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<h2>Indications, Safety, and Warnings</h2> <h3>Caution<sup>1</sup></h3> <ul> <li>U.S. federal law restricts the sale, distribution and use of this product to physicians or as prescribed by a physician.</li> <li>This product is for the exclusive use by medical specialists experienced in angiographic and percutaneous neurointerventional procedures.</li> </ul> <h3>Indications for use</h3> <p>Presurgical embolization of brain arteriovenous malformations (bAVMs).</p> <h3>Contraindications</h3> <p>The use of the Onyx™ LES is contraindicated when any of the following conditions exist:</p> <ul> <li>When optimal catheter placement is not possible</li> <li>When provocative testing indicates intolerance to the occlusion procedure</li> <li>When vasospasm stops blood flow</li> </ul> <h3>Warnings</h3> <ul> <li>Due to the possibility of electrical arcing with the tantalum metal in the Onyx™ LES material, use of monopolar electrocautery devices for surgical resection of bAVMs or arteriovenous fistulas embolized with the Onyx™ LES should be avoided. Bipolar devices should be used with caution.</li> <li>The safety and effectiveness of the Onyx™ LES as a long term implant has not been established.</li> <li>Not for use with premature infants (<1,500 g) or individuals with significant liver and kidney function impairment.</li> <li>Performing embolization to occlude blood vessels is a high risk procedure. This device should be used only by physicians with neurointerventional training and a thorough knowledge of the pathology to be treated, angiographic techniques, and super-selective embolization.</li> <li>AVM embolization may influence blood flow patterns, thereby subjecting arteries supplying the AVM or the brain proximal to the AVM to increased pressures. Increased arterial pressures could result in hemorrhagic complications.</li> <li>Animal experimentation has shown that when the Onyx™ LES escapes outside the vascular space, as might occur if the vessel wall is compromised, a subacute inflammatory response to the material may occur. Increased intracranial pressure due to unresorbed Onyx™ LES material in this space may cause tissue damage.</li> <li>Dimethyl sulfoxide (DMSO) can initiate the liberation of histamine and there has been an occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide. This hypersensitivity has been reported in one patient being treated for interstitial cystitis. If anaphylactoid symptoms develop, appropriate therapy should be instituted.</li> <li>DMSO may interact with other embolic agents, such as polymer coated coils, e.g., gel coatings and suture material coated coils.</li> <li>Therapeutic embolization should not be performed when high blood flow precludes safe infusion of the embolic agent.</li> <li>The micro catheter tip should be placed so that embolization of the bAVM occurs distal to any arterial vessels that may supply normal brain tissue or cranial nerves.</li> <li>Failure to continuously mix the Onyx™ LES for the required time may result in inadequate suspension of the tantalum, resulting in inadequate fluoroscopic visualization during delivery (see instructions for use). Inject the Onyx™ LES immediately after mixing. If the Onyx™ LES injection is delayed, tantalum settling can occur within the syringe resulting in poor visualization of the Onyx™ LES during injection.</li> <li>Adequate fluoroscopic visualization must be maintained during the Onyx™ LES delivery or non-target vessel embolization may result. If visualization is lost at any time during the embolization procedure, HALT the Onyx™ LES delivery until adequate visualization is re-established.</li> <li>Premature solidification of the Onyx™ LES may occur if micro catheter luer contacts any amount of saline, blood or contrast.</li> <li>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.</li> <li>Use only thumb pressure to inject the recommended rate of 0.16 mL/ min. Do not exceed 0.3 ml/min injection rate. Animal studies have shown that rapid injection of DMSO into the vasculature may lead to vasospasm and/or angionecrosis. Using palm of hand to advance plunger may result in catheter rupture due to overpressurization in the event of catheter occlusion.</li> <li>Do not allow more than 1 cm of the Onyx™ LES to reflux back over catheter tip. Angioarchitecture, vasospasm, excessive Onyx™ LES reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment. Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage. The long-term effects of an entrapped catheter that is left in a patient are unknown, but potentially could include clot formation, infection, or catheter migration.</li> <li>After using a micro catheter with the Onyx™ LES, do not attempt to clear or inject any material through it. Such attempts may lead to embolus or embolization of an unintended area.