Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Healthcare Professionals Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Heart Valve Replacement - Surgical For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. U.S. Food & Drug Administration. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Ann Thorac Surg. Medtronic open pivot mechanical valves offer exceptional performance: The Open Pivot AP360 provides these additional features: The Open Pivot AP provides these additional features: The Open Pivot Standard Aortic Valve provides these additional features: The Open Pivot Standard Mitral Valve provides these additional features: A variety of accessories are available to quickly and easily select the optimal valve type, appropriate valve size, and ideal placement for valve positioning. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Mitral bi-leaflet mechanical heart valve prosthesis An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. Home We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. This Agreement constitutes the entire agreement between Medtronic and you regarding your use of the Licensed Software and supersedes any prior and contemporaneous written or oral agreements or understandings related to the Licensed Software. Early results. J Heart Valve Dis. Active Remote Viewer as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. More than 140,000 valves have been implanted worldwide. 25 November 2022 0 Comments. With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Products This device may be used to replace a previously implanted prosthetic heart valve or conduit. In: Krian A, Matloff JM, Nicoloff DM, eds. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Heart Valves Surgical FDA Determined Cause 2: Labeling mix-ups . Sezai A, Shiono M, Orime Y, et al. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. J Heart Valve Dis. Heart Surgery Forum. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Premarket Approval (PMA). Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Eur J Cardiothorac Surg. Heart Valves and Annuloplasty Rings More. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Medtronic, Inc. (Medtronic) offers RemoteView, which permits a user (Programmer User) of the Medtronic CareLink 2090 Programmer (Programmer) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (Remote Viewer), including remote health care professionals or Medtronic representatives. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. Ann Thorac Surg. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Please consult the approved indications for use. The reoperation rate was 1.2%. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. 3: Conditional 5 More. THE LICENSED SOFTWARE IS PROVIDED TO YOU AS IS, AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Update my browser now. 1999; 22:754-763. Home It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Ann Thorac Surg. The Medtronic Open Pivot aortic valved graft is contraindicated in patients unable to tolerate anticoagulation therapy or who exhibit a sensitivity to polyester or materials of bovine origin. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Van Nooten GJ, Caes F, Francois K, et al. You just clicked a link to go to another website. Note: Manuals can be viewed using a current version of any major internet browser. Five-year follow up of the ATS mechanical heart valve. 2000;69:507-512. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Heart Surg Forum. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Open Pivot Mechanical Heart Valve, Medtronic Open Pivot Mechanical Heart Valves, While mechanical valves have been used for heart valve replacement for nearly 50 years, the Medtronic Open Pivot platform brings a fundamentally different design to bileaflet mechanical valves. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Healthcare Professionals Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Limited License Grant. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 1996; 2(1):51-58. Ann Thorac Cardiovasc Surg. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. 2,3 . The adverse events potentially associated with the use ofprosthetic aortic valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage,myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. The adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. Term, Termination, Modifications, and Support. . Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Ann Thorac Cardiovasc Surg. Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. Cardiovascular Medtronic Open Pivot Heart Valve Instructions for Use. March 2004;13(2):231-238. The initial United States experience with the ATS mechanical cardiac valve prosthesis. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a terrorist supporting country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Clinical results of a large series of ATS valve implants. September 1993;106(3):427-433. 3: . 2000;69:507-512. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). November 1999;22(11):754-763. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Indications: The Medtronic Open Pivot Aortic Valved Graft is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required. Please review applicable product labeling for your country for indications and instructions prior to use. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Surgical Heart Valve Repair and Replacement Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. J Radiol 1986;67:661-666. A recent publication from a single center in Belgium followed all patients with an Open Pivot valve im-planted over a 20 year period.81 In total, 1520 Open Pivot valves were implanted in 1382 consecutive patients with a 99% rate of follow-up. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. Brand Name: Medtronic Open Pivot Version or Model: 569 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC 3F THERAPEUTICS, INC. Primary DI Number: 00763000318581 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527232 * Terms of Use Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Aortic Valved Graft (AVG), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Aortic Valved Graft (AVG), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. For a Remote Viewer to view information displayed on a Programmer, the Remote Viewer needs to install or access the Bomgar Representative Console software (Licensed Software). The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Conclusion: The Medtronic Open Pivot valved conduit is a safe and durable option for aortic root replacement, and is associated with low morbidity and 10-year survival of 79%. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. LifeLine CardioVascular The adverse events potentially associated with the use ofprosthetic aortic valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage,myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. Open Pivot Aortic Valved Graft The parties hereby expressly waive any right to a trial by jury or class treatment of any claim, demand, action, or cause of action arising out of or relating to the Licensed Software or this Agreement. Note: Manuals can be viewed using a current version of any major internet browser. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. More R and Haubold A. Update my browser now. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. Medtronic may modify, disable, or terminate your use or Medtronics support of the Licensed Software at any time, including by providing notices on a Medtronic website. Emery RW, Petersen RJ, Kersten TE, et al. Home It is possible that some of the products on the other site are not approved in your country. , chronic renal failure, hyperparathyroidism). Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. Open Pivot Mechanical Heart Valves Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Treatments & Therapies AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. It is possible that some of the products on the other site are not approved in your region or country. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Clinical results of a large series of ATS valve implants. NayaMed International Srl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Srl. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Medtronic Open Pivot Aortic Valved Graft (AVG), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. Shiono M, Sezai Y, Sezai A, et al. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information. ) The Open Pivot AP360 provides these additional features: The Open Pivot Standard aortic valve provides these additional features: The Open Pivot Standard mitral valve provides these additional features: A variety of accessories are available to quickly and easily select the optimal valve type, appropriate valve size, and ideal placement for valve positioning. what happened in 1906 in europe As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in perceval sutureless heart valve: CORCYM Canada Corp. P150011 S026: 11/21/2022: exoseal vascular closure device: Cordis US Corporation: P100013 S026: 10/28/2022: vibrant soundbridge system: Med-el Elektromedizinische Ger: P990052 S026: 10/11/2022: r3 delta ceramic acetabular system: Smith & Nephew, Inc. P150030 S026: 09/21/2022: relayplus . You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Washington D.C.: U.S. Food and Drug Administration; 2000. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS 1996(10):660-665. Cardiovascular Open Pivot Mechanical Heart Valve. Central/Eastern Europe, Middle East & Africa, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement, Supra-annular compact cuff configuration for excellent suturability and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic and mitral valve replacement, Intra-annular valve with generous, compliant cuff for exceptional implantability, Medtronic Open Pivot Sizer Kit includes AP Series and Standard Heart Valve sizers, a bendable holder handle, and a sterilization tray, Mitral Hex End Rotators and Holder provide additional length and flexibility when needed for rotation of mitral valves. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 2001; 4(4):346-353. Emery RW, Van Nooten GJ, Tesar PJ. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The Suture Superstore that provides surgical disposables, sutures & more. Note: Manuals can be viewed using a current version of any major internet browser. Surface chemistry and surface roughness of clinical pyrocarbons. Eur J Cardiothorac Surg. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. If you continue, you will leave this site and go to a site run by someone else. Cardiovascular Unique axis of suspension results in leaflet movement responsive to physiological demands; Gentle, passive washing ensures complete washing of the pivot in both open and closed positions; Most patients cannot hear the sound of their valve after implantation; Low levels of hemolysis and thromboembolic events Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. J Vasc Surg. Open Pivot valves are remarkably quiet.7,10. Contraindications: None known . Click Continue to close this window and view the sites content. Advanced Discussion (show/hide) References Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Logging of Session Activity. 6-8 Outstanding Durability Update my browser now. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. With regard to any purported agreement or terms of use between you and Bomgar Corporation in connection with the Licensed Software (Bomgar EULA): (a) any Bomgar EULA shall be solely between you and Bomgar Corporation; (b) Medtronic shall not be a party to any Bomgar EULA; (c) any Bomgar EULA shall not necessarily reflect the contents of any agreement between Bomgar Corporation and Medtronic; (d) any Bomgar EULA shall not modify or take precedence over this Agreement; and (e) nothing in this Agreement shall be construed to suggest the enforceability or unenforceability of any Bomgar EULA.
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