The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. 2006; 33: 154-159. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. With an updated browser, you will have a better Medtronic website experience. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . 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. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While 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.7,8. Premarket Approval (PMA). on x prosthetic heart valve ascending aortic proth. 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. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Update my browser now. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. 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. Eur J Cardio-thorac Surg. Accessed April 20, 2021. J Heart Valve Dis. LifeLine CardioVascular 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. Note: Manuals can be viewed using a current version of any major internet browser. Healthcare Professionals Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Medtronic Open Pivot Heart Valve Instructions for Use. Heart Valves Surgical Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Accessed April 20, 2021. 6-8 Outstanding Durability Your use of the other site is subject to the terms of use and privacy statement on that site. J Vasc Surg. 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. 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. ) Healthcare Professionals Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 3: Conditional 5 More. Technical Support. Therapies & Procedures Home J Heart Valve Dis. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 2001;4(4):346-352. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 1999; 22:754-763. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 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. The adverse events potentially associated with the use of prosthetic aortic heart 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. With an updated browser, you will have a better Medtronic website experience. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve 2009;18(4):445-452. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Indications, Safety, & Warnings. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. New York: Springer Verlag; 1998:53-71. 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. Advancing the Technology of Bileaflet Mechanical HeartValves. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Healthcare Professionals The content may not be approved for use in your specific region or country. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. More than 140,000 valves have been implanted worldwide. 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 . Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. U.S. Food & Drug Administration. In: Krian A, Matloff JM, Nicoloff DM, eds. The valve itself was correctly labeled as Mitral. In the event that any provision of this Agreement violates any applicable statute, ordinance, or rule of law, such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. March 2004;13(2):231-238. Your use of the other site is subject to the terms of use and privacy statement on that site. 2001; 4(4):346-353. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Krian A. Cardiovascular Term, Termination, Modifications, and Support. 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 You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. CAUTION: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 valves with the option of aortic root replacement. 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. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 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. Note: Manuals can be viewed using a current version of any major internet browser. It is possible that some of the products on the other site are not approved in your country. 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 unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. The initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. Eur J Cardiothorac Surg. Healthcare Professionals 2004 Mar;13(2):231-238. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. November 1999;22(11):754-763. Ann Thorac Cardiovasc Surg. Accessed April 20, 2021. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. Ann Thorac Surg. Products Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 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. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. 1996;10(8):660-665.
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