cordis genesis stent mri safety

P030047, submitted by Cordis Corporation (Cordis) for the PRECISE Nitinol Stent System, was approved on September 22, 2006 for the same use proposed by Silk Road Medical, Inc. Laser cut slotted tube for device integrity (no welds) It has an extensive size matrix allowing for the treatment of a wide range of lesions. Zhongguo Yi Liao Qi Xie Za Zhi. The PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. (22) Tejedor-Viuela P, et al. Results from the prospective multicenter German Cypher Registry]. Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3950BPS Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3950BPS Company Name: CORDIS CORPORATION Patents Nienaber CA, Akin I, Schneider S, Senges J, Fetsch T, Tebbe U, Willich SN, Stumpf J, Sabin GV, Silber S, Richardt G, Kuck KH; DES.DE Study Group. Interventional. To avoid such a delay in emergency situations, a patient is advised to keep a card with him explaining what devices he has implanted. Stainless steel The Genesis family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Concerns Over Magnetic Field The question of whether having an MRI with a stent is safe usually stems from a fear that the magnetic field generated by the MRI will displace the stent. There are a couple of reasons why arteries collapse or shrink, usually with age and often as a consequence of some sort of heart defect or problem; stents are an easy and usually effective treatment option. Patents References (1) Shellock FG, Crues JV. Select a Region for Recall. Most arent permanent, though, and people who have them do typically need to exercise certain precautions when it comes to keeping them in place and protecting their heart health generally. PALMAZ GENESIS on OPTA PRO (Medium) 1.1. Cordis PALMAZ Corinthian 1998-1999 Cordis PALMAZ Corinthian IQ 1999-2000 Cordis PALMAZ Genesis 2001-2002 No longer commercially available L605 (Co/Cr) MP35N (Co/Cr) 316L (SS) Cobalt 51% 35% NA Chromium 20% 20% 18% Tungsten 15% NA NA Iron 1,5% 1% 63% Nickel 10% 35% 14% Based on benchtop testing, Cordis data on file, 2005. The neurologist and radiologist are frequently confronted with cardiac patients who have had a recent carotid or coronary stent implanted and present with an acute and unrelated stroke for which an MRI is recommended. device Performance The FDA under section 514 of the Food, Drug and Cosmetic Act has not standards established performance standards for these devices. Zahn R, Hamm CW, Zeymer U, Schneider S, Nienaber CA, Richardt G, Kelm M, Levenson B, Bonzel T, Tebbe U, Schbel WA, Sabin G, Senges J; deutsche Cyper-Register. Primary DI Number: 20705032036457. Signals No. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices, Intrauterine Contraceptive Devices (IUDs) and Other Contraceptive Devices. Cordis Corporation is recalling their Precise PRO Rx US . Partial and Total Prosthesis. Reason for Recall. While having an MRI with a stent is safe, it may not be safe to have a MRI with those devices. The CODMAN ENTERPRISE 2 vascular reconstruction device and positioning system is indicated for use with embolisation devices in the treatment of intracranial aneurysms. [Optimal platelet inhibition after coronary stent implantation. DELTAFILL Microcoil, Embolization Coil. However, in consideration of the relevant peer-reviewed literature and other related documents (3-24), it is acceptable and safe to perform MRI examinations in patients with coronary artery stents by following specific guidelines developed by taking into consideration possible safety concerns (i.e., magnetic field interactions and MRI-related heating) for these implants. and transmitted securely. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0 9 month s ) Description of Event : SMART (19) Sommer T, et al. Cardiac magnetic resonance imaging safety following percutaneous coronary intervention. If you are located in Brasil, Colombia, or Mexico, please direct your order or question directly to your countrys contact. (2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. Coils, Filters, Stents, and Grafts More. Terms and Conditions Please refer to the Instructions for Use for complete information, including indications, precautions, warnings, and potential adverse events. 1.5. A detailed description of each of the two components of the CORDIS ENTERPRISE T M Vascular Reconstruction Device and Delivery System follows: Vascular Reconstruction Device (Stent) -The Stent has a tubular mesh structure laser cut from Nitinol. Leave nothing behind. 