THE List - MRI Safety Home It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Update my browser now. Sezai A, Hata M, Niino T, et al. March 2004;13(2):231-238. 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. AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) Heart Surg Forum. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Phone Numbers. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Ann Thorac Surg. 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 You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Warnings/Precautions/Adverse Events A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. The Suture Superstore that provides surgical disposables, sutures & more. Home Session Key. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. November 1999;22(11):754-763. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Home The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. New York: Springer Verlag; 1998:53-71. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Long-term outcomes following Medtronic Open Pivot valved conduit Heart Valves Surgical You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. Products Premarket Approval (PMA). Emery RW, Petersen RJ, Kersten TE, et al. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Note: Manuals can be viewed using a current version of any major internet browser. Heart Valves Surgical Products Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Home On-X Aortic Heart Valve Hemodynamics - CryoLife, Inc. 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. 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. Products Open Pivot Mechanical Heart Valves. 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. 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. ) 2003;75(2):444-452. 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. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Heart Surg Forum. Healthcare Professionals Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Home 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. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. . It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Cardiovascular Update my browser now. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft AccessGUDID - DEVICE: Open Pivot (00643169078109) Fifteen years single-center experience with the ATS bileaflet valve. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Ann Thorac Surg. 1996;2(1):51-58. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. 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. Ann Thorac Surg. 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. 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. Note: Manuals can be viewed using a current version of any major internet browser. 2009;18(4):445-452. Eur J Cardiothorac Surg. 2001;4(4):346-352. 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. 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. Cell Mater. 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. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Premarket Approval (PMA). 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. With an updated browser, you will have a better Medtronic website experience. Open Pivot Aortic Valved Graft. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Term, Termination, Modifications, and Support. Eur J Cardio-thorac Surg. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. If you continue, you will leave this site and go to a site run by someone else. Medtronic Open Pivot | Manualzz With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Certain complications may occur with heart valve procedures. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Accelerated structural 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, or hyperparathyroidism). 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 agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Update my browser now. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Cardiovascular 1996; 2(1):51-58. Accelerated structural 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, or hyperparathyroidism). Int J Artif Organs. Emery RW, Krogh CC, Jones DJ, et al. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. 2006; 33: 154-159. Twenty-Year Single-Center Experience With the Medtronic Open Pivot Note: Manuals can be viewed using a current version of any major internet browser. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Safety Topic / Subject Article Text 179: . The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form.
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