A. zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI Reports from device programmers include references to the model number: Product Name search includes brand or trademark names for many Medtronic products; however, not all products are included. Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. Indications, Safety and Warnings IFU 2017;48(10):2760-2768. Oct 2013;44(10):2802-2807. Products Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. J. Med. Do not torque the Solitaire X Revascularization Device. This was the first successful human clinical use of a Solitaire stent for this purpose and the ignition spark for the development of a whole generation of new devices, now called stent . Stents are basically small tubes or sometimes springs that help prop arteries open. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. N. Engl. stent dislodgment soon after left main coronary artery stenting. - (00:00), NV AIS Solitaire X Animation Stents (non covered ). Trevo NXT | Stryker Reperfusion Treatments in Disabling Versus Nondisabling Mild Stroke due Stroke. The device is a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. #vDq2wXbO/D"Od_n00|IV+iZ7D{?Q`8'D1[1^-_S=8rTWZw5SD@n&M66;,AU5 7b ; a+;VAC=` "340pfgv~y?/SOU8dt)&k,S^_*5DSn}(N YVbwcKxNIL|.h~v%Wv-?.\qd wMF{AgeBU*^x@OqVnET.I|a,vv0gF38lN2J}A. The Solitaire X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. TN Nguyen & Al. Neurological 2018;49(10):2523-2525. The powerful magnetic field of the MRI scanner may damage internal metal devices, such as a heart pacemaker. Methods Between January 2015 and April 2017, 96 . We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Please consult the approved indications for use. It is possible that some of the products on the other site are not approved in your region or country. Or information on our products and solutions? Do not cause delays in this therapy. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. The Solitaire X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. NV AIS Solitaire X Animation Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. Campbell BC, Mitchell PJ, Kleinig TJ, et al. Stents are widely used throughout the entire arterial system, ranging from vessels several centimeters across (like the thoracic aorta) down to vessels only a few millimeters in diameter (like coronary and intracranial arteries). A comprehensive portfolio for all AIS techniques. Solitaire X. Saver JL, Goyal M, Bonafe A, et al. Jadhav AP, Desai SM, Zaidat OO, et al. The MRI safety information is given on the Patient Implant Card. :: Journal of Stroke For a compatible microcatheter to help you smoothly navigate through even the most complicated anatomy, choose from the Phenom 21 or 27 catheter to deliver the Solitaire X device. Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. Medtronic Data on File. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. Is there an increased risk of IVC filters moving during MRI? Maximum 15 min of scanning (per sequence). Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. The information on this page provides only a summary of MR conditions for each device and is intended as a reference for the U.S. only. WhichMedicalDevice is a FREE resource created by clinicians for clinicians. The information on this page is current as of November 2022. Methods: Solitaire AB stents were placed during angioplasty and stenting of MCA and BA stenoses in patients at our department between January 2015 and May 2017 with 6-36 months follow-up. Jun 11 2015;372(24):2285-2295. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Indications, Safety and Warnings - Boston Scientific If excessive resistance is encountered during recovery of the Solitaire X Revascularization Device, discontinue the recovery and identify the cause of the resistance. . Do not recover (i.e. %PDF-1.3 2022 The Regents of the University of California | Accessibility | Terms of Use | Privacy Policy, (T32) Biomedical Imaging for Clinician Scientists. The safety of MRI within 24 hours of stent implantation has not been formally studied. Solitaire AB stent-angioplasty for stenoses in perforator rich segments Stroke. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. Do you need support for procedures? Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Based on smallest vessel diameter at thrombus site. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Medical Information Search Stroke. Open-cell stent and use of cone-beam CT enables a safe and effective coil embolization of true ophthalmic artery and anterior choroidal artery aneurysms with preservation of parent vessel: Clinical and angiographic results - PMC The new PMC design is here! Stroke. 