2001;4(4):346-352. With an updated browser, you will have a better Medtronic website experience. J Thorac Cardiovasc Surg. 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. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. 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. With an updated browser, you will have a better Medtronic website experience. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 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. This device may be used to replace a previously implanted prosthetic heart valve or conduit. 2000;69:507-512. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Emery RW, Krogh CC, Jones DJ, et al. 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. 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. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Five-year follow up of the ATS mechanical heart valve. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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. If you continue, you may go to a site run by someone else. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart Valves Surgical Reporting Issues and Feedback. Treatments & Therapies 2004 Mar;13(2):231-238. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Van Nooten GJ, Caes F, Francois K, et al. More than 140,000 valves have been implanted worldwide. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS With an updated browser, you will have a better Medtronic website experience. The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. Update my browser now. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Click Continue to close this window and view the sites content. 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. ) FDA Determined Cause 2: Labeling mix-ups . November 1999;22(11):754-763. Email: Corporate.UDI@medtronic.com CLOSE . 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. Eur J Radiol 1992;2:555-558. It is possible that some of the products on the other site are not approved in your country. Note: Manuals can be viewed using a current version of any major internet browser. Cardiovascular Thus, a patient with any heart valve prosthesis listed in Table 1 undergoing an MRI procedure using an MR system operating at 1.5 T or less would not be at risk with regard to movement or dislodgement of the implant. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. New York: Springer Verlag; 1998:53-71. 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. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. J Heart Valve Dis. Phone Numbers. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Availability. Your use of the other site is subject to the terms of use and privacy statement on that site. Warnings/Precautions/Adverse Events 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 2003;75(2):444-452. 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. Heart Valves and Annuloplasty Rings More. Fifteen years single-center experience with the ATS bileaflet valve. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. Ann Thorac Cardiovasc Surg. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. 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 ]. 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. September 1993;106(3):427-433. Heart Surg Forum. This site is Exclusively Sponsored by BRACCO. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Active Remote Users. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. J Radiol 1986;67:661-666. Even very old stainless steel valves are likewise considered of no danger in MRI. Heart Surg Forum. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. At any time upon Medtronics request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. Home Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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 Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Ann Thorac Surg. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Products 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Ann Thorac Surg. You just clicked a link to go to another website. Open Pivot Mechanical Heart Valve. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 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. 2,9,10 Kelly SGD, Verdonck PR, Vierendeels JAM, et al. 1996;2(1):51-58. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Int J Artif Organs. LifeLine CardioVascular Unique axis of suspension results in leaflet movement responsive to physiological demands; Gentle, passive washing ensures complete washing of the pivot in both open and closed positions; Most patients cannot hear the sound of their valve after implantation; Low levels of hemolysis and thromboembolic events Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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%. You shall at all times use the Licensed Software in compliance with all applicable laws. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software. 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 Surg Forum. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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 . 1999; 22:754-763. U.S. Food & Drug Administration. MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Ln N Plymouth MN 55447-5439: Manufacturer Reason for Recall: Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. Certain complications may occur with heart valve procedures. 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. Potential Adverse Events: Certain complications may occur with heart valve procedures. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. . 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. 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. J Thorac Cardiovasc Surg. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. 2001;4(4):346-352. Products 25 November 2022 0 Comments. Accessed April 20, 2021. Heart Surgery Forum. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America. ) Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Open Pivot Aortic Valved Graft Ann Thorac Surg. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Five-year follow up of the ATS mechanical heart valve. Term, Termination, Modifications, and Support. Fifteen years single-center experience with the ATS bileaflet valve. 1996;10(8):660-665. 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. Technical Support. The valve itself was correctly labeled as Mitral. Active Remote Viewer as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a terrorist supporting country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Home 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. 1996;10(8):660-665. Products Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. 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.
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