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). 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%. Ann Thorac Surg. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Ann Thorac Surg. 1996(10):660-665. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. The valve itself was correctly labeled as Mitral. This site is Exclusively Sponsored by BRACCO. Ann Thorac Cardiovasc Surg. Premarket Approval (PMA). 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. 3: . Home Medtronic Open Pivot Heart Valve Instructions for Use. Indications, Safety, and Warnings - Open Pivot Mechanical Heart Valves AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. 1996;2(1):51-58. Int J Artif Organs. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. 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. Van Nooten GJ, Caes F, Francois K, et al. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Note: Manuals can be viewed using a current version of any major internet browser. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. AccessGUDID - DEVICE: Open Pivot (00643169078109) Update my browser now. Prosthetic heart valves: Evaluation of magnetic field interactions Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Int J Artif Organs. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) With an updated browser, you will have a better Medtronic website experience. Low target-INR anticoagulation is safe in selected aortic valve patients with the Medtronic Open Pivot mechanical prosthesis: Long-term results of a propensity-matched comparison with standard. Medtronic, Inc. (Medtronic) offers RemoteView, which permits a user (Programmer User) of the Medtronic CareLink 2090 Programmer (Programmer) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (Remote Viewer), including remote health care professionals or Medtronic representatives. Emery RW, Petersen RJ, Kersten TE, et al. Email: Corporate.UDI@medtronic.com CLOSE . Heart Valve Design & Features - CryoLife, Inc. Medtronic, Inc. ("Medtronic") offers RemoteView, which permits a user ("Programmer User") of the Medtronic CareLink2090 Programmer ("Programmer") to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world ("Remote Viewer"), including remote health care U.S. Food & Drug Administration. Indications, Safety, and Warnings. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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 . 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. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Heart Valves - Surgical | Medtronic Update my browser now. 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. 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. Emery RW, Van Nooten GJ, Tesar PJ. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. Accessed April 20, 2021. 2,9,10 Home 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 J Heart Valve Dis. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. 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. ) 2003;75(2):444-452. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. You just clicked a link to go to another website. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 2006; 33: 154-159. Int J Artif Organs. MEDTRONIC ATS MEDICAL . THE List - MRI Safety 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. March 1993;17(3):538-545. MeSH terms Adolescent Adult Aged Aorta / surgery* FDA Determined Cause 2: Labeling mix-ups . Open Pivot Mechanical Heart Valves. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Healthcare Professionals 2001; 4(4):346-353. Eur J Radiol 1992;2:555-558. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. 1996;10(8):660-665. Heart Valves Surgical 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 2004 Mar;13(2):231-238. Healthcare Professionals Products Update my browser now. Potential Adverse Events: Certain complications may occur with heart valve procedures. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 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. Cardiovascular The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. LifeLine CardioVascular
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