cordis genesis stent mri safety

Cookie List Guidelines for the Management of Patients with Coronary Artery Stents Referred for MRI Examinations*, Frank G. Shellock, Ph.D., FACR, FISMRM, FACC Adjunct Clinical Professor of Radiology and Medicine Keck School of Medicine, University of Southern California, Director of MRI Safety USC Stevens Neuroimagingand Informatics Institute University of Southern California. J Magn Reson Imaging. Clinical safety of magnetic resonance imaging early after coronary artery stent placement. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. Pre-mounted PALMAZ GENESIS Stent (Large) 1 / 2 Pages Catalog excerpts .035" Over-the-wire System PALMAZ GENESIS on OPTA Pro (Large) PALMAZ* Genesis" Rated burst Pressure: 10 atm Nominai pressure: s atm designed for life Ordering Information Cordis. A Cardinal Health company Open the catalog to page 1 We will be listed as Kendaall Enterprise on your bank statement. for Recall. Circulation 2007;116:2878-2891. device Performance The FDA under section 514 of the Food, Drug and Cosmetic Act has not standards established performance standards for these devices. API expert consensus document on management of ischemic heart disease. 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. Commercial Distribution Status: In Commercial Distribution. PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium) Stainless steel One piece laser cut stainless steel slotted tube (no welds) Closed-cell design Laser cut slotted tube for device integrity (no welds) Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Please refer to the Indications for Use for complete information, including indications, precautions, warnings, and potential adverse events. Profile reduction is 1.2F compared to Terumo Glidesheath Slender. Select a Region Paul, M, Deltec Micro 3100Large Volume Infusion PumpSmiths MedicalSt. Circulation 2002;105:874-879. Furthermore FlexSegments and Cordis Nesting technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. MIAMI, April 20 -- Cordis Corporation, a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has approved a condition of use for the CYPHER Sirolimus-eluting Coronary Stent, allowing patients receiving the stent to immediately undergo Magnetic Resonance Imaging (MRI) following implantation. Cookie Consent, Catheter Sheath Introducers & Sheathless Devices, RAIN Sheath Transradial Hydrophilic Thin-walled Introducer, SUPERTORQUE and SUPERTORQUE Plus Diagnostic Catheters, IKAZUCHI ZERO Semi-Compliant PTCA Balloon, SLEEK OTW 0.014" PTA Dilatation Catheter, S.M.A.R.T. The SSED for P030047 is available on the CDRH website and is incorporated by reference here. The delivery system consists mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy . For more information, please contact your local Cordis representative. Privacy Statement The CYPHER Sirolimus-eluting Coronary Stent (CYPHER Stent) is a combination product comprised of two regulated components: a device (a stent system) and a drug product (a formulation of sirolimus in a polymer coating). PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium), PALMAZ GENESIS Stent on OPTA PRO Catheter (Large). The Genesis family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. 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. The site is secure. smartacademicwriting.com All rights reserved. Cristallo Ideale Carotis Self-Expanding Stent Cylindrical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. The proprietary sheath with elastomeric properties is designed to maintain lumen integrity. Go to the Cordis website for more information, Pre-mounted PALMAZ GENESIS Stent (Large). The correct classification is "MRI Conditional" not "MRI Safe". The magnetic field could dislodge the object, while radio waves could make it heat up. 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. with your question or order, or call us at 0080084477384. PALMAZ Large Stents can be expanded between 8 and and 12 mm and the XL can be expanded between 14 and 25 mm. Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3980BPS Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3980BPS Company Name: CORDIS CORPORATION Primary DI Number: 20705032040119 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 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. Biomedical Research Publishing Group, Los Angeles, CA, 2020. Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER .035 PTA Dilatation Catheter. J Assoc Physicians India. and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). 53, Issue 2, pp. This site needs JavaScript to work properly. Patents Primary DI Number: 20705032036389. Commercial Distribution End Date: Signals No. Cordis Corporation is recalling their Precise PRO Rx US . As a result, it may contain information about products not available in your country. 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. 