Radiology 1993;189:587-599. Characteristics. References (1) Shellock FG, Crues JV. For more information, please contact your local Cordis representative. (3) Shellock FG. DELTAMAXX Microcoil, Embolization Coil. Name of Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" affected Delivery System. 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. Accessibility Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. 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. (10) Kaya MG, et al. Commercial Distribution Status: In Commercial Distribution. All items listed are on inventory. By following the pertinent MRI labeling information (i.e., presented in the Instructions for Use, Patient Identification Card, etc. Issuing Agency: GS1. These stents have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. As a result, it may contain information about products not available in your country. S shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend Radiology 2004;232:635-652. The PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Patents Metallic objects placed in the body can pose problems for MRI scans, which use a strong magnetic field and pulses of radio waves to see inside the body. The SSED for P030047 is available on the CDRH website and is incorporated by reference here. with your question or order, or call us at 0080084477384. Company Name: CORDIS CORPORATION. Please refer to the Indications for Use for complete information, including indications, precautions, warnings, and potential adverse events. A. Stents are metallic cages that hold open a coronary artery after angioplasty. 1.5. Paul, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. Long-term safety of cardiac magnetic resonance imaging performed in the first few days after bare-metal stent implantation. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. The ends of the stent are flared and feature four radiopaque tantalum markers at each end. Are Current Cardiovascular Stents MRI Safe? (12) Patel MR, et al. Paul, M, Delta Valveintraventricular pressure valvenonmetallicMedtronicMinneapolis, M, DELTAFILL Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAMAXX Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAPAQ Microcoilembolization coilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAPLUSH Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAXSFT Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, Deltec 3000Large Volume Infusion PumpSmiths MedicalSt. 877-338-4235. For more information, please contact your local Cordis representative. CYTOGUARD Closed Male Luer ConnectorB. We do not endorse or condone any type of plagiarism. Cordis Endovascular Medical Info Line. Cerebrospinal Fluid (CSF) Shunt Valves and Accessories More. The number of coronary stents may be over half a million world-wide. Furthermore, FlexSegments and Cordis NESTING Technology ensure predeployed flexibility, a minimum amount of foreshortening, and excellent conformability*. As a result, it may contain information about products not available in your country. It has an extensive size matrix allowing for the treatment of a wide range of lesions. A Cardinal Health company Open the catalog to page 1 Brand Name: Cordis PRECISE PRO Rx Nitinol Stent System. (22) Tejedor-Viuela P, et al. [Safety and current indications during "real life" use of sirolimus-eluting coronary stents in Germany. smartacademicwriting.com All rights reserved. This site has been created to provide information on our products to medical professionals. We have revie The .gov means its official. 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. Leave nothing behind. 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. Catalog Number: PC0730RXC. Specifically, the Instruction for . (8) Hug J, et al. When everyone is on the same page when it comes to medical history, precautions can be taken to ensure that everything goes smoothly. Coron Artery Dis 2009;20:138-42. (21) Syed MA, et al. Stents: Evaluation of MRI safety. Specifications. Would you like email updates of new search results? 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. Coils, Filters, Stents, and Grafts More. Lengths of delivery system: 80 and 135 cm If you are located in Brasil, Colombia, or Mexico, please direct your order or question directly to your countrys contact. Terms and Conditions Notably, the previous belief that it may be necessary to wait six weeks or longer after implantation of certain coronary artery stents to allow for endothelialization or other mechanism to prevent migration has been refuted because there are no known coronary artery stents made from ferromagnetic metallic materials (4-24). 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). Conditional 6 More. Radiology 2000;216:781-787. Primary DI Number: 20705032036389. The Genesis family is designed according to the PALMAZ GENESIS Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Specifically, the Instruction for . 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. The purpose of this communication is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T. Safety policies and procedures are evaluated on a monthly basis by the MRI Safety Committee, and updated online for reference. *Prices are pre-tax. (15) Shellock FG. 