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1996;2(1):51-58. Permissions. With an updated browser, you will have a better Medtronic website experience. AccessGUDID - DEVICE: Open Pivot (00643169078109) Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Healthcare Professionals Five-year follow up of the ATS mechanical heart valve. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Open Pivot Mechanical Heart Valves - Surgical Heart Valves - Medtronic Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. Update my browser now. Int J Artif Organs. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Note: Manuals can be viewed using a current version of any major internet browser. Cardiovascular Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. 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 . Safety Topic/Article: You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Indications, Safety, and Warnings - Open Pivot Aortic - Medtronic You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Int J Artif Organs. Your Acknowledgements. Open Pivot Mechanical Heart Valve - Medtronic Limitations of Liability. 25 November 2022 0 Comments. Open Pivot Mechanical Heart Valves - Surgical Heart Valves | Medtronic 2000;69:507-512. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. F 708.478.3519. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. THE List - MRI Safety Home Heart Valves and Annuloplasty Rings More. Emery RW, Van Nooten GJ, Tesar PJ. Home 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. You shall at all times use the Licensed Software in compliance with all applicable laws. 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. Heart Valves and Annuloplasty Rings More. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) Click Continue to close this window and view the sites content. 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 Open Pivot Heart Valve Instructions for Use. 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. Ann Thorac Surg. Open Pivot valves are remarkably quiet.7,10. 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. Cardiovascular Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. When im-planted in the aortic position there were only . Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Premarket Approval (PMA). 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. Emery RW, Van Nooten GJ, Tesar PJ. Important Labeling Information for United States. Update my browser now. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 2009;18(4):445-452. Five-year follow up of the ATS mechanical heart valve. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Ann Thorac Surg. 2006; 33: 154-159. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Therapies & Procedures 3: . For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Clinical results of a large series of ATS valve implants. . Indications, Safety, and Warnings. 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. Update my browser now. 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. Please consult the approved indications for use. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Masters Mitral and Aortic Mechanical Valves | Abbott LifeLine CardioVascular 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. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Emery RW, Petersen RJ, Kersten TE, et al. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Disclaimer: This page may include information about products that may not be available in your region or country. 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. Surgical Heart Valve Repair and Replacement You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Reporting Issues and Feedback. Eur J Cardiothorac Surg. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. March 2004;13(2):231-238. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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. Indications, Safety, & Warnings. Update my browser now. November 1999;22(11):754-763. Warnings/Precautions/Adverse Events 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. Session Key. Ann Thorac Cardiovasc Surg. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Heart Valves Surgical Single-plane orifice facilitates valve seating and implant regardless of suture technique. 2001;4(4):346-352. Shiono M, Sezai Y, Sezai A, et al. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Sezai A, Hata M, Niino T, et al. With an updated browser, you will have a better Medtronic website experience. 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. Heart Valves Surgical 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.