September 1993;106(3):427-433. Note: Manuals can be viewed using a current version of any major internet browser. 2000;69:507-512. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 2003;75(2):444-452. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Products This Agreement shall be governed by and interpreted, construed, and enforced in accordance with the laws of the State of Minnesota (exclusive of the choice of law rules thereof). 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. Cardiovascular A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Session Key. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Products Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Update my browser now. More R and Haubold A. Technical Support. Heart Valves Surgical Ann Thorac Surg. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. 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 . Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. 2,9,10 Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. , chronic renal failure, hyperparathyroidism). 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. Open Pivot valves are remarkably quiet.7,10. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Emery RW, Van Nooten GJ, Tesar PJ. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. 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. Important Labeling Information for United States. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Sezai A, Shiono M, Orime Y, et al. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information. ) Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Emery RW, Petersen RJ, Kersten TE, et al. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. New York: Springer Verlag; 1998:53-71. LifeLine CardioVascular March 2004;13(2):231-238. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. Van Nooten GJ, Caes F, Francois K, et al. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Shiono M, Sezai Y, Sezai A, et al. 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 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. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. This device may be used to replace a previously implanted prosthetic heart valve or conduit. 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. Miscellaneous. In: Krian A, Matloff JM, Nicoloff DM, eds. If not approved, please exit this site. Term, Termination, Modifications, and Support. Healthcare Professionals Int J Artif Organs. Five-year follow up of the ATS mechanical heart valve. Aortic and Mitral Valve Replacement March 2004;13(2):231-238. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. Legal Compliance. Cardiovascular Therapies & Procedures 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 ]. 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. 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. Ann Thorac Surg. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Note: Manuals can be viewed using a current version of any major internet browser. 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 2001;4(4):346-352. You just clicked a link to go to another website. Cell Mater. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Certain complications may occur with heart valve procedures. 2001;4(4):346-352. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Five-year follow up of the ATS mechanical heart valve. Click OK to confirm you are a Healthcare Professional. 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. Eur J Cardio-thorac Surg. . Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Washington D.C.: U.S. Food and Drug Administration; 2000. Ann Thorac Surg. Update my browser now. 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. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Indications, Safety, & Warnings. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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). Eur J Cardiothorac Surg. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. 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.
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