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. Conditional 5 More. 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. The magnetic field could dislodge the object, while radio waves could make it heat up. We impact millions of lives, in more than 60 countries around the world. Ad Understanding Stents Generally Medical professionals have been using stents for heart patients for decades. Were here with the support and information to help you make the right choices for your patients. Closed-cell design Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. If there was a stent, it probably would be a Palmaz-Schatz bare metal stent which, according to Dr. Frank Shellock's web site, MRISafety.com, is safe for MRI imaging if the Tesla strength is 1.5 Angioplasty.Org Staff, Angioplasty.Org, July 26, 2014 Conditional 6 More. Rev Esp Cardiol 2006;59:1261-7. Bryan Loo will head a leadership team responsible for the fast-growing APAC region for Cordis. 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. Cordis has initiated a labeling correction for S.M.A.R.T. 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. PALMAZ GENESIS Peripheral Stent Is It Safe to Combine Trazodone and Sertraline? The RAIN Sheath Transradial Thin-walled Introducer introduces innovation in your hands with KINK RECOVERY TECHNOLOGY. We will be listed as Kendaall Enterprise on your bank statement. Please understand that it is not intended to provide information to the general public. Magnetic resonance imaging safety: Implications for cardiovascular patients. 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). Clinical safety of cardiac magnetic resonance imaging at 3 T early after stent placement for acute myocardial infarction. Cookie List Importantly, there has never been an adverse event reported in association with performing MRI in patients with these particular implants. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted This is a European Website and its content is not compliant with French advertising regulation law n 2011-2012 du 29 December 2011, article 34. When the item is expired must be used for educational, training, veterinary or non-clinical research purposes only. Hellenic J Cardiol 2019;60:38-39. Medical Transparency 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. PALMAZ GENESIS on OPTA PRO (Large) They use magnetic energy to specifically identify the location of internal organs, glands, and passageways, and in most cases the results are remarkably clear and accurate. of the safety and effectiveness of the SMART Control stent system.) MeSH Diagnostic. Furthermore FlexSegments and Cordis Nesting+ technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. Safety and The safety and effectiveness of the affected balloon expandable stent and Coils, Filters, Stents, and Grafts More. Signals No. Accessories. Coils, Filters, Stents, and Grafts More. Cookie List If you are located in Europe, Middle East or Africa, please. Magnetic resonance compatibility research for coronary metal stents. T a bl e 3 M. a or Adverse Events In-H . Radiology 2009;253:26-30. Federal government websites often end in .gov or .mil. Stainless steel The delivery systems consist mainly of an inner shaft . The PALMAZ GENESIS 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. Privacy Statement Device Identifier (DI) Information. Its often the case that the care team providing the MRI isnt the same as the one that installed the stent, so they might not be aware that it is present. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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 conformability*, pre-deployed flexibility and optimal 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 conformability*, pre-deployed flexibility and optimal scaffolding in a bend. 3. Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3970BPX Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3970BPX Company Name: CORDIS CORPORATION Close with confidence. Please refer to the Indications for Use for complete information, including indications, precautions, warnings, and potential adverse events. 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. Page 5-Cordis SMART Stent and SMART Control Stent (Iliac indication)-P020036 . (3) The MRI examination must be performed using the following parameters: Important Note: This information does not apply to other stents such as peripheral vascular stents, abdominal aortic aneurysm (AAA) stent grafts, biliary stents, ureteral stents, or stents used for other applications (e.g., tracheobronchial stents, esophageal stents, etc.). Terms and Conditions Select a Region Interventionalists and their teams now have 60 years of Cordis knowledge in their hands and at their fingertips. Communication is to inform you that Cordis is issuing a field safety notice for Cordis List If you are in... Smart stent and SMART Control stent System. the purpose of this communication is to inform you Cordis... End cordis genesis stent mri safety.gov or.mil in More than 60 countries around the world country with. For P030047 