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November 10, 2026
Medtronic’s Aristotle Mini Guidewire Cleared by FDA
KEY TAKEAWAYS
- Medtronic launches Aristotle Mini guidewire after receiving FDA 510(k) clearance in August 2026.
- The guidewire is designed for navigation of small, distal vessels and is compatible with 0.013-inch inner diameter microcatheters.
- The device expands Medtronic’s neurovascular portfolio after the FDA approval of Onyx 12.
November 10, 2026—Medtronic announced the launch of the Aristotle Mini guidewire, which received FDA 510(k) clearance in August 2026. Aristotle Mini will be introduced through a phased commercial launch, with broader availability planned after initial physician experience, advised Medtronic.
The company noted that the launch expands the Aristotle guidewire portfolio with a lower-profile option intended to help physicians reliably reach the anatomy they need to treat in procedures such as middle meningeal artery embolization and the treatment of arteriovenous malformations and dural arteriovenous fistulas, where physcians may 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.
Medtronic advised that FDA clearance of Aristotle Mini came after FDA approval of the Onyx 12 liquid embolic system and further expands the company’s product offering for the treatment of chronic subdural hematoma.
Aristotle Mini is built on Medtronic’s microfabrication technology and is designed to provide structural integrity, steerability, and control. It is compatible with 0.013-inch inner diameter microcatheter workflows and complements Medtronic Neurovascular technologies, including the Marathon and Apollo microcatheters and Onyx liquid embolic systems, stated the company.
The Aristotle portfolio of guidewires was originally developed by Scientia Vascular, which Medtronic acquired in June 2026, noted the company’s press release.
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