Complete Issue (PDF)

Complete Issue (PDF)

JUNE 2018 AJNR VOLUME 39 • PP 993–1191 JUNE 2018 THE JOURNAL OF DIAGNOSTIC AND VOLUME 39 INTERVENTIONAL NEURORADIOLOGY NUMBER 6 WWW.AJNR.ORG Multisite concordance of DSC for brain tumors Comparison of 3T intracranial vessel wall sequences Ophthalmic artery collaterals in Moyamoya disease Official Journal ASNR • ASFNR • ASHNR • ASPNR • ASSR Low-profile Visualized Intraluminal Support Stent Deployment. Refined. Braided Coil Assist Stents with High Neck Coverage, Excellent Visibility and Improved Conformability* Aneurysm Therapy Solutions For more information or a product demonstration, contact your local MicroVention representative: MicroVention Worldwide Innovation Center PH +1.714.247.8000 35 Enterprise *Humanitarian Device: Authorized by Federal Law for use with bare platinum Aliso Viejo, CA 92656 USA embolic coils for the treatment of unruptured, wide neck (neck ≥ 4 mm or dome to neck ratio < 2), intracranial, saccular aneurysms arising from a parent MicroVention UK Limited PH +44 (0) 191 258 6777 vessel with a diameter ≥ 2.5 mm and ≤ 4.5 mm. The effectiveness of this device MicroVention Europe, S.A.R.L. PH +33 (1) 39 21 77 46 for this use has not been demonstrated. MicroVention Deutschland GmbH PH +49 211 210 798-0 microvention.com MICROVENTION and LVIS 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 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 A Complete Coil Portfolio MicroVention’s comprehensive portfolio features clinically proven Aneurysm Hydrogel coils, which can be used exclusively or in combination Therapy with our trusted Platinum coils to treat a wide range of aneurysms Solutions and neurovascular lesions. Breakthrough Hydrogel Technology • Less Recurrence • Less Retreatment • More Progressive Occlusion Compared to platinum coils with comparable safety1 REFERENCES: 1. Taschner et al. Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysm; A Randomized Controlled Trial. 2018;49:00-00. DOI:10.1161/ STROKEAHA.117.018707 INDICATIONS FOR USE: The HydroCoil® Embolic System (HES) and MicroPlex® Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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. MicroVention Worldwide For more information or a product demonstration, Innovation Center PH +1.714.247.8000 contact your local MicroVention representative: 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 Bending expectations of conformability and stability. Enhanced conformability – The hybrid cell structure is designed to enhance stent opening and conformability in bifurcations and tight curves. Ease of use – All sizes of the Neuroform Atlas Stent are deliverable through Excelsior® SL-10 ® and Excelsior XT-17™ Microcatheters. Higher deployment accuracy – The Neuroform Atlas Stent is designed to have very low foreshortening, which enables very high deployment accuracy. The Neuroform Atlas Stent System is authorized under a Humanitarian Device Exemption (HDE). Copyright © 2017 Stryker IRB approval is required prior to use. AP001839 v1.0 | Page 1 of 2 Thank You ƚŽƚŚĞ^EZϱϲƚŚŶŶƵĂůDĞĞƟŶŐΘ dŚĞ&ŽƵŶĚĂƟŽŶŽĨƚŚĞ^EZ^LJŵƉŽƐŝƵŵϮϬϭϴ WĂƌƚŶĞƌƐ͗ ^ƵƐƚĂŝŶŝŶŐWĂƌƚŶĞƌ ŽůůĂďŽƌĂƟŶŐWĂƌƚŶĞƌƐ SAVE THE DATE 1 st Annual Meeting of the AMERICAN SOCIETY OF Pediatric Neuroradiology January 18-20, 2019 Royal Sonesta Hotel - New Orleans • New Orleans, Louisiana Please contact Educational Symposia, at 813-806-1000 or [email protected] or visit www.ASPNR.org for additional information. Neuroform Atlas™ Stent System • Standard interventional devices with distal tips > 1.8 F may not be able to • Discontinue use of microcatheter for infusion if increased resistance is to injury, illness or death of the patient. pass through the interstices of the stent. noted. Resistance indicates possible blockage. Remove and replace blocked • After use, dispose of product and packaging in accordance with hospital, See package insert for complete indications, contraindications, microcatheter immediately. DO NOT attempt to clear blockage by over- warnings and instructions for use. • Safety of the Neuroform Atlas Stent System in patients below