Important Labeling Information for United States. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 1996;6: 273-79. Heart Valves Surgical 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. 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. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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 site is Exclusively Sponsored by BRACCO. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. November 1999;22(11):754-763. Products For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Miscellaneous. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. U.S. Food & Drug Administration. Disclaimer: This page may include information about products that may not be available in your region or country. With an updated browser, you will have a better Medtronic website experience. Technical Support. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Accessed April 20, 2021. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. 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. 1996;2(1):51-58. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Ann Thorac Cardiovasc Surg. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Open Pivot Aortic Valved Graft. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Emery RW, Petersen RJ, Kersten TE, et al. Int J Artif Organs. By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User: ) Registration. Availability. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Fifteen years of experience with ATS mechanical heart valve prostheses. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. In addition, upon Medtronics request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction. By installing or using the Licensed Software to view the Programmer screen information, registering a username and password in connection with the Medtronic RemoteView feature, or clicking on any acceptance button in connection herewith, you, a Remote Viewer, agree to be bound by all of the terms and conditions set forth in these Terms of Use (this Agreement). Limited License Grant. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, infection other than endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. 2,9,10 Clinical results of a large series of ATS valve implants. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Term, Termination, Modifications, and Support. J Thorac Cardiovasc Surg. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. September 1993;106(3):427-433. Heart Surg Forum. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. 1996(10):660-665. 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. 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 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. MeSH terms Adolescent Adult Aged Aorta / surgery* J Heart Valve Dis. March 2004;13(2):231-238. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Sezai A, Shiono M, Orime Y, et al. Permissions. 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. Ann Thorac Surg. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. The Suture Superstore that provides surgical disposables, sutures & more. The reoperation rate was 1.2%. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Products Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Indications, Safety, & Warnings. Please consult the approved indications for use. Indications, Safety, & Warnings. 1996;10(8):660-665. 2003;75(2):444-452. When im-planted in the aortic position there were only . 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%. Emery RW, Krogh CC, Jones DJ, et al. All information that you provide in connection with such registration must be complete, accurate, and truthful. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Indications, Safety, and Warnings. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. LifeLine CardioVascular Potential Adverse Events: Certain complications may occur with heart valve procedures. J Heart Valve Dis. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Surgical Heart Valve Repair and Replacement Heart Surgery Forum. Tex Heart Inst J. Heart Surg Forum. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Clinical results of a large series of ATS valve implants. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Shiono M, Sezai Y, Sezai A, et al. 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 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. Session Key. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. LifeLine CardioVascular For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Ann Thorac Cardiovasc Surg. 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. With an updated browser, you will have a better Medtronic website experience. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Your use of the other site is subject to the terms of use and privacy statement on that site. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. . 2000;69:507-512. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Van Nooten GJ, Caes F, Francois K, et al. MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Ln N Plymouth MN 55447-5439: Manufacturer Reason for Recall: Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. J Radiol 1986;67:661-666. Cardiovascular Advanced Discussion (show/hide) References Note: Manuals can be viewed using a current version of any major internet browser. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America. ) Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. However, further studies are required to determine the effect of valve gradient on survival. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. Ann Thorac Cardiovasc Surg. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, ormalfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. J Heart Valve Dis. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. 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. Home Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. The Medtronic Open Pivot AP360, AP, and Standard valves provide exceptional implantability, performance, and durability.1-3, Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Emery RW, Petersen RJ, Kersten TE, et al. With an updated browser, you will have a better Medtronic website experience. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. In: Krian A, Matloff JM, Nicoloff DM, eds. Open Pivot Mechanical Heart Valves.
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