medtronic's offerings for the treatment of chronic subdural hematoma (cSDH). cSDH is expected to become one of the most common neurosurgical conditions in adults by 2030, highlighting the need for continued innovation in access technologies. This launch expands the Aristotle guidewire portfolio with a lower-profile option designed to help physicians reliably reach the anatomy they need to treat.

In procedures such as middle meningeal artery (MMA) embolization, access is a critical first step. Physicians often need to navigate small, distal vessels before delivering therapy. Aristotle Mini is designed to support access to that anatomy as part of the full procedure that brings lower-profile navigation together with embolic therapy.

Built on Medtronic's proprietary microfabrication technology, Aristotle Mini is designed to provide structural integrity, steerability and control physicians need. It's compatible with 0.013-inch inner diameter microcatheter workflows, and complements Medtronic Neurovascular technologies, including Marathon™ and Apollo™ microcatheters and Onyx™ liquid embolic systems.

"As the burden of chronic subdural hematoma continues to grow, physicians need access to a range of technologies that help them treat increasingly complex anatomy," said Linnea Burman, Senior Vice President and President of the Neurovascular business, part of the Neuroscience portfolio at Medtronic. "Therapy begins with access and together with our broader portfolio of navigation, delivery and treatment technologies, Aristotle Mini reflects our commitment to advancing innovation across the entire neurovascular treatment journey."

Aristotle Mini may also support procedures involving arteriovenous malformations (AVMs) and dural arteriovenous fistulas (dAVFs), where physicians may need to navigate similarly small and distal vessels.

"MMA embolization can involve anatomy that varies considerably from patient to patient," said Dr. Adam Arthur, Chief Medical Officer for the Neurovascular business at Medtronic. "Having another lower-profile access option gives physicians more flexibility to choose the approach that best fits the anatomy and the procedure. Ultimately, that can help physicians deliver treatment more confidently and support better outcomes for patients with cSDH."

Aristotle Mini will be introduced through a phased commercial launch, with broader availability planned following initial physician experience.

The Aristotle portfolio of guidewires was originally developed by Scientia Vascular, which Medtronic acquired in June 2026. The acquisition added Scientia's neurovascular guidewires and catheters to Medtronic's existing treatment portfolio, expanding the company's ability to support physicians across the procedural workflow.

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.

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