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May 19, 2026
FDA Approves Reduced Shake Time for Medtronic’s Onyx 18 and Onyx 34
KEY TAKEAWAYS
- FDA approves new shake time and packaging for Medtronic’s Onyx LES, Onyx 18 and Onyx 34.
- Newly approved time of at least 1 minute provides same product performance as previously approved shake time of 20 minutes.
- Onyx 18 and Onyx 34 are indicated for presurgical embolization of brain arteriovenous malformations and for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma.
May 19, 2026—Medtronic Neurovascular announced that its Onyx Liquid Embolic System (LES), Onyx 18 and Onyx 34, received FDA approval for a shake time of at least 1 minute with the same product performance.
The previously approved shake time for these products was 20 minutes. The new approval applies only to the United States market, advised the company.
The packaging for Onyx 18 and Onyx 34 will be updated through this approval and will include a reduction in plastic and improved ease of use, noted Medtronic.
The company stated that Onyx 18 LES and Onyx 34 LES are indicated for presurgical embolization of brain arteriovenous malformations and for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma.
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