1. Medtronic plc : Top Global Medical Device Companies in 2017 Brand Name: Solitaire X Version or Model: SFR4-3-20-10 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: Micro Therapeutics, Inc. Primary DI Number: 00763000367619 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 826110710 * Terms of Use 1,2 The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. Bench and animal testing may not be representative of actual clinical performance. ObjectivesThe stent retriever thrombectomy (SRT) and a direct aspiration first-pass technique (ADAPT) are the two main mechanical thrombectomy (MT) techniques for acute ischemic stroke. Drug-coated stents have been approved for use by the U.S. Food and Drug Administration (FDA). Intracranial Aneurysm Stenting: Follow-Up With MR Angiography The presence of this implant may produce an image artifact. How about other GU devices like nephrostomy tubes and stents? To be fair and balanced, there is a single controversial case report from 2013 (Parthasarathy H, Saeed O, Marcuzzi D, Cheema AN. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. MR:comp GmbH | MR Safety and Compatibility Testing - MR:comp GmbH Based on bench testing results. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. 15 minutes of scanning (i.e. Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Patients with angiographic evidence of carotid dissection. The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. The drug is slowly released to help keep the blood vessel from narrowing again. For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size. Thrombectomy within 8 hours after symptom onset in ischemic stroke. This library contains technical information on whether an MRI scan can be performed and how to perform a scan on patients with Medtronic implantable devices. Xact Carotid Stent System | Abbott The XIENCE V stent should not migrate in this MRI environment. Berkhemer OA, Fransen PS, Beumer D, et al. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 Solitaire AB stent (6 mm 30 mm) assisting complete occlusion in one This site uses cookies to store information on your computer. Open-cell stent and use of cone-beam CT enables a safe and effective per pulse sequence). RX Only. (17) Sommer T, et al. THE List - mrisafety.com MR Safety and Imaging of Neuroform Stents at 3T Microsurgical anatomy of the proximal segments of the middle cerebral artery. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device. Click OK to confirm you are a Healthcare Professional. Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. Do not advance the microcatheter against any resistance. For best results, use Adobe Reader to view Medtronic manuals. Vascular Mar 12 2015;372(11):1019-1030. CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Solitaire X Revascularization Device does not allow for electrolytic detachment. Solitaire X - AIS Revascularization Products | Medtronic The hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). stream For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. The idea was that the stent needed time to "settle in" and become incorporated in the vessel wall before risking displacement by magnetic forces. Products Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. Campbell BC, Hill MD, Rubiera M, et al. B. 2019;50(7):1781-1788. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. Based on bench and animal testing results. The size of imaging artifacts was measured with all the stents under standardized conditions and with six stents after their implantation into the coronary arteries of freshly explanted pig hearts. Biliary stents MRI safety - All your info about health and medicine Usable length that is at least as long as the length of the thrombus. using stent-retrievers has been proven to be a safe and effective treatment in acute ischemic stroke (AIS . Why Does Mechanical Thrombectomy in Large Vessel Occlusion Sometimes Since that time, several papers have been published demonstrating the safety of scanning patients immediately after stent placement; so that is the protocol I follow and recommend. Includes Solitaire FR, Solitaire 2. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . TR-NV13807A, TR-NV15666A, D00419703A, D00324045A. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. Registration gives you full access to all of the features of WhichMedicalDevice. You just clicked a link to go to another website. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com Zaidat OO, Castonguay AC, Linfante I, et al. When the GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface was placed within a bare nitinol stent the image artifact extended up to 20 mm from the devices. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. A total of 19 patients having under-gone intracranial stenting for aneurysms were imaged by MRI at 1.5T. Recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke. Some cookies are strictly necessary to allow this site to function. The Orsiro Mission stent is MR conditional. The longterm efficacy of this technique may be improved by increasing the packing density around the aneurysmal neck and improving the hemodynamics. Carry the Patient Implant Card with you at all times and show it to any medical professional who treats you. 2020 Jun;51(6):e118]. