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Onyx® is a non-adhesive liquid embolic agent used for the pre-surgical embolization of brain Arteriovenous malformations (bAVM).
- Onyx is comprised of EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy.
- The Onyx Liquid Embolic System (LES) consists of a 1.5 ml vial of Onyx, a 1.5 ml vial of DMSO, and three 1 ml Onyx delivery syringes.
- A DMSO compatible delivery micro catheter that is indicated for use in the neuro vasculature (e.g. Marathon™, Rebar® or UltraFlow™ HPC catheters) is used to access the embolization site.
- Onyx is available in two product formulations, Onyx 18 (6% EVOH) and Onyx 34 (8% EVOH).
- Onyx 18 will travel more distally and penetrate deeper into the nidus due to its lower viscosity compared to Onyx 34.
- Final solidification occurs within five minutes for both product formulations.
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Onyx LES is a device utilized for the pre-surgical embolization of arteriovenous malformations (AVM’s).
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
WARNINGS: Serious, including fatal, consequences could result with the use of the Onyx LES without adequate training. Contact your ev3 Sales Representative for information on training courses. Onyx Liquid Embolic System for AVMs Essential Product Information (EPI).
INDICATIONS FOR USE: Presurgical embolization of brain arteriovenous malformations (bAVMs). CONTRAINDICATIONS: The use of Onyx LES is contraindicated when any of the following conditions exist: 1. When optimal catheter placement is not possible; 2. When provocative testing indicates intolerance to the occlusion procedure; AND 3: When vasospasm stops blood flow. Onyx Liquid Embolic System for Onyx HD-500 Essential Product Information (EPI).
INDICATIONS FOR USE: Treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (≥ 4 mm) or with a dome-to-neck ratio < 2 that are not amenable to treatment with surgical clipping. Contraindications: The use of the Onyx LES is contraindicated when any of the following conditions exist: 1. When optimal catheter placement is not possible. 2. When vasospasm stops blood flow. Onyx is a registered trademark of Micro Therapeutics, Inc., d/b/a ev3 Neurovascular.