EFFICACY

• Cohesive deposition and delivery

SIMPLICITY

• A slow controlled injection and delivery method
• Ability to stop and start the injection

ONYX™ LES IS AVAILABLE IN SEVERAL FORMULATIONS WITH VARYING FLOW PROPERTIES

The numerical term of Onyx™ LES describes its relative viscosity. OnyxTM LES is offered in 18 and 34 to provide options for controllable injections.

Presurgical embolization of brain arteriovenous malformations (bAVMs).

OnyxTM liquid embolic system is intended for presurgical embolization of brain arteriovenous malformations (bAVMs).

CAUTION

• U.S. federal law restricts the sale, distribution and use of this product to physicians or as prescribed by a physician.
• This product is for the exclusive use by medical specialists experienced in angiographic and percutaneous neurointerventional procedures.

PRECAUTIONS

• The safety and effectiveness has not been studied in the following patient populations:
• Pregnant and nursing women
• Individuals less than 18 years old
• Individuals with aneurysms not associated with a bAVM nidus, or distal feeders to a bAVM nidus or dural AV fistulas
• Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications.
• A garlic-like taste may be noted by the patient with use of the Onyx™ LES due to the DMSO component. This taste may last several hours. An odor on the breath and skin may be present.
• Inspect product packaging prior to use. Do not use if sterile barrier is open or damaged.
• Use prior to expiration date.
• Verify that the catheters and accessories (see directions for use) used in direct contact with the Onyx™ LES polymer are clean and compatible with the material and do not trigger polymerization or degrade with contact. Use only ev3 approved, Onyx™ LES/DMSO compatible micro catheters indicated for use in the neurovasculature and ev3 syringes. Other micro catheters or syringes may not be compatible with DMSO and their use can result in thromboembolic events due to catheter degradation. Refer to the Warnings and Directions for Use sections.
• Wait a few seconds following completion of the Onyx™ LES injection before attempting catheter retrieval. Failure to wait a few seconds to retrieve the micro catheter after the Onyx™ LES injection may result in fragmentation of the Onyx™ LES into non-target vessels.

CONTRAINDICATIONS

The use of the Onyx™ LES is contraindicated when any of the following conditions exist:

• When optimal catheter placement is not possible.
• When provocative testing indicates intolerance to the occlusion procedure.
• When vasospasm stops blood flow.

The following adverse events occurred using Onyx™ during a prospective, randomized, multi-center clinical trial for the presurgical treatment of bAVMs: Death, Headache +/- nausea and vomiting, Patient discomfort, Laboratory/Imaging abnormalities (Endocrine/Metabolic, Hematologic, Asymptomatic MRI/CT Findings, Respiratory/ Pulmonary, General, Gastrointestinal (GI)), Worsening Neurologic Status (Persistent, Resolved), Hyperglycemia, Infection, Bleeding and/or Low Hct requiring transfusion (Surgical Bleeding, Decreased Hct Requiring Transfusion), Intracranial Hemorrhage, Medication reaction, Failed access, Access site bleeding, Fever, Delivery Catheter removal difficulty, Poor penetration/visualization, Hypotension, Stroke, Cardiac arrhythmia, Hydrocephalus, SIADH (Syndrome of inappropriate antidiuretic hormone secretion, dilutional hyponatremia), Vessel Dissection, Hypertension, Limb ischemia, Respiratory failure, Seizures, UTI (Urinary tract infection), Vasospasm, Vaso-vagal episode, catheter shaft rupture, delivery catheter rupture, fragmentation of the Onyx™ LES, hypoxia, laryngospasm, peptic ulcer disease, psychotic episode, pulmonary edema, skin abrasion, subintimal injection, tachypnea, and tongue swelling.

Additional adverse events, which may be associated with embolization procedures include: Allergic reaction, Thrombocytopenia, Pulmonary embolism, Catheter entrapment, Catheter rupture, Device migration and cast movement, Hemorrhagic complications related to attempts to remove entrapped catheter.