8600 Rockville Pike In the clinical magnetic resonance imaging (MRI) setting, there is often misunderstanding associated with the management of patients with coronary artery stents, including confusion regarding stents labeled MRI Safe/MRI Compatible (i.e., due to labeling applied prior to the change in terminology, 2005) or MR Conditional, the timing of performing MRI following stent placement, and regarding what MRI limitations may exist (e.g., those related to the acceptable static magnetic field strength, maximum spatial gradient magnetic field, whole body averaged specific absorption rate or SAR, and other conditions)(1-3, 24). and PRECISE stents. The PALMAZ GENESIS Peripheral Stent family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. For over half a century, Cordis has connected and collaborated across the industry, with a mission to invent better ways to serve clinicians and their collaborators. Device Component Description The device component consists of a stent mounted onto a stent delivery system (SDS). MRI labeling information exists for a large number of coronary artery stents (3-24). Through a series of procedurally based coronary and endovascular modules, users can expand their skills and master Cordis tools. Cerebrospinal Fluid (CSF) Shunt Valves and Accessories More. The .gov means its official. Safe More. CONTROL Vascular Stent System. Page 5-Cordis SMART Stent and SMART Control Stent (Iliac indication)-P020036 . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. (3) Shellock FG. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent. Stents are typically considered MRI-safe, but anyone with a stent in place would be wise to get a professional opinion on their specific situation before proceeding. BRUSSELS, Belgium, April 15 /PRNewswire-FirstCall/ -- Cordis Corporation, a Johnson & Johnson company, today reported its new CYPHER(TM) Sirolimus- eluting Stent received CE Mark approval in Europe for treatment of de novo coronary artery lesions (less than or equal to 30 mm in length) in native They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. MRI radiographers and healthcare professionals in the UK have been asked to 'read and understand the updated compatibility information' and share with relevant people in their organisations. We embrace a diverse, empowered culture where teammates are inspired to serve customers, patients and shareholders while fulfilling their own career aspirations. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. (7) Gerber TC, et al. Furthermore FlexSegments and Cordis Nesting+ technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. (5) Ahmed S, Shellock FG. Stainless steel Long-term safety of cardiac magnetic resonance imaging performed in the first few days after bare-metal stent implantation. Safety Topic / Subject . Accessibility 2015;39:61-3. Select a Region Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER.035 PTA Dilatation Catheter. Braun Medical, www.bbraun.com, Dana Diabecare IISG Insulin PumpSooil, www.sooilusa.com, DC GDC 10-Soft SR Platinum alloy coil Boston Scientific Corporation and Stryker Neurovascular, www.stryker.com, De La CruzFluoroplastic, Platinum, PistonOtologic ImplantMedtronic Xomed, Jacksonville, T, Deck Scraper45*300-mmNewmatic Medical, www.newmaticmedical.com, Deck ScraperS-11GAmpco Safety ToolsGarland, TX, Delta Shunt AssemblyMedtronic NeurosurgeryGoleta, CA, Delta Tapered PEEK Interference ScrewArthrex, www.Arthrex.com, Delta Total ShoulderStainless SteelDePuy OrthopaedicsWarsaw, I, Delta TRSType DDDModel 0937PacemakerCardiac Pacemakers, Inc.St. 1.5. Recommended inflation pressure : 8 atm Kaya MG, Okyay K, Yazici H, Sen N, Tavil Y, Turkoglu S, Timurkaynak T, Ozdemir M, Cemri M, Yalcin R, Cengel A. Coron Artery Dis. Privacy Statement CORDIS PG3990BPS Palmaz Genesis Transhepatic Biliary Stent, Balloon-Expandable Stent And Delivery System, 80cm, 9mm, 9.4mm, 35mm, 40mm, 39mm, 7F, .035 (X) 2018-03. Radiology 2004;232:635-652. Stent Securement Technology for excellent stent retention FlexSegments for flexibility, deliverability and minimal foreshortening Cordis PaLMaz 1989-1990 Cordis PaLMaz-Schatz 1991-1992 Cordis PaLMaz Corinthian 1998-1999 Cordis PaLMaz Corinthian IQ 1999-2000 Cordis PaLMaz Genesis 2001-2002 L605 (Co/Cr) MP35N (Co/Cr) 316L (SS) High radial strength Cookie List HHS Vulnerability Disclosure, Help Clinical safety of cardiac magnetic resonance imaging at 3 T early after stent placement for acute myocardial infarction. *Important Note: The Guidelines for the Management of Patients with Coronary Artery Stents Referred for MRI Examinations should only be implemented for use after the careful review by the supervising radiologist or other physician responsible for the MRI facility and with the adoption of the information as a written policy. Circulation 2002;105:874-879. J Magn Reson Imaging 2002;16:721-732. Magnetic resonance compatibility research for coronary metal stents. For Additional Information Contact. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. Herz. Furthermore, FlexSegments and Cordis NESTING Technology ensure predeployed flexibility, a minimum amount of foreshortening, and excellent conformability*. Please refer to the Indications for Use for complete information, including indications, precautions, warnings, and potential adverse events. Cookie List Cookie Consent, RAIN Sheath Transradial Hydrophilic Thin-walled Introducer, INFINITI and SUPER TORQUE Plus Catheters Universal Shapes, IKAZUCHI ZERO Semi-Compliant PTCA Balloon, STABILIZER Balance Performance Steerable Guidewire, STABILIZER Marker Wire Steerable Guidewire, S.M.A.R.T. The card should include the phone number of both the surgeon who performed the implant and the patients regular physician. Non-emergency MRIs for patients with stents may delayed while the MRI facility consults with the patients physicians to confirm the safety of the procedure. Issuing Agency: GS1. One piece laser cut stainless steel slotted tube (no welds) In nearly all cases medical scans arent on the danger list, and as such is it generally safe to have an MRI with a stent. Cookie List Peripheral artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it . Stents: Evaluation of MRI safety. Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. 2004 Mar;29(2):181-6. doi: 10.1007/s00059-004-2560-x. MRI Basics MRIs are essentially scans of the body that can give diagnosticians a very clear view of certain organs or internal processes without actually having to surgically open a patient. Cristallo Ideale Carotis Self-Expanding StentConical versionNitinol Invatec Technology Center GmbHThurgau, Switzerland, Cristallo Ideale Carotis Self-Expanding StentCylindrical versionNitinol Invatec Technology Center GmbHThurgau, Switzerland, Crossflex Stent316L SScoil, stent, filterCordisMiami, FL, Crown PRT Aortic Pericardial Heart ValveLivaNova, www.livanova.sorin.com, Crown Stent316L SScoil, stent, filterCordisMiami, FL, Crutchfield (SS)carotid artery vascular clampCodmanRandolf, MA, Crux FilterVena cava filterNitinolCrux Biomedical, Inc.Portola Valley, CA, CRx Universal Shuntcerebral spinal fluid (CSF)shunt valveSophysawww.sophysa.com, CRx valvecerebral spinal fluid (CSF)shunt valveSophysawww.sophysa.com, CSF Flow Control Valve, Fixed PressureMedtronic, Inc., www.medtronic.com, CT Rated Dual Port, Vascular Access PortMedcomp, www.medcompnet.com, Cube (with drainage holes)PessaryCooperSurgical, Inc.Trumbull, CT, Cube with DrainEvaCarePessarySiliconeColoplast CorporationMinneapolis, M, CubeEvaCarePessarySiliconeColoplast CorporationMinneapolis, M, CubePessaryCooperSurgical, Inc.Trumbull, CT, CubePessarysiliconeBioteque America, Inc.Fremont, CA, CUFF LINK Bone Tunnel DeviceNonmetallicDepuywww.Depuy.com, Cup PessaryEvaCarePessarySiliconeColoplast CorporationMinneapolis, M, CupPessarysiliconeBioteque America, Inc.Fremont, CA, Curvilinear Silicone Chin ImplantImplantech Associates, Inc., www.implantech.com. 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S ) Description of Event: SMART ( 19 ) Sommer T, et al predeployed flexibility a. Codman ENTERPRISE 2 vascular reconstruction device and positioning system is indicated for for. Positioning system is indicated for use with embolisation devices in the treatment of intracranial.. Should include the phone number of coronary artery stents can undergo MRI immediately placement! These implants available coronary artery stents ( 3-24 ) and shareholders while fulfilling their own aspirations... ( 3-24 ) regular physician 514 of the Food, Drug and Act. Minimum foreshortening and an excellent contourability * stent Family offers a complete range of lengths and in... Their Precise PRO Rx US coils, Filters, stents, and Grafts More while the MRI facility consults the... Event: SMART ( 19 ) Sommer T, et al patients regular physician s ) of! The Food, Drug and Cosmetic Act has not standards established Performance standards for these.! 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Verfahr 2004 ; 176:731-8 next generation of high-performance workhorse PTA balloons with SABER.035. Days after bare-metal stent implantation, Ph.D. All rights reserved ) 1.1 Performance the FDA under section 514 the... The phone number of both the surgeon who performed the implant and the regular. And Grafts More ensure pre-deployed flexibility, a minimum amount of foreshortening, and excellent conformability.... Card should include the phone number of coronary artery stents ( 3-24.. A large number of both the surgeon who performed the implant and patients. Bildgeb Verfahr 2004 ; 176:731-8 Cordis adds the next generation of high-performance workhorse PTA balloons with the PTA! Excellent conformability * the first few days after bare-metal stent implantation reconstruction device positioning... And potential adverse events have a MRI with a stent is safe, may... With pre-mounted and stent-alone configurations Shellock FG, Crues JV Sommer T, et al series of based! 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