Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. The Solitaire X Revascularization Device is not to be used after the expiration date imprinted on the product label. 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. We performed the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME) trial to establish the efficacy and safety of rapid neurovascular thrombectomy. B. 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. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomized trials. Lancet Neurol. WhichMedicalDevice is a FREE resource created by clinicians for clinicians. For access to the full library of product manuals, visit the Medtronic Manual Library. The device is a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. If excessive resistance is encountered during the delivery of the Solitaire X Revascularization Device, discontinue the delivery and identify the cause of the resistance. Stroke. 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. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. TR-NV13807A, TR-NV15666A, D00419703A, D00324045A. A real-world observational study found that EVT may be safe and effective in patients with wake-up stroke and late-presenting stroke selected using . 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. The safety and efficacy of the Xact Carotid Stent System has not been demonstrated with embolic protection systems other than the Emboshield Embolic Protection System. As recently as 10 years ago, the package inserts of many stents, especially uncovered coronary stents, carried a warning not to scan patients in the first 6 weeks unless absolutely necessary. Home Pereira VM, Gralla J, Davalos A, et al. Read our cookie policy to learn more including how you may change your settings. 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. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Saver JL, Goyal M, Bonafe A, et al. Registration is quick and free. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. Read MR Safety Disclaimer Before Proceeding. Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. Solitaire X Revascularization Device does not allow for electrolytic detachment. J. Med. 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. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. Avoid unnecessary handling, which may kink or damage the Delivery System. Bench testing may not be representative of actual clinical performance. Lancet. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Case report: 63 year old female present pulsatile headache, diplopia, III. Solitaire X is a new generation revascularisation device with a unique parametric design, featuring an overlapping technology, providing physicians with improved delivery performance, effective clot retention and faster flow restoration timelines, designed to be deployed with a lower microcatheter profile, to provide expanded ease of delivery. Few data are available for comparing the therapeutic effects associated with the two mechanical thrombectomy techniques in acute ischemic stroke with atrial fibrillation. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. 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. Or information on our products and solutions? It is delivered through a standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. 2016; 15: 113847. 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. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Less information (see less). This site uses cookies to store information on your computer. J. Med. If you consent, analytics cookies will also be used to improve your user experience. Campbell BC, Hill MD, Rubiera M, et al. J. Med. Patients with known hypersensitivity to nickel-titanium. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com Healthcare Professionals Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. RESULTS: All except two types of stents showed minimal ferromagnetism. A total of 19 patients having under-gone intracranial stenting for aneurysms were imaged by MRI at 1.5T. The tables show the Gore devices that are labeled as MR conditional. The permanent stent acts like a scaffold for the artery. &dR~% '7) W P2yob)eRUX@F&oE+7" % Cardiovasc Interv. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 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! 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. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . 4 0 obj Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. For best results, use Adobe Reader to view Medtronic manuals. Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. Solitaire X The information on this page is current as of November 2022. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. 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. NOTE: A patient may have more than one implanted 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 . Click OK to confirm you are a Healthcare Professional. See our stroke products, from stent retrievers to aspiration systems. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. Use of the Solitaire X Revascularization Device is contraindicated under these circumstances. nial stents and to assess the utility of performing gadolin-ium-enhanced MRA. The purpose of this study was to . NV AIS Solitaire X Animation Circ Our aim was to evaluate the safety and efficacy of the long Solitaire 4 40 mm stent retriever for large vessel occlusion in stroke patients. Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. 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). Some controversies regarding the safety of the technique were introduced by the recent publication of . per pulse sequence). With an updated browser, you will have a better Medtronic website experience. Garca-Tornel , Requena M, Rubiera M, et al. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. Contact Medtronic | Terms of Use | Privacy Statement | Medtronic Manual Library | Choose Region, (such as 9528, 3875-45, 305U219, ENSP30030W), (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim), (such as pacemaker, stent, otology implants, drug pump), All conditions for use for all implanted devices, The associated risks for a patient with these devices. Subscribe to our newsletter. Medical Information Search Thrombectomy within 8 hours after symptom onset in ischemic stroke. The idea was that the stent needed time to "settle in" and become incorporated in the vessel wall before risking displacement by magnetic forces. F= Z1SWb-h{1-9mJqc52u[(Mk[){g~,YJmnixZq:aNPWj/N4j Do you need support for procedures? 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. 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. Jun 11 2015;372(24):2285-2295. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. 15 minutes of scanning (i.e. How about other GU devices like nephrostomy tubes and stents? The risk of clot migration into arteries downstream during the procedure is also a concern, as it may complicate reperfusion and increase the possibility of neurological impairment.11-13 The regimen for isolated ICA with EVT is ambiguous, and the therapeutic efficacy needs further examination. Our aim was to assess the feasibility and safety of permanent stent placement with the Solitaire FR compared with other self-expanding stents for intracranial artery recanalization for acute ischemic stroke. 