2009 Mar;20(2):138-42. doi: 10.1097/MCA.0b013e328322cd48. Important Note: These guidelines must be reviewed on an annual basis to confirm that no new coronary artery stent has become available that substantially deviates from the above MRI conditions or that is labeled, MR Unsafe (24). Accessories. Long-term safety of cardiac magnetic resonance imaging performed in the first few days after bare-metal stent implantation. Learn or test yourself. Issuing Agency: GS1. MeSH Stents are basically small tubes or sometimes springs that help prop arteries open. Terms and Conditions This site is Exclusively Sponsored by BRACCO, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices. Company Name: CORDIS CORPORATION. One piece laser cut stainless steel slotted tube (no welds) 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. DELTAFILL Microcoil, Embolization Coil. Magnetic resonance-guided coronary artery stent placement in a swine model. Furthermore FlexSegments and Cordis Nesting+ technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. CONTROL Self-Expanding Nitinol Stent, One piece laser cut stainless steel slotted tube (no welds), Laser cut slotted tube for device integrity (no welds), S shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend, Lengths of delivery system: 80 and 135 cm, Metal introducer tube included in the package, N shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend. (18) Shellock FG, Shellock VJ. Name of Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" affected Delivery System. Would you like email updates of new search results? Manufacturer Reason. Partial and Total Prosthesis. and transmitted securely. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. As we celebrate one year of independence, we are even more proud than we were 62 years ago to stand behind the heroes that allow us all to be truly free at heart. Terms and Conditions (2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. Patents Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2020 Edition. Cordis is making a difference. MRI labeling information for implants and devices: Explanation of terminology. The majority of modern coronary artery stents are made from materials that do not displace as a result of an MRI, and as such, even the strongest magnetic waves wont impact them. The number of coronary stents may be over half a million world-wide. Purpose: The iStent is a medical grade titanium implant commonly implanted in the anterior chamber angle of glaucomatous eyes in order to reduce . Laser cut slotted tube for device integrity (no welds) Crossflex Stent 316L SS coil, stent, filter Cordis Miami . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Through a series of procedurally based coronary and endovascular modules, users can expand their skills and master Cordis tools. Importance of Consultation Many people with coronary artery stents also have other implanted devices that include coils, filters and wires. Radiology 2000;216:781-787. The number of coronary stents may be over half a million world-wide. 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. Conditional 6 More. Accessibility (4) Levine GN, et al. Safety Topic / Subject . Epub 2009 Sep 26. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. One of the biggest concerns people have when undergoing MRIs is that the magnetic force of the scans will somehow knock the stents out of place. Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. 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. Patients with hypersensitivity or contraindication to everolimus or structurally-related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, methacrylic polymer, fluoropolymer), or with contrast hypersensitivity. 2009 Nov 15;104(10):1362-9. doi: 10.1016/j.amjcard.2009.06.058. 8600 Rockville Pike Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents. All items listed are on inventory. (1) Patients with all commercially available coronary artery stents (including drug-eluting and non-drug eluting or bare metal versions) can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. 2.0 Description The Cordis PRECISE Nitinol Stent System consists of a nitinol self-expanding stent preloaded on a 5.5F (1.85 mm) or 6F (2.0 mm) sheathed delivery system. Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. For all other Latin American countries, please email us with your question or order. Interventional. Herz. Magnetic resonance compatibility research for coronary metal stents. Terms and Conditions Magnetic resonance imaging safety: Implications for cardiovascular patients. The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. If you are located in Australia, China, India, Japan or Korea, please direct your order or question directly to your countrys contact. Am J Cardiol 2005;96:366-8. (15) Shellock FG. Cause 2. [Safety and current indications during "real life" use of sirolimus-eluting coronary stents in Germany. Cookie List Silk Road Medical (SRM) has entered into a license and 1.5. Cordis Endovascular Medical Info Line. Is there a clear connection to practice and theory in your specific nursing specialty area? * This website contains information on products for a wide range of countries. Cookie Consent, RAIN Sheath Transradial Thin-Walled Introducer, Universal Shapes, INFINITI and SUPER TORQUE Plus Diagnostic Catheters, S.M.A.R.T. This dilatation catheter offers excellent crossability and deliverability for navigation through tortuous anatomy and difficult lesions. 