Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71.
Heart Surgery Forum. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU FOR INTERCEPTION OR COMPROMISE OF ANY INFORMATION OR FOR ANY RECORD OR OTHER COMMUNICATION PROVIDED IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE. This device may be used to replace a previously implanted prosthetic heart valve or conduit.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
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.
Ann Thorac Cardiovasc Surg. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. In: Krian A, Matloff JM, Nicoloff DM, eds. Heart Valves Surgical
Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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).
In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with 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.
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Early results. Indications, Safety, & Warnings. 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. Medtronic Open Pivot Heart Valves Product Specifications medtronic open pivot Standard Heart valve Aortic Standard Tissue Annulus Orifice Inner Geometric Valve Size Model Diameter (B) Diameter (A) Orifice Area (mm) Number (mm) (mm) (cm2) 19 500FA19 19.5 14.8 1.55 21 500FA21 21.5 16.8 2.02 23 500FA23 23.5 18.8 2.56 Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. It is possible that some of the products on the other site are not approved in your country. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic.
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THE List - MRI Safety Home Ann Thorac Cardiovasc Surg.
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 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. 2001;4(4):346-352.
Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic 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. 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. Click OK to confirm you are a Healthcare Professional.
Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. 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.
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. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Patients
A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. J Vasc Surg. 1999; 22:754-763. 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.
ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Clinical results of a large series of ATS valve implants. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. March 2004;13(2):231-238.
Open Pivot Mechanical Heart Valve - Medtronic
2,3 . Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions.
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
Fifteen years of experience with ATS mechanical heart valve - PubMed Van Nooten GJ, Caes F, Francois K, et al. Open Pivot Mechanical Heart Valve.
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. P 844-SUTURES (788-8737) P 888.416.2409. Healthcare Professionals
FDA Determined Cause 2: Labeling mix-ups . No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories 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 ].
Update my browser now. Medtronic open pivot mechanical valves offer exceptional performance: Remarkable thromboresistance: Continuous passive washing provides for gentle treatment of blood cells and low levels of hemolysis and thromboembolic events. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Accessed April 20, 2021.
Premarket Approval (PMA) - Food and Drug Administration 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.
THE List - MRI Safety
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.
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.
1996;10(8):660-665.
Advanced Discussion (show/hide) References In: Krian A, Matloff JM, Nicoloff DM, eds.
Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. 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. Emery RW, Petersen RJ, Kersten TE, et al.
MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation.
Legal Compliance. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name.
2004 Mar;13(2):231-238. 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 aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Heart Surg Forum. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com.
Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Krian A.
The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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). Update my browser now.
Fifteen years single-center experience with the ATS bileaflet valve.
The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. 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. 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. Clinical results of a large series of ATS valve implants.
For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 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 Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use.
J Heart Valve Dis.
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. 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.
Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Note: Manuals can be viewed using a current version of any major internet browser. Washington D.C.: U.S. Food and Drug Administration; 2000. Five-year follow up of the ATS mechanical heart valve. 2009;18(4):445-452. Cardiovascular Warnings/Precautions/Adverse Events Email:
[email protected] CLOSE . All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Healthcare Professionals J Thorac Cardiovasc Surg. 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.
Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. This site is Exclusively Sponsored by BRACCO. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 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.
The initial United States experience with the ATS mechanical cardiac valve prosthesis. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan.
With an updated browser, you will have a better Medtronic website experience. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Int J Artif Organs.
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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. Reproduced with permission from Medtronic, Inc. View Media Gallery Replacement of diseased valves with prosthetic heart valves reduces the morbidity and mortality associated with native. The reoperation rate was 1.2%. 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.
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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Cardiovascular 3: .
Heart Valves Surgical Open Pivot Mechanical Heart Valves. 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. This Agreement shall be in effect from the date when you first install or use the Licensed Software. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Medtronic Open Pivot Heart Valve Instructions for Use. Advancing the Technology of Bileaflet Mechanical HeartValves.
Premarket Approval (PMA) 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%. New York: Springer Verlag; 1998:53-71.
If not approved, please exit this site. Clinical results of a large series of ATS valve implants. Int J Artif Organs. Eur J Radiol 1992;2:555-558. 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. With an updated browser, you will have a better Medtronic website experience.
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.
1.5, 3: When im-planted in the aortic position there were only .
Heart Valves and Annuloplasty Rings More. Products Note: Manuals can be viewed using a current version of any major internet browser.
U.S. Food & Drug Administration. Eur J Cardiothorac Surg. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Update my browser now.
Emery RW, Van Nooten GJ, Tesar PJ. Open Pivot Mechanical Heart Valves.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Medtronic Open Pivot Heart Valve Instructions for Use. 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.
Krian A.
Ats Medical Heart Valve Mri Safety | Day of Difference New York: Springer Verlag; 1998:53-71. 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. Even very old stainless steel valves are likewise considered of no danger in MRI.
Heart Valve Replacement - Surgical
Open Pivot Aortic Valved Graft - Surgical Heart Valves | Medtronic Sezai A, Shiono M, Orime Y, et al.
Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Your use of the other site is subject to the terms of use and privacy statement on that site. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement.
Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.