the age of 18 administrative and/or local government policy. has not been established. pressurization. Doing so may cause the microcatheter to rupture, resulting in • These devices are intended for use only by physicians trained in Humanitarian Device. Authorized by Federal law for use with • In cases where multiple aneurysms are to be treated, start at the most vascular damage or patient injury. performing endovascular procedures. neurovascular embolic coils in patients who are ≥ 18 years of age for distal aneurysm first. • Do not exceed 2,070 kPa (300 psi) infusion pressure. Excessive pressure • Limited testing has been performed with solutions such as contrast the treatment of wide neck, intracranial, saccular aneurysms arising could dislodge a clot, causing thromboemboli, or could result in a ruptured from a parent vessel with a diameter of ≥ 2 mm and ≤ 4.5 mm that are MAGNETIC RESONANCE IMAGING (MRI) media, saline and suspended embolic particles. The use of these catheters microcatheter or severed tip, causing vessel injury. for delivery of solutions other than the types that have been tested for not amenable to treatment with surgical clipping. Wide neck aneurysms Safety Information Magnetic Resonance Conditional are defined as having a neck ≥ 4 mm or a dome-to-neck ratio < 2. The CAUTIONS / PRECAUTIONS compatibility is not recommended. Do not use with glue or glue mixtures. effectiveness of this device for this use has not been demonstrated. Non-clinical testing and analysis have demonstrated that the Neuroform Atlas • The accessories are not intended for use inside the human body. Stent is MR Conditional alone, or when overlapped with a second stent, and • To reduce the probability of coating damage in tortuous vasculature, use a guide catheter with a minimum internal diameter as specified in • Carefully inspect all devices prior to use. Verify shape, size and condition are INDICATIONS FOR USE adjacent to a Stryker Neurovascular coil mass. A patient with the Neuroform suitable for the specific procedure. ™ Atlas Stent can be safely scanned immediately after placement of this Table 1 above, and is recommended for use with Stryker Neurovascular The Neuroform Atlas Stent System is indicated for use with neurovascular hydrophilically coated microcatheters. • Exchange microcatheters frequently during lengthy procedures that require embolic coils in patients who are ≥ 18 years of age for the treatment of wide implant, under the following conditions: • To control the proper introduction, movement, positioning and removal of extensive guidewire manipulation or multiple guidewire exchanges. neck, intracranial, saccular aneurysms arising from a parent vessel with a • Static magnetic field of 1.5 and 3.0 Tesla the microcatheter within the vascular system, users should employ standard • Never advance or withdraw an intravascular device against resistance diameter of ≥ 2 mm and ≤ 4.5 mm that are not amenable to treatment with • Maximum spatial gradient field up to 2500 Gauss/cm (25 Tesla/m) clinical angiographic and fluoroscopic practices and techniques throughout until the cause of the resistance is determined by fluoroscopy. Movement surgical clipping. Wide neck aneurysms are defined as having a neck ≥ 4 mm • Maximum MR system reported whole body averaged specific absorption the interventional procedure. of the microcatheter or guidewire against resistance could dislodge a clot, or a dome-to-neck ratio of < 2. rate of 2 W/kg (Normal Operating Mode) and head averaged specific • Exercise care in handling of the microcatheter during a procedure to reduce perforate a vessel wall, or damage microcatheter and guidewire. In severe CONTRAINDICATIONS absorption rate of 3.2 W/kg. the possibility of accidental breakage, bending or kinking. cases, tip separation of the microcatheter or guidewire may occur. Under the scan conditions defined above, the Neuroform Atlas Stent is Patients in whom antiplatelet and/or anticoagulation therapy is • Use the product prior to the “Use By” date printed on the label. • Inspect

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