The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. The artifact may extend up to 10 mm from the implant. 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 . Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Maximum 15 min of scanning (per sequence). We do not make your details available to any third parties nor do we send unsolicited emails to our members. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. Neurological Date of coronary stent placement and device manufacturer should be documented prior to MRI. << /Length 5 0 R /Filter /FlateDecode >> Categorised under: Jan 1 2015;372(1):11-20. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. Berkhemer OA, Fransen PS, Beumer D, et al. 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. 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 Stroke; a journal of cerebral circulation. 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. zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw
XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI Stroke. Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. WhichMedicalDevice is a FREE resource created by clinicians for clinicians. - (00:00), NV AIS Solitaire X Animation Drug-coated stents have been approved for use by the U.S. Food and Drug Administration (FDA). Since the present method of implantation is under a scleral flap, creating a great deal of friction, this study's findings confirm the safety of the Ex-PRESS with MRI testing.The findings also point to the safety of the device if placed directly under the conjunctiva, the originally proposed method of implantation. It is delivered through a standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. For best results, use Adobe Reader to view Medtronic manuals. Mar 12 2015;372(11):1019-1030. Based on smallest vessel diameter at thrombus site. Medtronic Data on File. Do not reprocess or re-sterilize. > Home The Solitaire X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. The purpose of this study was to . The best of both worlds: Combination therapy for ischemic stroke. Endovascular therapy with the device should be started within 6 hours of symptom onset. Campbell BC, Mitchell PJ, Kleinig TJ, et al. This stent or similar devices also have a role in visceral/peripheral aneurysms where a scafold is needed across the neck of an aneurysm to allow coils to be placed safely within the sac without prolapse in to the native vessel eg wide necked aneurysms. Contact Technical Support. Do you need support for procedures?
Solitaire Literature Review Aug2022. The SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤5.0 mm in diameter in . ?\IY6u_lBP#T"42%J`_X
MUOd Randomized trials of mechanical thrombectomy (MT) generally exclude patients over the age of 80 years with baseline disability. 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 . Goyal M, Demchuk AM, Menon BK, et al. The Use of Solitaire AB Stents in Coil Embolization of Wide-Necked Cerebral Aneurysms. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. AIS Revascularization Products If you consent, analytics cookies will also be used to improve your user experience. 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. Reasons for Reperfusion Failures in Stent-Retriever-Based Thrombectomy: Registry Analysis and Proposal of a Classification System 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. J. Med. Case report: 63 year old female present pulsatile headache, diplopia, III. 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. 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. 2016; 15: 113847. 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. Interventional Radiology
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.
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). &dR~% '7) W P2yob)eRUX@F&oE+7" % 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458. The Orsiro Mission stent is MR conditional. 2018;49(3):660-666. Do not use if the package is open or damaged. Carry the Patient Implant Card with you at all times and show it to any medical professional who treats you. Initiate mechanical thrombectomy treatment as soon as possible.
Indications, Safety, and Warnings.
Do not treat patients with known stenosis proximal to the thrombus site. Solitaire X Revascularization Device does not allow for electrolytic detachment. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. Cardiac stents are small, metal mesh tubes that are inserted into narrowed or blocked coronary arteries to improve blood flow to the heart. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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 information from the scan may help your doctor decide if you need another stent. Bench and animal testing may not be representative of actual clinical performance.
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. If you continue, you may go to a site run by someone else.
Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. 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. The presence of this implant may produce an image artifact. This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
Stents (non covered ). Therefore, Solitaire AB stentassisted coil embolization was demonstrated to be a safe and effective treatment for ruptured very small intracranial aneurysms. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. 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. #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. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. 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! %
Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. Stents are basically small tubes or sometimes springs that help prop arteries open. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. >
They are typically inserted during a procedure called.
Non-clinical testing has demonstrated that the Xact Carotid stent is 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. Medical Information Search This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. 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. Methods Between January 2015 and April 2017, 96 . With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. This site uses cookies to store information on your computer.
CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. 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. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. A. SUMMARY: The balloon remodeling technique was initially designed for the endovascular treatment of anatomically complex aneurysms, specifically wide-neck aneurysms. _+'$@K8)Z3M2m#rb^U>K%J]}m?lu*au&lm1Kf!J/ hiTqpCJY9[HB5=m]d5X|h ^C`h8malAb :wiN. 2017;48(10):2760-2768. Artifacts extended both inside and outside the device lumen. Background The number of elderly patients suffering from ischemic stroke is rising. 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: Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The MRI safety information is given on the Patient Implant Card. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. Flottmann F, Leischner H, Broocks G, et al. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke.
