medtronic open pivot heart valve mri safety

Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Eur J Cardio-thorac Surg. J Heart Valve Dis. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Five-year follow up of the ATS mechanical heart valve. Premarket Approval (PMA). Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. LifeLine CardioVascular 2001;4(4):346-352. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 1996(10):660-665. Cardiovascular 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. 2000;69:507-512. Miscellaneous. In the event that any provision of this Agreement violates any applicable statute, ordinance, or rule of law, such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. November 1999;22(11):754-763. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 2009;18(4):445-452. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 2009;18(4):445-452. Potential Adverse Events: Certain complications may occur with heart valve procedures. Medtronic Open Pivot Aortic Valved Graft (AVG) 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. Five-year follow up of the ATS mechanical heart valve. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Cardiac Surgery Education, Innovation, and Evidence, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 to 26 mm for aortic 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. Reporting Issues and Feedback. 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. Products 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. Cardiovascular Healthcare Professionals A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Limitations of Liability. Indications, Safety, & Warnings. 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. 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. ) Home AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Update my browser now. Home Heart Valves Surgical Legal Compliance. Emery RW, Petersen RJ, Kersten TE, et al. Phone Numbers. Update my browser now. 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. U.S. Food & Drug Administration. March 2004;13(2):231-238. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Heart Valves and Annuloplasty Rings More. Fifteen years single-center experience with the ATS bileaflet valve. Int J Artif Organs. Van Nooten GJ, Caes F, Francois K, et al. Therapies & Procedures Sezai A, Hata M, Niino T, et al. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Update my browser now. LifeLine CardioVascular 6-8 Outstanding Durability All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. 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. With an updated browser, you will have a better Medtronic website experience. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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. With an updated browser, you will have a better Medtronic website experience. Krian A. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. Heart Valves Surgical 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. Shiono M, Sezai Y, Sezai A, et al. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 2001;4(4):346-352. Eur J Cardiothorac Surg. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Tex Heart Inst J. J Thorac Cardiovasc Surg. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Shiono M, Sezai Y, Sezai A, et al. Availability. Term, Termination, Modifications, and Support. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Products You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Int J Artif Organs. Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) 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. 1996;10(8):660-665. Medtronic, Inc. ("Medtronic") offers RemoteView, which permits a user ("Programmer User") of the Medtronic CareLink2090 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 Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Update my browser now. LifeLine CardioVascular Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Heart Valves Surgical Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU OR YOUR ASSOCIATED HOSPITAL, CLINIC, OR PRACTICE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE, SESSIONS KEYS, OR THESE TERMS OF USE (WHETHER IN WARRANTY, CONTRACT, TORT, OR OTHERWISE, INCLUDING NEGLIGENCE, AND EVEN IF MEDTRONIC HAS BEEN ADVISED OF THE POSSIBILITY THEREOF), INCLUDING WITHOUT LIMITATION MEDICAL EXPENSES, LOSS OF REVENUE OR PROFITS, OR DAMAGES RESULTING FROM LOSS, MISAPPROPRIATION, OR UNAUTHORIZED OR MALICIOUS ACCESS TO OR MODIFICATION OF DEVICE DATA, OR FROM MISTAKES, OMISSIONS, OR DELAYS IN TRANSMISSION OF INFORMATION, OR FROM INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS, VIRUSES OR FAILURES OF PERFORMANCE, OR FROM THE IMPACT OF THE USE ON YOUR SYSTEM. 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. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. J Heart Valve Dis. Thus at present, most centers consider all implanted heart valves and annuloplasty rings conditionally safe for MR imaging up to 3.0T, and do not require any waiting period after surgery before they can be scanned. Int J Artif Organs. 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. Important Safety Information. Krian A. U.S. Food & Drug Administration. Limited License Grant. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Eur J Cardiothorac Surg. The content may not be approved for use in your specific region or country. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Krian A. J Heart Valve Dis. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Five-year follow up of the ATS mechanical heart valve. 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. With an updated browser, you will have a better Medtronic website experience. Int J Artif Organs. Indications, Safety, and Warnings. Your Acknowledgements. 2003;75(2):444-452. Disclaimer: This page may include information about products that may not be available in your region or country. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Update my browser now. 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. In: Krian A, Matloff JM, Nicoloff DM, eds. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. MEDTRONIC ATS MEDICAL, INC. P990046 S065: 10/21/2022: open pivot heart valve, open pivot aortic valved g. MEDTRONIC ATS MEDICAL, INC. P990046 S064: 03/10/2022: medtronic open pivot heart valve, medtronic open p. MEDTRONIC ATS MEDICAL, INC. P990046 S063: 03/11/2022: open pivot mechanical valve (ophv), open pivot aor. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. November 1999;22(11):754-763. September 1993;106(3):427-433. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Healthcare Professionals Early results. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Indications, Safety, & Warnings. FDA Determined Cause 2: Labeling mix-ups . ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. data, and the Medtronic valves are no exception. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. Please review applicable product labeling for your country for indications and instructions prior to use. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. 1996;10(8):660-665. Sezai A, Shiono M, Orime Y, et al. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Accelerated structural 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, or hyperparathyroidism). You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. Update my browser now. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Healthcare Professionals Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Ann Thorac Surg. Update my browser now. 1999; 22:754-763. New York: Springer Verlag; 1998:53-71. Low target-INR anticoagulation is safe in selected aortic valve patients with the Medtronic Open Pivot mechanical prosthesis: Long-term results of a propensity-matched comparison with standard. If not approved, please exit this site. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. 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. Emery RW, Van Nooten GJ, Tesar PJ. Accessed April 20, 2021. Potential Adverse Events: Certain complications may occur with heart valve procedures. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Products LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Mechanical Heart Valves, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. In: Krian A, Matloff JM, Nicoloff DM, eds. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. MeSH terms Adolescent Adult Aged Aorta / surgery* March 1993;17(3):538-545. With an updated browser, you will have a better Medtronic website experience. You just clicked a link to go to another website. 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%. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Heart Valves and Annuloplasty Rings More. Emery RW, Krogh CC, Jones DJ, et al. Heart Surg Forum. J Thorac Cardiovasc Surg. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Security/Privacy of Patient Data. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Safety Topic / Subject Article Text 179: . At any time upon Medtronics request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. This site is Exclusively Sponsored by BRACCO. 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. Open Pivot Mechanical Heart Valves. These improvements led to low thromboembolic rates of 1.25% per patient year and encouraged a reduction in anticoagulation treatment to an INR of 1.5 to 2.5 in isolated aortic valve replacement cases [ 179 ]. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Technical Support. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Accelerated structural 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, or hyperparathyroidism). 2010;139:1494-1500. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. 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. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Cardiovascular Products Surgical Heart Valve Repair and Replacement Healthcare Professionals The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. Note: Manuals can be viewed using a current version of any major internet browser. J Heart Valve Dis. Open Pivot Mechanical Heart Valve. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Technical Support. Logging of Session Activity. If you continue, you may go to a site run by someone else. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Van Nooten GJ, Caes F, Francois K, et al. Clinical results of a large series of ATS valve implants. Healthcare Professionals Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.