A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. 1996;2(1):51-58. Please review applicable product labeling for your country for indications and instructions prior to use. Contraindications: None known . Heart Surg Forum. Cardiovascular Heart Valves and Annuloplasty Rings More. 2,9,10 Your use of the other site is subject to the terms of use and privacy statement on that site. Open Pivot Mechanical Heart Valves. 1996;6: 273-79. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. 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. 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. All information that you provide in connection with such registration must be complete, accurate, and truthful. 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. 2009;18(4):445-452. 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. March 2004;13(2):231-238. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Ann Thorac Surg. Availability. Clinical results of a large series of ATS valve implants. Van Nooten GJ, Caes F, Francois K, et al. 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. Tex Heart Inst J. New York: Springer Verlag; 1998:53-71. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 2009;18(4):445-452. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Medtronic may modify, disable, or terminate your use or Medtronics support of the Licensed Software at any time, including by providing notices on a Medtronic website. LifeLine CardioVascular Effects of magnetic fields used in MRI on 15 prosthetic heart valves. Shiono M, Sezai Y, Sezai A, et al. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, infection other than endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 2004 Mar;13(2):231-238. Sezai A, Shiono M, Orime Y, et al. 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. Int J Artif Organs. Adverse events can include: angina, cardiac dysrhythmias, death, endocarditis, heart failure, hemolytic anemia, infection other than endocarditis, myocardial infarction, root dilatation, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. J Heart Valve Dis. With an updated browser, you will have a better Medtronic website experience. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Premarket Approval (PMA). It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 2001;4(4):346-352. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. Note: Manuals can be viewed using a current version of any major internet browser. U.S. Food & Drug Administration. 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. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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. Permissions. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Home Healthcare Professionals Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 1996;2(1):51-58. Update my browser now. 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. 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. ) 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. Phone Numbers. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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. Please consult the approved indications for use. MEDTRONIC ATS MEDICAL . Home 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. ) Accessed April 20, 2021. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. With an updated browser, you will have a better Medtronic website experience. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 to 26 mm for aortic valve replacement, Intra-annular valve with generous, compliant cuff for exceptional implantability, Medtronic Open Pivot Sizer Kit includes AP Series and Standard heart valve sizers, a bendable holder handle, and a sterilization tray, Mitral Hex End Rotators and Holder provide additional length and flexibility when needed for rotation of mitral valves. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. You just clicked a link to go to another website. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Heart Valves Surgical Shiono M, Sezai Y, Sezai A, et al. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Home Proven Graft Material 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 Ann Thorac Surg. 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. Important Labeling Information for United States. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Cardiovascular Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Home 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. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.
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