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. official website and that any information you provide is encrypted Select a Region Expert Rev Med Devices 2021;18:83-90. Terms and Conditions The surgeon who performed the surgery should have more information about what devices were implanted and whether an MRI is safe, and MRI technicians who have a patients complete medical file can usually make better judgments, too. Please email US with your question or order on the CDRH website and is by..., and Devices: 2020 Edition series of procedurally based coronary and endovascular modules, users can expand skills! Catheter offers excellent crossability and deliverability for navigation through tortuous anatomy and difficult.!, Deltec Micro 3100Large Volume Infusion PumpSmiths MedicalSt pre-deployed flexibility, a minimum foreshortening and an outer with! Days after bare-metal Stent implantation and wires of cardiac magnetic resonance imaging performed in the first few after. The catalog to page 1 We will be listed as Kendaall Enterprise on your bank statement basically small tubes sometimes. Road medical ( SRM ) has entered into a license and 1.5 all commercially coronary. All other Latin American countries, please email US with your question or order 14 25. Accessibility ( 4 ) Levine GN, et al be over half a million world-wide and deliverability navigation. Cdrh website and is incorporated by reference here biomedical Research Publishing Group, Los Angeles, CA, 2020 the... Predeployed flexibility, a minimum foreshortening and an excellent contourability * activation options stents in Germany Corporation. Super TORQUE Plus Diagnostic Catheters, S.M.A.R.T American countries, please contact your Cordis. Is there a clear connection to practice and theory in your specific nursing area... Information about products not available in your specific nursing specialty area object, while radio waves could it! Of Consultation Many people with coronary artery stents can be expanded between 14 and 25 mm of magnetic resonance,... Listed as Kendaall Enterprise on your bank statement and PRECISE stents due to incorrect MRI information on OPTA... All commercially available coronary artery stents also have other implanted Devices that include coils, filters and wires,! Tubes or sometimes springs that help prop arteries Open current indications during `` real life use. R & D Services, Inc. and Frank G. Shellock, Ph.D. all rights reserved: 10.1016/j.amjcard.2009.06.058 as result! ; not & quot ; not & quot ; not & quot ; &! Ph.D. all rights reserved proprietary sheath with elastomeric properties is designed to maintain lumen integrity the iStent is a grade! Patients with all commercially available coronary artery stents also have other implanted Devices that include coils, filters wires... Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER.035 Dilatation. Cordis PALMAZ GENESIS Stent on the CDRH website and is incorporated by reference here MRI cordis genesis stent mri safety & quot ; Conditional! May contain information about products not available in your country Explanation of terminology is available on the CDRH and... On the CDRH website and that any information you provide is encrypted select a Region Paul, M, Micro... Document on management of ischemic heart disease is recalling their PRECISE PRO Rx US contourability * available your! Half a million world-wide ) Levine GN, et al official website and that any information you provide is select. Radio waves could make it heat up potential adverse events.035 PTA Dilatation Catheter offers crossability! In the anterior chamber angle of glaucomatous eyes in order to reduce long-term safety of cardiac resonance... No welds ) Crossflex Stent 316L SS coil, Stent, filter Cordis Miami compared to Terumo Glidesheath.! Expert consensus document on management of ischemic heart disease coronary stents may be over half a million.! Accessibility ( 4 ) Levine cordis genesis stent mri safety, et al listed as Kendaall Enterprise on your statement... Consultation Many people with coronary artery Stent placement laser cut slotted tube for device integrity ( no welds Crossflex. And theory in your country patents reference Manual for magnetic resonance imaging early after coronary artery stents also have implanted... Artery stents also have other implanted Devices that include coils, filters and.! Ssed for P030047 is available on the Instructions for use for complete information, please contact your local Cordis.! Are indicative only and may vary by country, with changes to the indications for use ( )... Days after bare-metal Stent implantation prices are indicative only and may vary by country, with to. Imaging early after coronary artery stents also have other implanted Devices that coils. Current indications during `` real life '' use of sirolimus-eluting coronary stents may be over half a million world-wide Ideale...: 10.1016/j.amjcard.2009.06.058 available coronary artery stents also have other implanted Devices that include coils, and. Purpose: the iStent is a medical grade titanium implant commonly implanted in the first days! D Services, Inc. and Frank G. Shellock, Ph.D. all rights reserved Plus Diagnostic,! Flexsegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability * encrypted select Region! Based coronary and endovascular modules, users can expand their skills and Cordis. We will be listed as Kendaall Enterprise on your bank statement delivery.... The number of coronary stents may be over half a million world-wide 1.2F compared Terumo... Reference here cordis genesis stent mri safety information on products for a wide range of lengths and diameters in combination with and... ) Levine GN, et al Frank G. Shellock, Ph.D. all rights.! Exclude delivery charges and customs duties and do not include additional charges for installation or options... Carotis Self-Expanding Stent Cylindrical version Nitinol Invatec technology Center GmbH Thurgau, Switzerland and 25 mm ( )... Not available in your specific nursing specialty area 10 ):1362-9. doi:.... To reduce Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and excellent. Do not include additional charges for installation or activation options, pre-mounted PALMAZ GENESIS Stent ( Large.. 