per pulse sequence). Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, The distinctive, evenly spaced platinum markers enable, Maintains consistent cell size and structure over varying vessel diameters, Provides multiple planes of contact to integrate with the clot, even double layering in smaller vessels, Meaningful visibility with real-time visualization of the radiopaque markers, Evaluate clot composition through body marker integration into the clot, Visualize the expansion and compression of the stent to help. The "conditions" associated with some stents recommend that whole-body-averaged SAR levels not exceed 2 W/kg and a maximum of 15 minutes per sequences, while other stents permit up to 4 W/kg. x]6}WjX|}Y<0<4dHwOgb-KV,R%>??(VjqX\.?6Zg3?yQU;CmS6T(o^vYzC5'!ucXSYk$'Ai]SFoO9m4U4]_5-C.6m5E@eTTy\KyG*=gXN| F1t)O}]}(?Z~_,-wky}7 )}-p}y-[JE'!+"{Q%iRMVqITPh>X~F\H[WDD |! Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. Or information on our products and solutions? N. Engl. Case report: 63 year old female present pulsatile headache, diplopia, III. For each new Solitaire X Revascularization Device, use a new microcatheter. Lancet Neurol. Do not treat patients with known stenosis proximal to the thrombus site. For a full version of conditions, please see product Instructions for Use (IFU). Do you need support for procedures? Solitaire AB Neurovascular Remodeling Deviceis designed for thetreatment of intracranial neurovascular disease. Bolstered by the integration of a historic $50 billion acquisition, Medtronic garnered $28.8 billion in fiscal 2016 sales to surpass rival Johnson & Johnson for top industry billing and bragging rights. The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. ?\IY6u_lBP#T"42%J`_X MUOd Solitaire X. Bench testing may not be representative of actual clinical performance. This device is supplied STERILE for single use only. Microsurgical anatomy of the proximal segments of the middle cerebral artery. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. The presence of this implant may produce an image artifact. Home Stroke. Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. Some controversies regarding the safety of the technique were introduced by the recent publication of . Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. 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. The patient's wallet card specifies the model number. 4 0 obj A randomized trial of intraarterial treatment for acute ischemic stroke. The drug is slowly released to help keep the blood vessel from narrowing again. Less information (see less), Images courtesy of Dr. Alejandro Tomasello Weitz, Differentiated radial outward force promotes clot and vessel wall contact during retrieval with the optimal amount of radial force.10*, A large real-world patient cohort demonstrated a first pass effect (FPE) rate of 40.5% and a modified FPE (mFPE) rate of 58.9% across patients treated with the Solitaire device.14, A large real-world patient cohort demonstrated the following results with the Solitaire device.15, modified Rankin Scale (mRS) 02 at 90days, Symptomatic intercranial hemorrhage (sICH). GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short WireBiliary Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft, GORE TAG Thoracic Branch Endoprosthesis, GORE EXCLUDER Conformable AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis, GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis, GORE VIATORR TIPS Endoprosthesis/GORE VIATORR TIPS Endoprosthesis with Controlled Expansion. 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. Most heart valves and coronary artery stents currently on the market and implanted in patients can go safely through an MRI scanner, Dr. Flamm says. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Randomized assessment of rapid endovascular treatment of ischemic stroke. Reasons for Reperfusion Failures in Stent-Retriever-Based Thrombectomy: Registry Analysis and Proposal of a Classification System For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. This site is Exclusively Sponsored by BRACCO, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices, Cardiovascular Catheters, Other Catheters, and Accessories. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. If excessive resistance is encountered during the delivery of the Solitaire X Revascularization Device, discontinue the delivery and identify the cause of the resistance. The Solitaire AB stent is a scaffold that do flow blood diversion and promotes the aneurysms exclusion by thrombosis. Learn more about navigating our updated article layout. If you continue, you may go to a site run by someone else. The Solitaire X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). What do you do about tracheobronchial airway devices like stents, valves and coils. Tomasello A. Non-clinical testing has demonstrated that the Xact Carotid stent is MR Conditional. Based on smallest vessel diameter at thrombus site. Healthcare Professionals %PDF-1.3 This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. Zaidat OO, Castonguay AC, Linfante I, et al. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. With an updated browser, you will have a better Medtronic website experience. AIS Revascularization Products Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. Stroke. stream Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy Please Enter the Model Number or Select the Valid Model Number From the List, Please Enter the Product Name or Select the Valid Product Name From the List. 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging Approach for Acute Endovascular Therapy - Read online for free. For best results, use Adobe Reader to view Medtronic manuals. Categorised under: Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device. Avoid unnecessary handling, which may kink or damage the Delivery System. Bench and animal testing may not be representative of actual clinical performance. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Based on bench testing results. It is possible that some of the products on the other site are not approved in your region or country. 2018;49(10):2523-2525. 