With an updated browser, you will have a better Medtronic website experience. 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). If you continue, you will leave this site and go to a site run by someone else. Products 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. Technical Support. Indications for Use The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, or malfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. Heart Valves Surgical Shiono M, Sezai Y, Sezai A, et al. With an updated browser, you will have a better Medtronic website experience. Update my browser now. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. You just clicked a link to go to another website. 6-8 Outstanding Durability Advancing the Technology of Bileaflet Mechanical HeartValves. Five-year follow up of the ATS mechanical heart valve. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. 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. (4) Hassler M, et al. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. In: Krian A, Matloff JM, Nicoloff DM, eds. Sezai A, Shiono M, Orime Y, et al. Five-year follow up of the ATS mechanical heart valve. 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. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. Home A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Open Pivot valves are remarkably quiet.7,10. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Your Acknowledgements. 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. Heart Valve Replacement - Surgical A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 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. 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. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Limitations of Liability. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Disclaimer: This page may include information about products that may not be available in your region or country. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Aortic Valved Graft (AVG), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. P 844-SUTURES (788-8737) P 888.416.2409. 1.5, 3: Your Personal Information. 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: Krian A, Matloff JM, Nicoloff DM, eds. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Note: Manuals can be viewed using a current version of any major internet browser. LifeLine CardioVascular 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. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Note: Manuals can be viewed using a current version of any major internet browser. Sezai A, Shiono M, Orime Y, et al. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic 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. 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. Ann Thorac Surg. 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. This device may be used to replace a previously implanted prosthetic heart valve or conduit. Note: Manuals can be viewed using a current version of any major internet browser. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Indications, Safety, and Warnings - Medtronic U.S. Food & Drug Administration. Int J Artif Organs. 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. ) When im-planted in the aortic position there were only . Single-plane orifice facilitates valve seating and implant regardless of suture technique. MRI Resources | Medtronic A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. 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, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Emery RW, Krogh CC, Jones DJ, et al. Premarket Approval (PMA). Update my browser now. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Click OK to confirm you are a Healthcare Professional. Healthcare Professionals 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. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft Logging of Session Activity. Krian A. Fifteen years of experience with ATS mechanical heart valve prostheses. Warnings/Precautions/Adverse Events For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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). THE List - MRI Safety Home Washington D.C.: U.S. Food and Drug Administration; 2000. 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. Update my browser now. 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 2009;18(4):445-452. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Healthcare Professionals Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Open Pivot Aortic Valved Graft - Surgical Heart Valves | Medtronic Except as expressly provided herein, no person or entity other than Medtronic and you, including without limitation any patient, is or shall be a third party beneficiary of this Agreement or otherwise entitled to bring any action to enforce any provision of this Agreement against Medtronic or you. Therapies & Procedures 2006; 33: 154-159. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Five-year follow up of the ATS mechanical heart valve. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 3: Conditional 5 More. Ann Thorac Surg. Krian A. 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. You shall at all times use the Licensed Software in compliance with all applicable laws. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Healthcare Professionals Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Important Labeling Information for United States. 2003;75(2):444-452. Products Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. J Heart Valve Dis. 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. The user name and password are personal to you and must not be shared with anyone else. Permissions. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 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. Clinical results of a large series of ATS valve implants. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 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. Important Safety Information. Emery RW, Petersen RJ, Kersten TE, et al. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Van Nooten GJ, Caes F, Francois K, et al. Note: Manuals can be viewed using a current version of any major internet browser. Clinical results of a large series of ATS valve implants. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. With an updated browser, you will have a better Medtronic website experience. Masters Mitral and Aortic Mechanical Valves | Abbott Single-plane orifice facilitates valve seating and implant regardless of suture technique. New York: Springer Verlag; 1998:53-71. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Cardiovascular Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Heart Valves Surgical Int J Artif Organs. 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. The leaflets are made of solid pyrolytic carbon with a thin titanium band. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Emery RW, Petersen RJ, Kersten TE, et al. Update my browser now.

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