</li> <li>STOP injection if the Onyx™ LES is not visualized exiting catheter tip. If the catheter becomes occluded, over-pressurization can occur. During the Onyx™ LES injection, continuously verify that the Onyx™ LES is exiting the catheter tip. Testing has shown that over-pressurization and rupture can occur if only a volume of 0.05 ml of the Onyx™ LES is injected and is not visualized exiting the catheter tip.</li> <li>STOP injection if increased resistance to the Onyx™ LES injection is observed. If increased resistance occurs, determine the cause (e.g., Onyx™ LES occlusion in catheter lumen) and replace the catheter. Do not attempt to clear or overcome resistance by applying increased injection pressure, as use of excessive pressure may result in catheterrupture and embolization of unintended areas.</li> <li>DO NOT interrupt the Onyx™ LES injection for longer than two minutes prior to re-injection. Solidification of the Onyx™ LES may occur at the catheter tip resulting in catheter occlusion, and use of excessive pressure to clear the catheter may result in catheter rupture.</li> <li>Verify that adequate sedation is used throughout the embolization procedure. Insufficient sedation may result in patient discomfort or movement. Patient movement during embolic agent injection may result in embolization of an unintended vessel.</li> <li>Failure to continuously mix the Onyx™ LES for the required time may result in inadequate suspension of the tantalum, resulting in inadequate fluoroscopic visualization during delivery.</li> <li>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.</li> <li>Use only the ev3 1 ml syringe to inject DMSO and the Onyx™ LES. Other syringes may not be compatible with DMSO.</li> <li>Premature solidification of the Onyx™ LES may occur if micro catheter luer contacts saline, blood or contrast of any amount.</li> <li>Inject Onyx™ LES immediately after mixing. If the Onyx™ LES injection is delayed, tantalum settling can occur within the syringe resulting in poor visualization of Onyx™ LES during injection.</li> <li>Do not exceed 0.3 ml/min injection rate. Animal studies have shown that rapid injection of DMSO into the vasculature may lead to vasospasm and/or angionecrosis.</li> <li>Only use thumb pressure to inject the Onyx™ LES. Using palm of hand to advance plunger may result in catheter rupture due to overpressurization in the event of catheter occlusion.</li> <li>Adequate fluoroscopic visualization must be maintained during the Onyx™ LES delivery or non-target vessel embolization may result. If visualization is lost at any time during the embolization procedure, HALT the Onyx™ LES delivery until adequate visualization is re-established.</li> <li>Do not allow more than 1 cm of the Onyx™ LES to reflux back over catheter tip.</li> <li>Angioarchitecture, vasospasm, excessive Onyx™ LES reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment.</li> <li>Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.</li> <li>The long-term effects of an entrapped catheter that is left in a patient are unknown, but potentially could include clot formation, infection, or catheter migration.</li> <li>After using a micro catheter with the Onyx™ LES, do not attempt to clear or inject any material through it. Such attempts may lead to embolus or embolization of an unintended area.</li> <li>STOP injection if the Onyx™ LES is not visualized exiting catheter tip. If the catheter becomes occluded, over-pressurization can occur. During the Onyx™ LES injection, continuously verify that the Onyx™ LES is exiting the catheter tip. Testing has shown that overpressurization and rupture can occur if 0.05 ml of the Onyx™ LES is injected and is not visualized exiting the catheter tip.</li> <li>STOP injection if increased resistance to the Onyx™ LES injection is observed. If increased resistance occurs, determine the cause (e.g., the Onyx™ LES occlusion in catheter lumen) and replace the catheter. Do not attempt to clear or overcome resistance by applying increased injection pressure, as use of excessive pressure may result in catheter rupture and embolization of unintended areas.</li> <li>DO NOT interrupt the Onyx™ LES injection for longer than two minutes prior to re-injection. Solidification of the Onyx™ LES may occur at the catheter tip resulting in catheter occlusion, and use of excessive pressure to clear the catheter may result in catheter rupture.</li> </ul> <h3>Precautions</h3> <ul> <li>The safety and effectiveness has not been studied in the following patient populations:<ul> <li>Pregnant and nursing women</li> <li>Individuals less than 18 years old</li> <li>Individuals with aneurysms not associated with a bAVM nidus, or distal feeders to a bAVM nidus or dural AV fistulas</li> </ul> </li> <li>Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications.</li> <li>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.</li> <li>Inspect product packaging prior to use. Do not use if sterile barrier is open or damaged.</li> <li>Use prior to expiration date.</li> <li>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.