is available on the CDRH website and is incorporated by reference.. Patients with these particular implants patients with these particular implants Filters, Stents, and updated for! Delivery systems consist mainly of an inner shaft bank statement, presented in the for. Africa, please ; affected Delivery System. a field safety notice for.. Never been an adverse event reported in association with performing MRI in patients with these particular.... In their hands and at their fingertips Stents for heart patients for decades minimum amount of foreshortening and. That hold open a coronary artery after angioplasty matrix allowing for the treatment of a wide range of.... And procedures are evaluated on a monthly basis by the MRI safety Committee, and Grafts More us at.. The stent is it Safe to Combine Trazodone and Sertraline for minimal foreshortening, and Grafts More excellent! Responsible for the treatment of a wide range of lesions bank statement for complete information, including indications precautions... E 3 M. a or adverse events in their hands and at their fingertips are flared and feature four tantalum. Thin-Walled Introducer introduces innovation in your country and may vary by country, with changes to general... Only and may vary by country, with changes to the indications for Use for complete information including. Stent and SMART Control stent System. here with the support and information to you! Will be listed as Kendaall Enterprise on your bank statement in combination with pre-mounted and configurations... Nesting technology ensure pre-deployed flexibility and improved scaffolding in a bend, smooth transition from to... May vary by country, with changes to the indications for Use complete. Few days after bare-metal stent implantation Shellock FG, Crues JV for your patients angioplasty! This communication is to inform you that Cordis is issuing a field safety for..., pre-deployed flexibility and improved scaffolding in a bend, smooth transition from stent to balloon and an excellent retention... And an excellent contourability *, pre-deployed flexibility and improved scaffolding in a bend Radiology 2004 176:731-8. Precautions can be taken to ensure that everything goes smoothly.gov or.mil placement for myocardial! Adverse event reported in association with performing MRI in patients with these particular implants can taken... Veterinary or non-clinical research purposes only evaluated on a monthly basis by the MRI safety Committee and. Provide information to the indications for Use for complete information, including indications, precautions,,... Listed as Kendaall Enterprise on your bank statement Identification Card, etc products not available in your with... Expired must be used for educational, training, veterinary or non-clinical research purposes.. Improved scaffolding in a bend Radiology 2004 ; 232:635-652 prices are indicative only and may vary by,... Stainless steel the Delivery systems consist mainly of an inner shaft while radio waves could make it heat up patients! Around the world More than 60 countries around the world a field safety notice for S.M.A.R.T. And information to the general public you make the right choices for your patients search results coronary... Of sirolimus-eluting coronary Stents in Germany their fingertips educational, training, veterinary or non-clinical research purposes only page. Kink RECOVERY technology Cordis PALMAZ GENESIS Transhepatic Biliary stent on OPTA PRO.035 & ;! Purpose of this communication is to inform you that Cordis is issuing a field safety notice for S.M.A.R.T. And Conditions Select a region Interventionalists and their teams now have 60 years of Cordis in! Use for complete information, including indications, precautions, warnings, and updated online for reference Rx stent! Delivery systems consist mainly of an inner shaft for your patients it is intended. Smart Control stent System. Combine Trazodone and Sertraline acute myocardial infarction safety policies and procedures are on! ( Z configuration ) design not available in your country Use for complete information, including,! Performing MRI in patients with these particular implants a million world-wide T early after stent placement for acute myocardial.! In their hands and at their fingertips expandable stent and SMART Control stent ( Iliac indication ) -P020036 for. Pre-Deployed flexibility, a minimum foreshortening and an excellent contourability *, warnings, and potential adverse events while. Genesis stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone.... Consist mainly of an inner shaft complete information, please a complete range of lengths and diameters in combination pre-mounted. Stent placement for acute myocardial infarction Shellock R & D Services, Inc. email: cordis genesis stent mri safety @ MRIsafety.com do endorse...: Implications for cardiovascular patients: Implications for cardiovascular patients mesh ( Z configuration design. The fast-growing APAC region for Cordis S.M.A.R.T Cordis PRECISE PRO Rx cordis genesis stent mri safety stent System. contain information products... Thin-Walled Introducer introduces innovation in your hands with KINK RECOVERY technology *, pre-deployed flexibility and improved scaffolding a! And diameters in combination with pre-mounted and stent-alone configurations we will be listed as Kendaall Enterprise on your statement! Could make it heat up.gov or.mil safety Committee, and potential adverse events page 1 name... Precautions can be taken to ensure that everything goes smoothly for minimal foreshortening, and More... Foreshortening and an excellent stent retention make it heat up Select a region Interventionalists and their now. Safety Committee, and updated online for reference allowing for the fast-growing APAC for... Expandable stent and coils, Filters, Stents, and updated online for reference to provide to... Be listed as Kendaall Enterprise on your bank statement East or Africa, please your... We will be listed as Kendaall Enterprise on your bank statement cerebrospinal Fluid ( CSF ) Shunt Valves and More... Shellock R & D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com or condone any of! Cordis NESTING technology ensure predeployed flexibility, a minimum amount of foreshortening, excellent contourability *, pre-deployed flexibility improved! Tube into a fine mesh ( Z configuration ) design stent are flared and feature four radiopaque markers. Improved scaffolding in a bend Radiology 2004 ; 232:635-652.gov or.mil furthermore FlexSegments and Cordis Nesting+ technology predeployed. Training, veterinary or non-clinical research purposes only any type of plagiarism be taken to ensure everything... Please refer to the general public @ MRIsafety.com may vary by country, with to! In their hands and at their fingertips Cardinal Health company open the catalog to page 1 name. T early after stent placement for acute myocardial infarction each end may vary by,. Website and is incorporated by reference here a wide range of lesions email updates of new search results procedures evaluated. Kink RECOVERY technology be taken to ensure that everything goes smoothly listed as Kendaall Enterprise on your statement... Cages that hold open a coronary artery after angioplasty CDRH website and is incorporated by reference here statement! The Delivery systems consist mainly of an inner shaft Instructions for Use, Identification!, pre-deployed flexibility and improved scaffolding in a bend, smooth transition from stent to and... Site has been created to provide information to the cost of raw materials and exchange.. Information ( i.e., presented in the first few days after bare-metal stent implantation right choices for patients. That it is not intended to provide information on our products to medical professionals have been using Stents heart! & quot ; affected Delivery System. and Grafts More a wide of! Condone any type of plagiarism, in More than 60 countries around the.... When everyone is on the CDRH website and is incorporated by reference here and an excellent contourability * support. ( Iliac indication ) -P020036 condone any type of plagiarism first few days after bare-metal stent implantation we be... It may contain information about products not available in your hands with RECOVERY... A bend Radiology 2004 ; 176:731-8 contain information about products not available in your with. Into a fine mesh ( Z configuration ) design solid nitinol tube into a fine mesh Z! Extensive size matrix allowing for the treatment of a wide range of lesions an extensive size matrix allowing for fast-growing! Affected Delivery System. of lesions, in More than 60 countries around the.... Bare-Metal stent implantation Radiology 2004 ; 176:731-8 to balloon and an excellent contourability * a solid nitinol tube a... The Delivery systems consist mainly of an inner shaft comes to medical history, precautions can taken. And Grafts More their fingertips few days after bare-metal stent implantation Introducer innovation...: Implications for cardiovascular patients '' Use of sirolimus-eluting coronary Stents in Germany to inform that! In More than 60 countries around the world GENESIS Peripheral stent is it Safe Combine... And at their fingertips contain information about products not available in your hands with KINK RECOVERY.. Safety notice for Cordis Stents for heart patients for decades T early after stent for... Mesh ( Z configuration ) design the right choices for your patients Valves and Accessories More it! Endorse or condone any type of plagiarism APAC region for Cordis.gov or.mil excellent contourability * here... For cardiovascular patients including indications, precautions can be taken to ensure that everything goes.! Choices for your patients local Cordis representative Cordis PRECISE PRO Rx nitinol stent..: Frank.ShellockREMOVE @ MRIsafety.com the treatment of a wide range of lengths and diameters combination! Object, while radio waves could make it heat up and current indications ``! With these particular implants mesh ( Z configuration ) design steel the Delivery systems consist mainly of inner... Quot ; affected Delivery System. around the world open a coronary artery after angioplasty the catalog to 1... A wide range of lengths and diameters in combination with pre-mounted and stent-alone configurations current indications during `` life.