Healthcare Professionals

Onyx<sup>TM</sup> Liquid Embolic System

Peripheral Embolization

Overview

The Onyx™ Liquid Embolic System (LES) is an ethylene vinyl alcohol (EVOH) copolymer that provides complete filling and distal penetrationof peripheral. Its non-adhesive properties permit more distal nidus embolization without significant risk of catheter entrapment, while higher viscosities allow for controlled deployment.2

INDICATIONS

OnyxTM 18 & 34 LES: Embolization of lesions in the peripheral including arteriovenous malformations and hypervascular tumors.

OnyxTM 34L  LES: Embolization of lesions in the peripheral vasculature, including endoleaks, arteriovenous malformations, portal veins, bleeding and tumors. 

PRODUCT DETAILS

OnyxTM is a non-adhesive liquid embolic agent composed of EVOH dissolved in DMSO with suspended micronised tantalum powder. It is delivered through a microcatheter under fluoroscopic control.

Polymeric properties

  • Precipitation occurs on contact with aqueous solution (e.g., blood, water, contrast)
  • Flows like lava and solidifies from the outside in as solvent diffuses away
  • Delivers in a cohesive manner, forming a spongy, coherent embolus

Controlled delivery

  • Slow controlled injection and delivery method
  • Ability to start and stop injections (pauses should not exceed 2 minutes)
  • Cohesive deposition and delivery
  • Excellent visibility3
  • Controlled angiography during embolic injection

Formulations

OnyxTM 18 and 34 LES for peripheral use:

  • OnyxTM 18 LES (6% EVOH, viscosity of 18 cSt) will travel more distally and penetrate deeper into the targeted lesion due to its lower viscosity compared to OnyxTM 34 (i.e. peripheral AVM nidus)
  • OnyxTM 34 LES (8% EVOH, viscosity of 34 cSt) with higher viscosity for more control in higher flow and large fistulous components

OnyxTM 34L LES for peripheral use:

  • 8% EVOH, viscosity of 34 cSt
  • Lower tantalum content than current version of OnyxTM 34 LES4
  • Less streak artifact on CT with good visibility during injection4

OnyxTM 34L LES packaging with 6 ml vial

  • 6 ml vial provides ease of use for large volume treatments
  • Requires less storage space than four 1.5 ml vials of OnyxTM 34 LES
  • Environmentally friendly packaging made from 98% recyclable content

CT Validation*

  • OnyxTM 34L LES has less streak artifact on CT with good visibility during injection in comparison to OnyxTM 34 LES4


OnyxTM 34L LES in 10mm vessel


OnyxTM 34 LES in 10 mm vessel

Model Specifications

OnyxTM Liquid Embolic System

Product Code OnyxTM Formulation

105-7200-060

OnyxTM 18 Peripheral Kit, 1.5 ml

105-7200-080

OnyxTM 34 Peripheral Kit, 1.5 ml

105-7315-080

OnyxTM 34L Kit, 1.5 ml

105-7360-080

OnyxTM 34L Kit, 6 ml

OnyxTM LES Accessories

Product Code OnyxTM LES Accessory

103-1205-001

Vortex Genie 2 120v/60Hz with 1.5mL vial attachment

103-1205-002

Vortex Genie 2 240v/50Hz with 1.5mL vial attachment

103-1205-100

Mixer Attachment for 6mL and 1.5mL vials

103-1207

Syringe Catheter Interface Adapter
(20 units/box)

103-1203

1 ml Luer-Lock Injector Syringe
(10 units/box)

MANUALS AND TECHNICAL GUIDES

The technical manual includes indications, warnings, precautions, MRI information, and directions for use. Find it in the product labeling supplied with each device.

MRI Information

Non-clinical testing demonstrated that the OnyxTM Liquid Embolic System is MR conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions:

Static magnetic field:

  • Static magnetic field of 1.5-Tesla or 3-Tesla
  • Maximum spatial gradient magnetic field of 720-Gauss/cm or less.
*

CT artifact validation in vitro using a water phantom tank to simulate body tissue and synthetic vessel document TR_NV 11300 RevA

Images are property of Medtronic.

1

Jose Urbano, MD, PhD Selective Arterial Embolization with Ethylene–Vinyl Alcohol Copolymer for Control of Massive Lower Gastrointestinal Bleeding: Feasibility and Initial Experience. J Vasc Interv Radiol 2014.

2

Ricardo Yamada, Andre Uflacker, Austin Bourgeois, Joshua D. Adams, Marcelo Guimaraes, ‘EVOH/DMSO in Peripheral Application’ in Embolization Therapy: Principles and Clinical Applications, ed. Marcelo Guimaraes, Riccardo Lencioni, and Gary P. Siskin (Philadelphia, Wolters Kluwer, 2015), 582 pp. 

3

Perez-Higueras, A. et al. Endovascular Treatment of Cerebral AVM:Our Experience with Onyx. Interventional Neuroradiology 11:141-157,2005.

4

IFU 70721-001 Rev 01/13. 2 CT artifact validation in vitro using a water phantom tank to simulate body tissue and synthetic vessel Document TR_NV 11300 RevA 2013-08-20. All images property of Covidien.