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. The Solitaire X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Solitaire X Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. !mqHfALY48 cexRM_ #6O{'_SAK5sUHGOnX-6Aw !664W@q '#qJi&qI The permanent stent acts like a scaffold for the artery. Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled Few data are available for comparing the therapeutic effects associated with the two mechanical thrombectomy techniques in acute ischemic stroke with atrial fibrillation. Although the authors blamed the MRI for the displacement, subsequent letters to the editor cast doubt on this assertion, providing evidence that the original stent was poorly chosen and placed and that spontaneous displacement of similarly placed stents had been reported in the absence of MRI. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging If you consent, analytics cookies will also be used to improve your user experience. MRI Information. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. It is generally safe to undergo magnetic resonance imaging (MRI) scans with stents in place, though a lot of this depends on when the stent was implanted and what, exactly, it is intended to do. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. Please help keep this site free for everyone in the world! The safety and effectiveness has not been established for the Solitaire X device to reduce disability in patients with the following: More distal occlusions in the anterior circulation. No device migration or heating was induced. "MR Conditional" stent graft treating a thoracic aneurysm (Courtesy Cook), To my knowledge, there are no currently implanted stents that are considered. Judicious selection of patients is necessary, since the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events. Stroke. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. Tomasello A. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Update my browser now. See our stroke products, from stent retrievers to aspiration systems. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. Date of coronary stent placement and device manufacturer should be documented prior to MRI. Flottmann F, Leischner H, Broocks G, et al. Solitaire AB Neurovascular Remodeling Deviceis designed for thetreatment of intracranial neurovascular disease. Categorised under: Medtronic MRI Resource Library: Home This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices, Ocular Implants, Lens Implants, and Devices, Cardiovascular Catheters, Other Catheters, and Accessories, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories. Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. The purpose of this study was to . The patient's wallet card specifies the model number. Slot Screwdriver3*50-mmNewmatic Medical, www.newmaticmedical.com, Small External FixatorExternal Fixation Systemcarbon composite, Titanium alloy, aluminum, SSBiomet, Inc., www.biomet.com, Small External FixatorExternal Fixation SystemDepuy Synthes, www.depuysynthes.com, SMart De La Cruz PistonOtologic ImplantNitinol/FluoroplasticGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, SMart Malleus PistonOtologic ImplantNitinol/FluoroplasticGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, SMart PistonOtologic ImplantFluoroplastic/NitinolGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, Smart Port CT-Injectable Portvascular access portAngioDynamicswww.angiodynamics.com, Smart Port(s), Vascular Access PortAngiodynamics, Inc., www.Angiodynamics.com, SmartGuide CT/MRIMRI Devices CorporationWaukesha, WI, Smelloff CutterAortictitaniumheart valveSorin BiomedicaItaly, Smeloff-CutterHeart ValveCutter Laboratories, Berkeley, CA, Snowshoe Suture Anchor PairUSGI Medical, Inc., www.usgimedical.com, Socket Preservation ScrewMedtronic, www.medtronic.com, Sof-Curl Ureteral StentPolyurethaneGyrus ACMI, Inc.Maple Grove, M, Soft Lift Treatment of Urinary Stress IncontinenceCousin Biotech, www.cousin-biotech.com, Soft Tissue Biopsy Needle Gun & biopsy needle (304 SS)Anchor Procducts Co.Addison, IL, Solanas Posterior Cervico-Thoracic Fixation SystemAlphatec Spine Inc., www.alphatecspine.com, Solex Intravascular Heat Exchange Catheter (Model SL-2593/8700-0671-01)Zoll Circulation, www.zoll.com, SOLITAIRE AB Neurovascular Remodeling DeviceCovidien and ev3 Inc., www.ev3.net, Solitaire Flow Restoration StentNitinol, SS, PlatinumCovidien and ev3 Inc., www.ev3.net. _+'$@K8)Z3M2m#rb^U>K%J]}m?lu*au&lm1Kf!J/ hiTqpCJY9[HB5=m]d5X|h ^C`h8malAb :wiN. > . Mar 12 2015;372(11):1009-1018. Some controversies regarding the safety of the technique were introduced by the recent publication of . Endovascular treatment for acute ischaemic stroke caused by isolated J. Med. Artifacts extended both inside and outside the device lumen. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. Methods We conducted a retrospective analysis of all patients treated for acute ischemic large vessel occlusion stroke with the Solitaire 2 FR 4 40 device between May . Please consult the approved indications for use. Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis.