Following CE-mark approval in February, Medtronic’s Onyx 12 liquid embolic system (LES) has entered its first patient cases with “promising early feedback” from physicians, according to the company.
Onyx 12 is CE-mark approved for embolisation of lesions in the neurovasculature, including arteriovenous malformations and hypervascular tumours. Medtronic states in a press release that the product delivers a “meaningful step forward” in procedural efficiency, requiring only one minute of shake time compared to the 20-minute preparation demand of existing tantalum-based products—without compromising performance.
“Building on more than 25 years of experience with Onyx LES, Onyx 12 reflects the practical improvements physicians continue to request in the treatment of malformations,” said Matt Sturt, vice president of neurovascular for Western Europe and region-led markets at Medtronic. “Developed in close collaboration with interventional neuroradiologists, this addition to the Onyx portfolio is designed to provide distal penetration while maintaining the control and visibility physicians rely on. Medtronic Neurovascular has helped shape the neurovascular field since its early days, and Onyx 12 represents the next chapter in that ongoing commitment.”
According to Medtronic, early-case physicians have noted particularly strong impressions in two critical areas: reflux control and distal penetration. The ability to precisely govern embolic delivery—limiting unintended reflux while achieving targeted distal reach—has been highlighted as a standout characteristic in early clinical experiences.
“Onyx 12 provided excellent visibility and enabled deep distal penetration while preserving proximal flow control,” commented Maxim Bester and Fabian Flottmann (both Universitätsklinikum Hamburg-Eppendorf [UKE], Hamburg, Germany).
Onyx 12’s radiopacity ensures clear fluoroscopic visualisation, giving physicians the confidence to monitor embolisation in real time, Medtronic also notes.
A full market release of Onyx 12 in the Western Europe region is now underway.
Additionally, on 29 April, Onyx 18 and 34 received US Food and Drug Administration (FDA) approval covering a one-minute shake time—with the same product performance—in the US market only. The previously approved shake time for these products was 20 minutes. Medtronic says Onyx 18 and 34 will also have updated packaging through this approval, which includes a reduction in plastic and improved ease of use.
