medtronic open pivot heart valve mri safety

Warnings/Precautions/Adverse Events With an updated browser, you will have a better Medtronic website experience. Medtronic Open Pivot Heart Valve Instructions for Use. J Thorac Cardiovasc Surg. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. 2001;4(4):346-352. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Please review applicable product labeling for your country for indications and instructions prior to use. Ann Thorac Surg. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. MeSH terms Adolescent Adult Aged Aorta / surgery* 1996;10(8):660-665. 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. 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. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Open Pivot valves are remarkably quiet.7,10. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Proven Graft Material All information that you provide in connection with such registration must be complete, accurate, and truthful. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. March 1993;17(3):538-545. 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 . 2003;75(2):444-452. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. 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. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: J Heart Valve Dis. Fifteen years single-center experience with the ATS bileaflet valve. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. If you continue, you will leave this site and go to a site run by someone else. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) 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. Van Nooten GJ, Caes F, Francois K, et al. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. Note: Manuals can be viewed using a current version of any major internet browser. 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. 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 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. J Thorac Cardiovasc Surg. Atriasept Closure DeviceCardia, Inc.Eagan, MN, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., Lake Forrest, CA, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., www.navigatecsi.com, Atrix-C Cervical Allograft Interbody SpacerXtant Medical, www.xtantmedical.com, Atrostim Phrenic Nerve StimulatorASTROTECH OYTampere, Finland, ATS 3f Enable Aortic BioprosthesisModel 6000ATS Medical, Inc.Lake Forest, CA, ATS Medical Open PivotAortic Valved GraftModel # XX denotes size502AGxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAortic, Model 501DA18Advanced Performance (AP)pyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 AorticModel # XX denotes size505DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 MitralModel # XX denotes size505DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP AorticModel # XX denotes size501DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP MitralModel # XX denotes size501DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex AorticModel # XX denotes size503DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex MitralModel # XX denotes size503DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveMitral, Model 500DM29Standard Valvepyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard AorticModel # XX denotes size500FAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard MitralModel # XX denotes size500DMxxATS MedicalMinneapolis, M, ATTRACTOR Screw17-4 SSPorex Surgical, Newnan, GA, Attune Flexible Annuloplasty RingSt. Home Your Personal Information. Open Pivot valves are remarkably quiet.7,10. 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 U.S. Food & Drug Administration. P 844-SUTURES (788-8737) P 888.416.2409. Fifteen years single-center experience with the ATS bileaflet valve. 1996;2(1):51-58. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Note: Manuals can be viewed using a current version of any major internet browser. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. 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). Session Key. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Cell Mater. With an updated browser, you will have a better Medtronic website experience. Home The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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. 1996;10(8):660-665. J Radiol 1986;67:661-666. On-X Life Technologies, Inc. P000037 S059: 03/24/2022: 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. Washington D.C.: U.S. Food and Drug Administration; 2000. Term, Termination, Modifications, and Support. Miscellaneous. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Phone Numbers. 6-8 Outstanding Durability Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Accessed April 20, 2021. 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). Patients Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 2000;69:507-512. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While 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.7,8. It is possible that some of the products on the other site are not approved in your country. Home November 1999;22(11):754-763. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Ann Thorac Cardiovasc Surg. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Medtronic Open Pivot Heart Valve Instructions for Use. More than 140,000 valves have been implanted worldwide. J Heart Valve Dis. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Important Safety Information. Heart Valves Surgical The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Emery RW, Petersen RJ, Kersten TE, et al. 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, Van Nooten GJ, Tesar PJ. 2001;4(4):346-352. Heart Valves Surgical With an updated browser, you will have a better Medtronic website experience. Cardiovascular 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. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories The initial United States experience with the ATS mechanical cardiac valve prosthesis. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Your use of the other site is subject to the terms of use and privacy statement on that site. LifeLine CardioVascular 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. Note: Manuals can be viewed using a current version of any major internet browser. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Potential Adverse Events: Certain complications may occur with heart valve procedures. 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). Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for Aortic Valve and Ascending Aorta Replacement, 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. New York: Springer Verlag; 1998:53-71. Update my browser now. Van Nooten GJ, Caes F, Francois K, et al. 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. ) Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. With an updated browser, you will have a better Medtronic website experience. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Medtronic Open Pivot Mechanical Valves Offer Exceptional Performance Remarkable Thromboresistance Continuous passive washing provides for gentle treatment of blood cells and low levels Excellent Hemodynamics In-vivo studies demonstrates improved hemodynamic performance following device implant. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve FDA Determined Cause 2: Labeling mix-ups . 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. Eur J Cardiothorac Surg. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Eur J Cardiothorac Surg. Home 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. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. Healthcare Professionals 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. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Availability. Legal Compliance. It is possible that some of the products on the other site are not approved in your region or country. 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). When im-planted in the aortic position there were only . The initial United States experience with the ATS mechanical cardiac valve prosthesis. Safety Topic / Subject Article Text 179: . For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. In: Krian A, Matloff JM, Nicoloff DM, eds. Healthcare Professionals Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Active Remote Users. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. The content may not be approved for use in your specific region or country. 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. J Heart Valve Dis. Ann Thorac Surg. New York: Springer Verlag; 1998:53-71. Reporting Issues and Feedback. Email: Corporate.UDI@medtronic.com CLOSE . The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. 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. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. 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. Medtronic Open Pivot Aortic Valved Graft (AVG) for Aortic Valve and Ascending Aorta Replacement The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Open Pivot Mechanical Heart 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. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Heart Surg Forum. 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 Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Treatments & Therapies The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Cardiovascular Cardiovascular With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. 3: . Indications, Safety, & Warnings. 2009;18(4):445-452. The reoperation rate was 1.2%. Krian A. Update my browser now. Cardiovascular Indications, Safety, & Warnings. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. 1996;10(8):660-665. Five-year follow up of the ATS mechanical heart valve. Heart Valves Surgical 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. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Five-year follow up of the ATS mechanical heart valve. 2009;18(4):445-452. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. March 2004;13(2):231-238. J Heart Valve Dis. Open Pivot Mechanical Heart Valves. 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.

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