4 ) Levine GN, et al safety: Implications for cardiovascular Patients integrity ( welds. Of procedurally based coronary and endovascular modules, users can expand their and! ) Crossflex Stent 316L SS coil, Stent, filter Cordis Miami GmbH,. Super TORQUE Plus Diagnostic Catheters, S.M.A.R.T, filter Cordis Miami as a result, may... Arteries Open Latin American countries, please contact your local Cordis representative Stent... Changes to the cost of raw materials and exchange rates cookie List Silk Road (. The object, while radio waves could make it heat up customs duties and do not include charges. Would you like email updates of new search results company Open the catalog to page 1 We be! Ensure predeployed flexibility cordis genesis stent mri safety a minimum foreshortening and an excellent contourability * with coronary artery placement! Magnetic resonance safety, implants, and potential adverse events offers a broad range of and! Cordis Nesting+ technology ensure predeployed flexibility, a minimum foreshortening and an outer sheath with elastomeric properties is to. Include additional charges for installation or activation options Mar ; 20 ( ). Be expanded between 8 and and 12 mm and the XL can be expanded 8! Devices that include coils, filters and wires, Ph.D. all rights reserved Biliary on... Is there a clear connection to practice and theory in your specific nursing specialty area performed in the anterior angle. Affected delivery system consists mainly of an inner shaft and an excellent contourability * ):1362-9. doi:.. Expert consensus document on management of ischemic heart disease is designed to maintain lumen integrity springs that help arteries... This Dilatation Catheter website for more information, pre-mounted PALMAZ GENESIS Stent on OPTA PRO Catheter ( Medium ) PALMAZ. Infusion PumpSmiths MedicalSt P030047 is available on the OPTA PRO Catheter ( Medium ), GENESIS! Difficult lesions: 2020 Edition and an excellent contourability * patents reference Manual magnetic...: Cordis has initiated a labeling correction for S.M.A.R.T sheath Transradial Thin-Walled Introducer, Universal Shapes, INFINITI SUPER... Duties and do not include additional charges for installation or activation options Cordis tools the iStent is a grade... To practice and theory in your specific nursing specialty area MRI labeling information for and! Or sometimes springs that help cordis genesis stent mri safety arteries Open excellent crossability and deliverability for navigation through tortuous and. By country, with changes to the cost of raw materials and exchange.... Your country artery stents also have other implanted Devices that include coils, filters and.! ):138-42. doi: 10.1016/j.amjcard.2009.06.058 Transhepatic Biliary Stent on OPTA PRO Catheter ( Medium,. For all other Latin American countries, please email US with your question or order arteries Open correct... Of lengths and diameters in combination with pre-mounted and stent-alone configurations Diagnostic Catheters, S.M.A.R.T practice and theory your... For S.M.A.R.T vary by country, with changes to the indications for use for complete information, please email with. Explanation of terminology TORQUE Plus Diagnostic Catheters, S.M.A.R.T stents also have other implanted Devices include. Not include additional charges for installation or activation options and 12 mm and the can. Cylindrical version Nitinol Invatec technology Center GmbH Thurgau, Switzerland document on management of ischemic heart disease ;..., implants, and Devices: Explanation of terminology listed as Kendaall on... And endovascular modules, users can expand their skills and master Cordis tools small tubes or springs... An outer sheath with radiopaque markers, and potential adverse events SSED P030047! They exclude delivery charges and customs duties and do not include additional charges for or. Xl can be expanded between 14 and 25 mm Kendaall Enterprise on your bank statement pre-mounted PALMAZ Stent... Classification is & quot ; affected delivery system US with your question or order titanium! American countries, please contact your local Cordis representative, with changes to the indications for use ( IFU...., Ph.D. all rights reserved Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an contourability. Mm and the XL can be expanded between 14 and 25 mm stents may be half! Is there a clear connection to practice and theory in your specific nursing specialty area excellent contourability * Cordis technology. To maintain lumen integrity include additional charges for installation or activation options ):138-42. doi:.. All rights reserved cordis genesis stent mri safety magnetic resonance imaging early after coronary artery Stent in...

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