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Complete Issue (PDF) DECEMBER 2018 AJNR VOLUME 39 • PP 2167–2388 DECEMBER 2018 THE JOURNAL OF DIAGNOSTIC AND VOLUME 39 INTERVENTIONAL NEURORADIOLOGY NUMBER 12 WWW.AJNR.ORG Differentiating brain tumor progression from pseudoprogression Endoscopic third ventriculostomy evaluation with CISS Transdural blood supply in cerebral arteriovenous malformations Official Journal ASNR • ASFNR • ASHNR • ASPNR • ASSR ® Aneurysm Therapy LVIS Solutions Intraluminal Support Device The first and only stent with Premarket Approval (PMA) for use in stent-assisted coil embolization Stent Deployment. Refined. 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The HES and MCS are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The device should only be used by physicians who have undergone pre-clinical training in all aspects of HES/MCS procedures as prescribed by MicroVention. A Complete Coil Portfolio Hydrogel Embolic Coils & Platinum Coils MicroVention’s comprehensive portfolio features clinically proven Hydrogel coils, which can be used exclusively or in combination with our trusted Platinum coils to treat a wide range of aneurysms and neurovascular lesions. Breakthrough Hydrogel Technology • Less Recurrence • Less Retreatment • More Progressive Occlusion Compared to platinum coils with comparable safety1 RER FEERENCESE : 1.. TTaschner eet al.. Seconco d-Generattion Hydrooggel Coils for the Endovascular Treaeatmemenenntto of Intracrananial AAneurryysmm; A RaR nndod mizizi edd CControllelledTd Tririaial.i l 2018;49:000-0-00.0 DOII:100.116161// STROKOKEAHAHA.117.0187077 For more information or a product demonstration, MicroVention Worldwide contact your local MicroVention representative: Innovation Center PH +1.714.247.8000 35 Enterprise Aliso Viejo, CA 92656 USA MicroVention UK Limited PH +44 (0) 191 258 6777 MicroVention Europe, S.A.R.L. PH +33 (1) 39 21 77 46 MicroVention Deutschland GmbH PH +49 211 210 798-0 microvention.com MICROVENTION, MicroPlex and HydroCoil are registered trademarks of MicroVention, Inc. • Refer to Instructions for Use, contraindications and warnings for additional information. Federal (USA) law restricts this device for sale by or on the order of a physician. ©2018 MicroVention, Inc. Jan. 2018 FLOW-DEPENDENT MICROCATHETER MAGIC catheters are designed for general intravascular use. They may be used for the controlled, selective regional infusion of therapeutic agents or embolic materials into vessels.1 1. Magic Catheters IFU – Ind 19 MKTG-068 Rev. A 18 Technology Drive #169, Irvine Ca 92618 P 949.788.1443 | F 949.788.1444 A Company Now you have 24 hours to make a lifetime of difference in stroke patients like Nora The Trevo Retriever is the only device cleared to reduce disability in stroke patients up to 24 hours from time last seen well. For more information, visit strykerneurovascular.com/trevo24hours Copyright © 2018 Stryker AP002078 v1.0 AXS Infinity LS™ Plus Long Sheath RX ONLY WARNINGS DEVICE DESCRIPTION Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is See package insert for complete indications, contraindications, warnings damaged. If damage is found, call your Stryker representative. and instructions for use. The AXS Vecta Aspiration System consists of the AXS Vecta 71 Aspiration Catheter, the Aspiration Tubing Set, and the VC 701 Cliq Aspirator Pump. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may INDICATIONS FOR USE compromise the structural integrity of the device and/or lead to device failure which, in turn, may The AXS Vecta 71 Aspiration Catheter is a single lumen, flexible, variable stiffness catheter. It has result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 71 of contamination of the device and/or cause patient infection or cross-infection, including, but not the peripheral, coronary, and neuro vasculature. Aspiration Catheter shaft has a lubricious coating at the distal end to reduce friction during use. limited to, the transmission of infectious disease(s) from one patient to another. Contamination of RX ONLY The Scout Introducer may be used in conjunction with the AXS Vecta 71 Aspiration Catheter to the device may lead to injury, illness or death of the patient. facilitate in the introduction of the AXS Vecta 71 Aspiration Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious coating at the distal end to After use, dispose of product and packaging in accordance with hospital, administrative and/or CONTRAINDICATIONS local government policy. There are no known contraindications. reduce friction during use. The inner lumen of the AXS Vecta 71 Aspiration Catheters is compatible with the Scout Introducer, guide wires and micro catheters. The inner lumen of the Scout Introducer 1. The AXS Vecta 71 Aspiration Catheter has not been evaluated for more than one (1) clot POTENTIAL ADVERSE EVENTS is compatible with guide wires and micro catheters of an outer diameter of less than 0.044in. retrieval attempt. • Acute vessel occlusion Each package includes one AXS Vecta 71 Aspiration Catheter, one Scout Introducer, one 2. The AXS Vecta 71 Aspiration Catheter was evaluated for an average duration of direct • Air embolism hemostasis valve, and two peel-away introducers. Dimensions of the AXS Vecta 71 Aspiration aspiration of 4 minutes. • Death Catheter and Scout Introducer are included on the individual device label. The AXS Vecta 71 3. This product is intended for single use only, do not re-sterilize or reuse. Re-sterilization and/or Aspiration Catheters are available in 3 different lengths, the device configurations including the reuse may result in cross contamination and/or reduced performance. • Distal embolization length of the Scout packaged with each catheter and the recommended microcatheter length is 4. When the catheter is exposed to the vascular system, it should be manipulated while under • Emboli presented in the table below. high-quality fluoroscopic observation. Do not advance or retract the catheter if resistance is • False aneurysm formation met during manipulation; determine the cause of the resistance before proceeding. • Hematoma or hemorrhage at the puncture site INC-11129- INC-11129- INC-11129- 5. Operators should take all necessary precautions to limit x-radiation doses to patients and Catheter part number • Infection 115 125 132 themselves by using sufficient shielding, reducing fluoroscopy times, and modifying x-ray • Intracranial hemorrhage technical factors where possible. Catheter inner diameter (in) 0.071 0.071 0.071 • Ischemia Distal catheter outer diameter (in) 0.082 0.082 0.082 PRECAUTIONS • Neurological deficit including stroke Catheter working length (cm) 115 125 132 1. Store in a cool, dry, dark place. • Vessel spasm, thrombosis, dissection or perforation Scout Introducer length (cm) 133 143 150 2. Do not use kinked, damaged, or opened devices. Recommended compatible 3. Use the device prior to the “Use By” date specified on the package. WARNINGS 150 160 160 Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is microcatheter length (cm) 4. Exposure to temperatures above 54°C (130°F) may damage device. Do not autoclave. Recommended compatible damaged. If damage is found, call your Stryker Neurovascular representative. 0.044 max 0.044 max 0.044 max 5. Torqueing or moving the device against resistance may result in damage to the vessel or For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may microcatheter outer diameter (in) device. Recommended compatible guidewire compromise the structural integrity of the device and/or lead to device failure which, in turn, may 0.038 max 0.038 max 0.038 max 6. Maintain a constant infusion of appropriate flush solution. result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk outer diameter (in) 7. If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. of contamination of the device and/or cause patient infection or cross-infection, including, but not Remove and replace the device. limited to, the transmission of infectious disease(s) from one patient to another. Contamination of The AXS Vecta Aspiration System is recommended for use in the following vessel size ranges
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