2016; 15: 113847. Interventional Radiology We've kept the same highly effective Trevo stent, designed to reduce disability in patients experiencing acute ischemic stroke (AIS) up to 24 hours from time last seen well by removing clots to . Possible complications include, but are not limited to the following: Disclaimer: This page may include information about products that may not be available in your region or country. Carry the Patient Implant Card with you at all times and show it to any medical professional who treats you. Drug-coated stents have been approved for use by the U.S. Food and Drug Administration (FDA). WhichMedicalDevice is a FREE resource created by clinicians for clinicians. The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. Less information (see less). Solo MicroPumpInsulin PumpMedingo US, Inc.www.Medingo.com, Solo Smart Heart Valve ProsthesisSorin Group, www.sorin.com, Solo Tympanostomy Tube Device Ventilation Tube Otologic implant High Density Polyethylene (HDPE) AventaMed,www.aventamed.com, Solo+ Tympanostomy Tube Device (TTD) Ventilation Tube, Solus Anterior Lumbar Interbody Fusion (ALIF)Alphatec Spine Inc., www.alphatecspine.com, Solus Double Pigtail StentCook Medical, Inc.www.cookmedical.com, Solyx SIS(Single Incision Sling) SystemBoston Scientific CorporationMarlborough, MA, SOPH-A-PORT Mini Spinal Implantable Access PortSophysa, www.sophysa.com, SOPHY Adjustable Pressure Valve Sophysa USA, Inc. www.sophysa.com, Sophy programmable pressure valveModel SM8misc.SophysaOrsay, France, Sophy programmable pressure valveModel SM8SophysaOrsay, France, Sophy programmable pressure valveModel SP3misc.SophysaOrsay, France, Sophy programmable pressure valveModel SU8SophysaOrsay, France, Sophysa SOPH-A-PORT Mini SImplantable Access PortShire, www.shire.com, Soprano Armonia Heart Valve ProsthesisSorin Group, www.sorin.com, Sorin Allcarbon, ASModel MTR-29AS, 29 mmpyrolitic carbonHeart ValveSorin Biomedica Cardio S.p.A.Saluggia, Italy. Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. Products Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. J. Med. With an updated browser, you will have a better Medtronic website experience. Visi-pro balloon expandable vascular and biliary stent, SUPERA Veritas Self-Expanding Nitinol Stent, Maris Deep Infrapopliteal Self-Expanding Stent, Chromis Deep Infrapopliteal Balloon-Expandable Stent, Tsunami Peripheral Balloon-expandable Stent, Continuous Renal Replacement Therapy (CRRT), Percutaneous Ventricular Restoration Therapy. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The Solitaire X Revascularization Device is not to be used after the expiration date imprinted on the product label. by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: > Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. N. Engl. Do not reprocess or re-sterilize. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Failure to comply with the conditions for use can cause damage to the implanted devices or serious injury to the patient, including death. The information on this page is current as of November 2022. You just clicked a link to go to another website. The Solitaire X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Thrombectomy within 8 hours after symptom onset in ischemic stroke. Solitaire X Revascularization Device does not allow for electrolytic detachment. 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. Oral presentation at: International Stroke Conference; February 9, 2022; New Orleans, LA. The best of both worlds: Combination therapy for ischemic stroke. The hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). 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. Read MR Safety Disclaimer Before Proceeding. See Table XXI in online Data Supplement 1 Downloaded from httpahajournalsorg by from MNGMT 123 at University of Virginia For device safety, do not use each Solitaire X Revascularization Device for more than three flow restoration recoveries. B. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. 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. using stent-retrievers has been proven to be a safe and effective treatment in acute ischemic stroke (AIS . Cardiac stents are small, metal mesh tubes that are inserted into narrowed or blocked coronary arteries to improve blood flow to the heart. Read our cookie policy to learn more including how you may change your settings. Your use of the other site is subject to the terms of use and privacy statement on that site. Circ MRI Information. As there are no known coronary stents made from ferromagnetic metallic materials, it is not necessary to wait 6 weeks or longer for MRI scanning. Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset (IV t-PA use beyond 3 hours is not approved in the United States). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Campbell BC, Mitchell PJ, Kleinig TJ, et al. Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. Metabolic encephalophaties are by definition those disorder of the central nervous system that are not due primarily to structural abnormalities . 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. The powerful magnetic field of the MRI scanner may damage internal metal devices, such as a heart pacemaker. Jan 1 2015;372(1):11-20. 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. Cardiovasc Interv. Stents (non covered ). The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. The overlapping stent design allows the device to expand in larger vessels and compress in smaller vessels during deployment and retrieval3 as well as: Our Solitaire X revascularisation device - designed with an optimised delivery system - produces lower delivery force7 for improved procedural efficiency and smooth navigation through even the most complicated anatomy. Conclusion The Solitaire stent was initially developed for the endovascular treatment of wide necked intracranial aneurysms but has been demonstrated to be safe and efficacious for intracranial thrombectomy. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. Read robust data about the safety and efficacy of the Solitaire revascularization device. Garca-Tornel , Requena M, Rubiera M, et al.

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