This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. J Heart Valve Dis. Healthcare Professionals 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. In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. Open Pivot Mechanical Heart Valve - Medtronic J Heart Valve Dis. Heart Valves Surgical The valve itself was correctly labeled as Mitral. 2000;69:507-512. When im-planted in the aortic position there were only . 2009;18(4):445-452. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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 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. If you continue, you may go to a site run by someone else. Security/Privacy of Patient Data. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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. Open Pivot Mechanical Heart Valve. More R and Haubold A. 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. Int J Artif Organs. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 If you continue, you will leave this site and go to a site run by someone else. Fifteen years of experience with ATS mechanical heart valve prostheses. Five-year follow up of the ATS mechanical heart valve. By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User: ) Registration. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Open Pivot valves are remarkably quiet.7,10. 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. Note: Manuals can be viewed using a current version of any major internet browser. Clinical results of a large series of ATS valve implants. Phone Numbers. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. 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). Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. THE List - MRI Safety Home It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. MR safety: cardiac valves - Questions and Answers in MRI AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. March 2004;13(2):231-238. The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, ormalfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. 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. ) 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. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. Fifteen years single-center experience with the ATS bileaflet valve. It is possible that some of the products on the other site are not approved in your region or country. Emery RW, Petersen RJ, Kersten TE, et al. Update my browser now. 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. Indications, Safety, and Warnings - Medtronic The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Open Pivot Mechanical Heart Valves For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Premarket Approval (PMA). Cardiovascular Ann Thorac Surg. Fifteen years single-center experience with the ATS bileaflet valve. 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. 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. (4) Hassler M, et al. Eur J Cardiothorac Surg. 1996;2(1):51-58. November 1999;22(11):754-763. Washington D.C.: U.S. Food and Drug Administration; 2000. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 2000;69:507-512. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. 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%. New York: Springer Verlag; 1998:53-71. Five-year follow up of the ATS mechanical heart valve. MRI Resources | Medtronic Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com 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. Technical Support. 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. 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). Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Medtronic Open Pivot Aortic Valved Graft (AVG) 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. 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 ]. Email: Corporate.UDI@medtronic.com CLOSE . U.S. Food & Drug Administration. FDA Determined Cause 2: Labeling mix-ups . You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Therapies & Procedures Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. Heart Valves Surgical 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 Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Cardiovascular Important Safety Information. Emery RW, Van Nooten GJ, Tesar PJ. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision.
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