</li> <li>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.</li> </ul> <p><b>Difficult catheter removal or catheter entrapment may be caused by any of the following</b>:</p> <ul> <li>Angioarchitecture: very distal bAVM fed by afferent, lengthened, small, or tortuous pedicles</li> <li>Vasospasm</li> <li>Reflux</li> <li>Injection time</li> </ul> <p>To reduce the risk of catheter entrapment, carefully select catheter placement and manage reflux to minimize the factors listed above.</p> <p><b>Should catheter removal become difficult, the following will assist in catheter retrieval:</b></p> <ul> <li>Carefully pull the catheter to assess any resistance to removal.</li> <li>If resistance is felt, remove any “slack” in the catheter.</li> <li>Gently apply traction to the catheter (approximately 3–4 cm of stretch to the catheter).</li> <li>Hold this traction for a few seconds and release. Assess traction on vasculature to minimize risk of hemorrhage. </li> <li>This process can be repeated intermittently until catheter is retrieved.</li> </ul> <p><b>Alternate technique for difficult to remove catheters:</b></p> <ul> <li>Remove all slack from the catheter by putting a few centimeters of traction on the catheter to create a slight tension in the catheter system.</li> <li>Firmly hold the catheter and then pull it using a quick wrist snap motion (from left to right) 10–15 centimeters to remove the catheter from the Onyx™ LES cast. (Note: Do not apply more than 20 cm of traction to catheter, to minimize risk of catheter separation.)</li> </ul> <p><b>For entrapped catheters:</b></p> <ul> <li>Under some difficult clinical situations, rather than risk rupturing the malformation and consequent hemorrhagic complications by applying too much traction on an entrapped catheter, it may be safer to leave the micro catheter in the vascular system.</li> <li>This is accomplished by stretching the catheter and cutting the shaft near the entry point of vascular access allowing the catheter to remain in the artery.</li> <li>If the catheter breaks during removal, distal migration or coiling of the catheter may occur. Same day surgical resection should be considered to minimize the risk of thrombosis.</li> </ul> <h3>Adverse Events: Potential Adverse Effects of the Device on Health</h3> <ul> <li>A prospective, randomized, multi-center clinical trial compared Onyx™ LES to the TRUFILL™ n-Butyl cyanoacrylate (TRUFILL™ NBCA) liquid embolic system for the presurgical treatment of bAVMs. The primary endpoint of the study required 100 patients to be evaluated for effectiveness. An additional 17 patients were enrolled under a continued access provision. Safety was evaluated for all 117 patients in the Intention to Treat (ITT) cohort, which includes all patients in which treatment of the assigned device was attempted. Safety was assessed based on the nature and severity of adverse events.</li> <li>The safety profile for the two groups was comparable. Many of the events occurred during, or post surgery, as opposed to during, or post embolization, with the embolization agents.</li> <li>Two patients died during the course of the clinical trial. Both deaths occurred in the Onyx™ LES group and both occurred following surgical resection. A third death occurred after the patient had been discharged to a rehabilitation center for persistent neurological deficits, but the patient had completed study follow-up.</li> </ul> <p>The following events occurred in one patient each in the Onyx™ LES group and did not occur in the TRUFILL™ NBCA group: 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. The following events occurred in one patient each in the TRUFILL™ NBCA group, and did not occur in the Onyx™ LES group: catabolic state, coagulopathy, corneal abrasion, elective carotid aneurysm surgery, high flow fistula, multi-organ system complications, myopathy/neuropathy, orthostasis, post craniotomy revision, surgical revision, transient ischemic attack (TIA), trauma, ureteral perforation, and vocal cord paralysis</p> <h3>Additional adverse events, which may be associated with embolization procedures include:</h3> <ul> <li> Allergic reaction</li> <li>Thrombocytopenia</li> <li>Pulmonary embolism</li> <li>Catheter entrapment</li> <li>Catheter rupture</li> <li> Device migration and cast movement</li> <li>Hemorrhagic complications related to attempts to remove entrapped catheter</li> </ul> <h3>Training:</h3> <p>Serious, including fatal, consequences could result with the use of the Onyx™ LES without adequate training. Onyx™ LES implantation should only be performed by physicians who have successfully completed training in the use of Onyx™ LES. Contact your Medtronic sales representative for information on training courses.</p> <hr /> <p>Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.</p> <p>1 Onyx™ Liquid Embolic System IFU, 70862-001 Rev. 10/13.</p> <p>US-NNP-2400104 (v1.0)</p>

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