Cardiovascular With an updated browser, you will have a better Medtronic website experience. 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. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. Shiono M, Sezai Y, Sezai A, et al. Emery RW, Krogh CC, Jones DJ, et al. J Heart Valve Dis. New York: Springer Verlag; 1998:53-71. The initial United States experience with the ATS mechanical cardiac valve prosthesis. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. More R and Haubold A. 2,9,10 Eur J Cardiothorac Surg. Security/Privacy of Patient Data. 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. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. This site is Exclusively Sponsored by BRACCO. Note: Manuals can be viewed using a current version of any major internet browser. Shiono M, Sezai Y, Sezai A, et al. 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. September 1993;106(3):427-433. Permissions. 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 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. Phone Numbers. Eur J Cardiothorac Surg. More than 140,000 valves have been implanted worldwide. Session Key. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. In: Krian A, Matloff JM, Nicoloff DM, eds. Home Surface chemistry and surface roughness of clinical pyrocarbons. 1996;10(8):660-665. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Even very old stainless steel valves are likewise considered of no danger in MRI. Five-year follow up of the ATS mechanical heart valve. Home It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Note: Manuals can be viewed using a current version of any major internet browser. Update my browser now. J Heart Valve Dis. P 844-SUTURES (788-8737) P 888.416.2409. Clinical results of a large series of ATS valve implants. Home 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. LifeLine CardioVascular Fifteen years of experience with ATS mechanical heart valve prostheses. With an updated browser, you will have a better Medtronic website experience. Open Pivot Mechanical Heart Valves. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Products Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement, Medtronic Open Pivot Aortic Valved Graft, 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. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 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. Heart Valves Surgical Cardiovascular Ann Thorac Surg. 2,3 . A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma. With an updated browser, you will have a better Medtronic website experience. Contraindications: None known . 2009;18(4):445-452. Emery RW, Van Nooten GJ, Tesar PJ. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. 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 Update my browser now. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories 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. ) March 2004;13(2):231-238. 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. Washington D.C.: U.S. Food and Drug Administration; 2000. 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. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. Brand Name: Open Pivot Version or Model: 500FA23 Commercial Distribution Status: Not in Commercial Distribution Catalog Number: Company Name: MEDTRONIC, INC. Primary DI Number: 00613994960412 Issuing Agency: GS1 Commercial Distribution End Date: October 21, 2019 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use Cardiovascular 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%. Home Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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. Indications, Safety, and Warnings. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Heart Valve Replacement - Surgical Important Safety Information. 2001;4(4):346-352. Emery RW, Petersen RJ, Kersten TE, et al. Patients 2001;4(4):346-352. With an updated browser, you will have a better Medtronic website experience. Please review applicable product labeling for your country for indications and instructions prior to use. 1996; 2(1):51-58. Indications, Safety, & Warnings. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. 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. Van Nooten GJ, Caes F, Francois K, et al. 1996;10(8):660-665. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The user name and password are personal to you and must not be shared with anyone else. 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. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 2009;18(4):445-452. 2003;75(2):444-452. 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 The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Availability. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. November 1999;22(11):754-763. 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. Home 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. Five-year follow up of the ATS mechanical heart valve. Products Note: Manuals can be viewed using a current version of any major internet browser. Emery RW, Petersen RJ, Kersten TE, et al. Ann Thorac Cardiovasc Surg. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. Heart Surg Forum. Update my browser now. Miscellaneous. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Int J Artif Organs. Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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. Technical Support. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Adverse events can include: angina, cardiac dysrhythmias, death, endocarditis, heart failure, hemolytic anemia, infection other than endocarditis, myocardial infarction, root dilatation, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Potential Adverse Events: 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. Note: Manuals can be viewed using a current version of any major internet browser. Fifteen years single-center experience with the ATS bileaflet valve. 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. 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. Ann Thorac Surg. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Open Pivot Mechanical Heart Valves. MRI Resources, For clinicians whose patients have a Medtronic system. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Home 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. 1996;10(8):660-665. LifeLine CardioVascular Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Five-year follow up of the ATS mechanical heart valve. The Suture Superstore that provides surgical disposables, sutures & more. Ann Thorac Surg. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 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. 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.
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