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. 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. N. Engl. Do not use if the package is open or damaged. Please help keep this site free for everyone in the world! Is it safe to have MRI with heart stents? Indications, Safety, and Warnings. Stroke. Date of coronary stent placement and device manufacturer should be documented prior to MRI. 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. . Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. Randomized trials of mechanical thrombectomy (MT) generally exclude patients over the age of 80 years with baseline disability. 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. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. MR:comp is the leading company for MR safety and MR compatibility testing of implants, instruments and medical devices. stent dislodgment soon after left main coronary artery stenting. Umansky F, Juarez SM, Dujovny M, et al. Mar 12 2015;372(11):1019-1030. When to Stop [published correction appears in Stroke. For device safety, do not use each Solitaire X Revascularization Device for more than three flow restoration recoveries. Methods Between January 2015 and April 2017, 96 . 2020 Jun;51(6):e118]. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. 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). 2022;53(2):e30-e32. Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. Download the latest version, at no charge. We do not make your details available to any third parties nor do we send unsolicited emails to our members. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. The patient's wallet card specifies the model number. A randomized trial of intraarterial treatment for acute ischemic stroke. Maximum 15 min of scanning (per sequence). 4 W/kg (first level controlled operating mode), 15 minutes of scanning (i.e., per pulse sequence), In non-clinical testing, the image artifact caused by the GORE, In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the GORE, Immediately after placement if conditions are met, 10 mm relative to the size and shape of the vascular device, 60 minutes of continuous RF (a sequence or back to back series/scan without breaks). Medtronic Data on File. Usable length that is at least as long as the length of the thrombus. Do not reprocess or re-sterilize. This stent can be safely scanned in an MR system meeting the following . Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. Your opinion matters to others - rate this device or add a comment. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. With an updated browser, you will have a better Medtronic website experience. Healthcare Professionals Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. Use of appropriate anticoagulant and/or antiplatelet therapy per standard of care is recommended for use with this stent system. The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). Learn more about navigating our updated article layout. The best of both worlds: Combination therapy for ischemic stroke. Under these conditions, the central portion of the lumen of the aortic component was visible. For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size. Indications, Safety and Warnings IFU Bench and animal testing may not be representative of actual clinical performance. Endovascular therapy with the device should be started within 6 hours of symptom onset. Frequent questions. Do not torque the Solitaire X Revascularization Device. - (00:00), NV AIS Solitaire X Animation Recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke. Did you know you can Register for FREE with this website? 2017;48(10):2760-2768. The presence of this implant may produce an image artifact. N. Engl. N. Engl. Oct 2013;44(10):2802-2807. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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. It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Stroke. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. 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 |! Do not use kinked or damaged components. The longterm efficacy of this technique may be improved by increasing the packing density around the aneurysmal neck and improving the hemodynamics. 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. 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). The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. % The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. Based on bench testing results. Stroke. More information (see more) Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. N. Engl. Is there an increased risk of IVC filters moving during MRI? Neurological A stent crimping technology, which provides excellent stent retention and provides smooth surface transition across the stent and delivery system. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. Safety of magnetic resonance imaging in patients with cardiovascular devices: An American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: Endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance, MRI safety and devices: an update and expert consensus, Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation, Metallic stents: Evaluation of MR imaging, Long-term safety of cardiac magnetic resonance imaging performed in the first few days after bare-metal stent implantation. Some cookies are strictly necessary to allow this site to function. Serge Bracard, Xavier Ducrocq, et al. Do not advance the microcatheter against any resistance. Includes Solitaire FR, Solitaire 2. . > J. Med. Stents are basically small tubes or sometimes springs that help prop arteries open. Stroke. Apr 23 2016;387(10029):1723-1731. The distinctive, evenly-spaced platinum markers let you visualise the optimal working length and stent behavior for real-time procedural feedback, ensuring accurate alignment, optimal revascularisation, and clot capture success.2, The 6x40 length device simplifies placement with proximal ophthalmic alignment, providing complete visualisation and coverage from M2 to ICA.4,6, Our SolitaireTM portfolio is backed by published data with 11+ trials and case studies worldwide, proving it reduces stroke-related disability in patients suffering a large vessel acute ischemic stroke following IV t-PA.9-19. This device is supplied STERILE for single use only. Microsurgical anatomy of the proximal segments of the middle cerebral artery. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. 2014;45:141-145. In addition to conventional T2- and diffusion-weighted MRI, 3D time-of-ight MRA was performed before and after !mqHfALY48 cexRM_ #6O{'_SAK5sUHGOnX-6Aw !664W@q '#qJi&qI Vascular AIS Revascularization Products If you continue, you may go to a site run by someone else. Goyal M, Demchuk AM, Menon BK, et al. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. treatment of ischemic stroke among patients with occlusion. Find out more Keep up to date

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