NOTE: A patient may have more than one implanted device. 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. Read our cookie policy to learn more including how you may change your settings. Find out more Keep up to date MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. 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. Serge Bracard, Xavier Ducrocq, et al. 15 minutes of scanning (i.e. 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 Registration is free and gives you unlimited access to all of the content and features of this website. If a stent is put into a patient's bile duct during an MRI, it will not be visible. Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. If the product name you seek is not listed, try looking for information by device type. Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis.
Recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke. Your opinion matters to others - rate this device or add a comment. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content.
The longterm efficacy of this technique may be improved by increasing the packing density around the aneurysmal neck and improving the hemodynamics. 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. 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. Avoid unnecessary handling, which may kink or damage the Delivery System. stream The deviceis a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. Oral presentation at: International Stroke Conference; February 9, 2022; New Orleans, LA. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2
Mar 12 2015;372(11):1009-1018. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. 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 ). Zaidat OO, Castonguay AC, Linfante I, et al.
See Table XXI in online Data Supplement 1 Downloaded from httpahajournalsorg by from MNGMT 123 at University of Virginia 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.
The powerful magnetic field of the MRI scanner may damage internal metal devices, such as a heart pacemaker. It can be scanned safely under the conditions listed in the Instructions . J. Med. Apr 23 2016;387(10029):1723-1731.
MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging Approach for Acute Endovascular Therapy - Read online for free.
The XIENCE V stent should not migrate in this MRI environment. 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. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug .
treatment of ischemic stroke among patients with occlusion.
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.
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 This device is supplied STERILE for single use only. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. Products N. Engl. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device. Medtronic creates meaningful technologies to empower AIS physicians. J. Med. MRI is base on safe interaction between radiowaves at a particular frequency and hydrogen nuclei in the body. 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. Jadhav AP, Desai SM, Zaidat OO, et al.
For access to the full library of product manuals, visit the Medtronic Manual Library. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al.
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. Jovin TG, Chamorro A, Cobo E, et al. The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. Bench testing may not be representative of actual clinical performance.
Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. Am J Roentgenol 1999;173:543-546.
When to Stop [published correction appears in Stroke. Microsurgical anatomy of the proximal segments of the middle cerebral artery. Stroke. 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. 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 . J. Med. 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. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Stroke. Precautions Inspect the product prior to use. stent dislodgment soon after left main coronary artery stenting. Stroke. Patients with known hypersensitivity to nickel-titanium. 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. 4 0 obj The patient's wallet card specifies the model number. B. With an updated browser, you will have a better Medtronic website experience. Please consult the approved indications for use. Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. %PDF-1.3 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. The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. N. Engl. Do not recover (i.e. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. 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 . per pulse sequence). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. 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 Solitaire AB stent is a scaffold that do flow blood diversion and promotes the aneurysms exclusion by thrombosis. Please consult the approved indications for use. The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio.
Is there an increased risk of IVC filters moving during MRI? Stroke. 2022;53(2):e30-e32. Indications, Safety and Warnings IFU The Solitaire X Revascularization Device is not to be used after the expiration date imprinted on the product label.
2016;47(3):798-806.
Registration gives you full access to all of the features of WhichMedicalDevice. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. A total of 20 stents were placed in 19 patients. The idea was that the stent needed time to "settle in" and become incorporated in the vessel wall before risking displacement by magnetic forces. 2018;49(10):2523-2525.
Use of appropriate anticoagulant and/or antiplatelet therapy per standard of care is recommended for use with this stent system. TR-NV13807A, TR-NV15666A, D00419703A, D00324045A. Among . Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. stenting of symptomatic middle cerebral artery stenosis and perioperative evaluation using high-resolution 3 Tesla MRI (2012 . Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Healthcare Professionals Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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. . It was a crowning achievement, as transformative for the company as it was impressive in both size and scope. "MR Conditional" stent graft treating a thoracic aneurysm (Courtesy Cook), To my knowledge, there are no currently implanted stents that are considered. You can read our Privacy Policy here. The information on this page is current as of November 2022. Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. 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).