Liquid Embolic Agents
Onyx Liquid Embolic System Onyx HD-500
Indications for Use
Onyx® Liquid Embolic System (Onyx® HD-500) is indicated for 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.
Key Specifications
- Non-adhesive liquid embolic agent comprised of EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide)
- Suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy
- Onyx HD-500 formulation: 9.4% EVOH by weight (also noted as 20% EVOH in supply section)
- System includes: 1.5 ml vial of Onyx HD-500, 1.5 ml vial of DMSO, one DMSO 1 ml delivery syringe, one threaded Onyx delivery syringe, and an interface device
- Model number: 105-8101-500
- Required accessories: HyperForm, HyperGlide, or Equinox Occlusion Balloon Systems (104-4000 Series); Rebar-14 Micro Catheter (105-5080-153)
- Delivered by slow controlled injection through a micro catheter under fluoroscopic control
- DMSO solvent dissipates into blood, causing EVOH copolymer and tantalum to precipitate in situ into a spongy, coherent embolus
- Forms a skin as the polymeric embolus solidifies from outside to inside, filling distally in the aneurysm
- Final solidification occurs within five minutes
- Priming volume for Rebar-14 Micro Catheter: 0.20 ml maximum
- Injection rate: Not to exceed 0.10 ml/min
- Minimum solidification time: 3 minutes
- Onyx and DMSO are sterile (dry heat) and non-pyrogenic; syringes and interface device are sterile and non-pyrogenic
- Intended for single use only; do not resterilize or reuse
- Storage: Cool dry place, maintain temperature between 19°C and 24°C prior to use
Description
The Onyx Liquid Embolic System (Onyx HD-500, Model 105-8101-500) is a non-adhesive liquid embolic agent comprised of EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide) and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy. It is delivered through a micro catheter to embolize aneurysms, where the DMSO dissipates, causing the copolymer and tantalum to precipitate into a spongy, coherent embolus that solidifies within five minutes.