Liquid Embolic Agents
Onyx® Liquid Embolic System
Indications for Use
Onyx® Liquid Embolic System (Onyx®HD-500) (hereinafter called the Onyx® HD-500 System and Onyx®) 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) and suspended micronized tantalum powder for fluoroscopic visualization
- Formulation: Onyx® HD-500 (9.4% EVOH by weight)
- Components: 1.5 ml vial of Onyx® HD-500, 1.5 ml vial of DMSO, one DMSO 1ml delivery syringe, one threaded Onyx® delivery syringe, and an interface device
- Required accessories: HyperForm™ or HyperGlide™ or Equinox Occlusion Balloon Systems (104-4000 Series), Rebar-14 Micro Catheter (105-5080-153)
- Delivery: Slow controlled injection through a micro catheter into the aneurysm under fluoroscopic control at a maximum rate of 0.1 ml/min with Rebar micro-catheter
- Mechanism: DMSO solvent dissipates into blood, causing EVOH copolymer and tantalum to precipitate in situ into a spongy, coherent embolus
- Precipitation: Immediately forms a skin, solidifies from outside to inside while filling distally, final solidification within 5 minutes
- Radiopacity: Adequate when compared to stainless steel guidewire
- Injection pressures: Well below burst pressure specification of Rebar catheter at 0.1 and 0.2 ml/min at 37°C
- Run-on characteristics: Continues to infuse at approximately 0.003 ml/min over 4 minutes after injection halt, total increase of approximately 12 μl
- Particulate generation: Less than maximum allowable per USP XXV <788>
- Material expansion: Diameter remains stable from day 1 to day 7; tensile strength 0.5-6.0 psi
- Adhesion: Rebar catheter removal force significantly less than break force
- Radiation effects: Unaffected by 30 Gray radiation followed by 210 days aging at 55°C
- Compatibility: Chemically compatible with delivery devices; no leachates from coils or cyanoacrylate
- Sterilization: Dry heat for Onyx® and DMSO (SAL 10^-6); Ethylene Oxide for syringes
- Shelf life: 3 years based on accelerated and real-time aging tests
- Biocompatibility: Meets ISO 10993-1 for permanent implants and blood contact; additional testing per FDA guidance for long-term neurological implants
Description
Onyx® Liquid Embolic System (Onyx® HD-500), referred to as Onyx®, 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. The Onyx® HD-500 System includes a 1.5 ml vial of Onyx® HD-500, a 1.5 ml vial of DMSO, one DMSO 1ml delivery syringe, one threaded Onyx® delivery syringe and an interface device. The following DMSO compatible accessory devices are required for use with the Onyx® HD-500 System: HyperForm™ or HyperGlide™ or Equinox Occlusion Balloon Systems (104-4000 Series), Rebar-14 Micro Catheter (105-5080-153). The Onyx® HD-500 System for the embolization of aneurysms is available in one product formulation, Onyx® HD-500 (9.4% EVOH by weight). Onyx® is delivered by slow controlled injection through a micro catheter into the aneurysm under fluoroscopic control. The DMSO solvent dissipates into the blood, causing the EVOH copolymer and suspended tantalum to precipitate in situ into a spongy, coherent embolus. Onyx® immediately forms a skin as the polymeric embolus solidifies from the outside to the inside, while filling more distally in the aneurysm. Final solidification of this material occurs within five minutes.