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. Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. If excessive resistance is encountered during recovery of the Solitaire X Revascularization Device, discontinue the recovery and identify the cause of the resistance. Campbell BC, Mitchell PJ, Kleinig TJ, et al. Bench and animal testing may not be representative of actual clinical performance. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus related topics: Ischemic Stroke U.S. FDA Resources Arms and Interventions Go to Outcome Measures Go to Avoid unnecessary handling, which may kink or damage the Delivery System. Goyal M, Demchuk AM, Menon BK, et al. > When to Stop [published correction appears in Stroke. 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. The purpose of this study was to . Do not treat patients with known stenosis proximal to the thrombus site. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. In addition to conventional T2- and diffusion-weighted MRI, 3D time-of-ight MRA was performed before and after The best of both worlds: Combination therapy for ischemic stroke. The hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. Use of the Solitaire X Revascularization Device is contraindicated under these circumstances. Flottmann F, Leischner H, Broocks G, et al. It was a crowning achievement, as transformative for the company as it was impressive in both size and scope. 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. The aim of this procedure is to ensure that a stent is in the correct place and that it is not blocking the drainage of bile. Based on bench testing results. Our team is happy to help answer any questions you may have. 2018;49(3):660-666. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. First pass effect with neurothrombectomy for acute ischemic stroke: Analysis of the systematic evaluation of patients treated with stroke devices for acute ischemic stroke registry. Lancet Neurol. 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. 5.2 (MISE JOUR DE 2022) Administration de la thrombolyse intraveineuse La thrombolyse intraveineuse doit tre offerte tous les patients ayant subi un AVC ischmique invalidant qui sont admissibles l'altplase ou la tnectplase dans les 4,5 heures suivant l'apparition des symptmes ou partir du dernier moment o ils ont t vus en bonne sant (recommandation forte . The Solitaire AB stent is a scaffold that do flow blood diversion and promotes the aneurysms exclusion by thrombosis. The Use of Solitaire AB Stents in Coil Embolization of Wide-Necked Cerebral Aneurysms. The Solitaire X portfolio is designed to give you greater confidence during interventional stroke procedures with: SolitaireTM X Revascularization Device View the features and simulated use of the SolitaireTM X device Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. Case report: 63 year old female present pulsatile headache, diplopia, III. In a multinational cohort of 1,604 patients presenting with LVO in the extended window, patients selected by NCCT had comparable clinical and safety outcomes with patients selected by CTP or MRI . Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Based on smallest vessel diameter at thrombus site. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. 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. Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. With an updated browser, you will have a better Medtronic website experience. This site uses cookies to store information on your computer. ?\IY6u_lBP#T"42%J`_X MUOd 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. Campbell BC, Hill MD, Rubiera M, et al. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. The Orsiro Mission stent is MR conditional. It is possible that some of the products on the other site are not approved in your region or country. Maximum 15 min of scanning (per sequence). Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. N. Engl. If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Methods: From the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register, we included consecutive acute ischemic stroke patients (2015-2021) treated within 4.5. Read our cookie policy to learn more including how you may change your settings. 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. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. Based on bench and animal testing results. MRI Information. More information (see more) Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. 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. Initiate mechanical thrombectomy treatment as soon as possible. AIS Revascularization Products This device is supplied STERILE for single use only. You can read our Privacy Policy here. Indications, Safety, and Warnings. Goyal M, Menon BK, van Zwam WH, et al. Tomasello A. Solitaire X. Lancet. 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. &dR~% '7) W P2yob)eRUX@F&oE+7" % The patient's wallet card specifies the model number. Solitaire Literature Review Aug2022. Do you need support for procedures? MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Do not use kinked or damaged components. 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). 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. It is delivered through a standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. Products Am J Roentgenol 1999;173:543-546. 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. A randomized trial of intraarterial treatment for acute ischemic stroke. Medical Information Search Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. All current, commercially available coronary stents may be imaged at 1.5T or 3T at any time: Maximum whole-body-averaged specific absorption rate (SAR) of 2-W/kg in Normal Operating Mode. The deviceis a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. A comprehensive portfolio for all AIS techniques. FPE defined as mTICI2c/3; modified FPE defined as mTICI 2b-3. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where each product is available. 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: Mar 12 2015;372(11):1019-1030. We do not make your details available to any third parties nor do we send unsolicited emails to our members. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy WhichMedicalDevice is a FREE resource created by clinicians for clinicians. If excessive resistance is encountered during the delivery of the Solitaire X Revascularization Device, discontinue the delivery and identify the cause of the resistance. Jan 1 2015;372(1):11-20. N. Engl. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. MRI exams are safe for some devices. Stroke. Zaidat OO, Castonguay AC, Linfante I, et al. 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. 2022 The Regents of the University of California | Accessibility | Terms of Use | Privacy Policy, (T32) Biomedical Imaging for Clinician Scientists. SUMMARY: The balloon remodeling technique was initially designed for the endovascular treatment of anatomically complex aneurysms, specifically wide-neck aneurysms. Is it safe to have MRI with heart stents? Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Materials and methods: From January 2011 through January 2016, we retrospectively selected 2979 patients with acute ischemic stroke. STRATIS, SWIFT PRIME, ESCAPE, Nasa Registry, THRACE, MR CLEAN, STAR, EXTEND IA, HERMES, SEER, REVASCAT, DEFUSE 3, Note: The Solitaire X Revascularization Device was not evaluated in these studies. stenting of symptomatic middle cerebral artery stenosis and perioperative evaluation using high-resolution 3 Tesla MRI (2012 . Your use of the other site is subject to the terms of use and privacy statement on that site. Learn more about navigating our updated article layout. %PDF-1.3 Pereira VM, Gralla J, Davalos A, et al. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. 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. pull back) the device when encountering excessive resistance. 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. CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. 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 . Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Products 1,2 The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. See our stroke products, from stent retrievers to aspiration systems. It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. The idea was that the stent needed time to "settle in" and become incorporated in the vessel wall before risking displacement by magnetic forces. Do not cause delays in this therapy. 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. 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. Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. Subscribe to our newsletter. 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. 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. Under these conditions, the central portion of the lumen of the aortic component was visible. 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. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. For access to the full library of product manuals, visit the Medtronic Manual Library. Serge Bracard, Xavier Ducrocq, et al. The MRI safety information is given on the Patient Implant Card. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Do not reprocess or re-sterilize. Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire X Revascularization Device. This stent can be safely scanned in an MR system meeting the following . Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. 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. How about other GU devices like nephrostomy tubes and stents? Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. If you continue, you may go to a site run by someone else. Read MR Safety Disclaimer Before Proceeding. Stroke. 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 Randomized assessment of rapid endovascular treatment of ischemic stroke. RX Only. N. Engl. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. F= Z1SWb-h{1-9mJqc52u[(Mk[){g~,YJmnixZq:aNPWj/N4j 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 . Healthcare Professionals Healthcare Professionals The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. A total of 19 patients having under-gone intracranial stenting for aneurysms were imaged by MRI at 1.5T. 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. Do not use if the package is open or damaged. Update my browser now. Endovascular therapy with the device should be started within 6 hours of symptom onset. 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. Medtronic Data on File. N. Engl. Background The number of elderly patients suffering from ischemic stroke is rising. Please consult the approved indications for use. Update my browser now. Adverse reaction to antiplatelet/ anticoagulation agents or contrast media, Device(s) deformation, collapse, fracture or malfunction, Distal embolization including to a previously uninvolved territory, Neurologic deterioration including stroke progression, stroke in new vascular territory, and death, The risk of complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) increases as the procedure time and the number of procedures increase, User experiences major dissatisfaction with device performance. They are typically inserted during a procedure called. 2017;48(10):2760-2768. Do not advance the microcatheter against any resistance. Apr 23 2016;387(10029):1723-1731. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. 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. More information (see more) Microsurgical anatomy of the proximal segments of the middle cerebral artery. Please help keep this site free for everyone in the world! This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. Stroke. 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). Download the latest version, at no charge. Methods Between January 2015 and April 2017, 96 . The artifact may extend up to 10 mm from the implant. The information from the scan may help your doctor decide if you need another stent. Metallic stents may indeed undergo heating during RF-excitation, but this also does not seem to be a major problem even with overlapping stents or with big aortic stent-grafts, in part because flowing blood serves to diffuse away whatever heat is locally generated. 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. Registration gives you full access to all of the features of WhichMedicalDevice. AIS Revascularization Products If a stent is put into a patient's bile duct during an MRI, it will not be visible. 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. 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! Usable length that is at least as long as the length of the thrombus. Patients with angiographic evidence of carotid dissection. 2016;387(10029):1723-1731. The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. This MRI Resource Library is filtered to provide MRI-specific information. 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. Date of coronary stent placement and device manufacturer should be documented prior to MRI. Stroke. 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 |! 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 study will demonstrate safety and efficacy of the SOLITAIRE Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke. Less information (see less). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. N. Engl. 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. A stent crimping technology, which provides excellent stent retention and provides smooth surface transition across the stent and delivery system. 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. Frequent questions. 2014;45:141-145. NOTE: A patient may have more than one implanted device. Garca-Tornel , Requena M, Rubiera M, et al. First pass effect: A new measure for stroke thrombectomy devices. For each new Solitaire X Revascularization Device, use a new microcatheter.