These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Security/Privacy of Patient Data. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: J Vasc Surg. 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. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. March 1993;17(3):538-545. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. MRI Resources, For clinicians whose patients have a Medtronic system. 1996;10(8):660-665. Update my browser now. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. New York: Springer Verlag; 1998:53-71. 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. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. The initial United States experience with the ATS mechanical cardiac valve prosthesis. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 6-8 Outstanding Durability Treatments & Therapies Healthcare Professionals 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Clinical results of a large series of ATS valve implants. Emery RW, Petersen RJ, Kersten TE, et al. Open Pivot Aortic Valved Graft. This Agreement shall be governed by and interpreted, construed, and enforced in accordance with the laws of the State of Minnesota (exclusive of the choice of law rules thereof). You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. 2000;69:507-512. 1996;10(8):660-665. Contraindications: None known . Home Shiono M, Sezai Y, Sezai A, et al. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Medtronic Open Pivot Heart Valve Instructions for Use. 1996; 2(1):51-58. J Heart Valve Dis. The content may not be approved for use in your specific region or country. Technical Support. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Sezai A, Shiono M, Orime Y, et al. Ann Thorac Surg. Note: Manuals can be viewed using a current version of any major internet browser. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. September 1993;106(3):427-433. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Int J Artif Organs. 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. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Ann Thorac Surg. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. It is possible that some of the products on the other site are not approved in your country. 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. 2010;139:1494-1500. With an updated browser, you will have a better Medtronic website experience. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. . 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 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 Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Heart Valves Surgical Five-year follow up of the ATS mechanical heart valve. Accessed April 20, 2021. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Emery RW, Petersen RJ, Kersten TE, et al. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Technical Support. Home Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card 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. If you continue, you may go to a site run by someone else. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU FOR INTERCEPTION OR COMPROMISE OF ANY INFORMATION OR FOR ANY RECORD OR OTHER COMMUNICATION PROVIDED IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE. Emery RW, Petersen RJ, Kersten TE, et al. Products 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. Aortic and Mitral Valve Replacement 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. Medtronic Open Pivot Heart Valves Product Specifications medtronic open pivot Standard Heart valve Aortic Standard Tissue Annulus Orifice Inner Geometric Valve Size Model Diameter (B) Diameter (A) Orifice Area (mm) Number (mm) (mm) (cm2) 19 500FA19 19.5 14.8 1.55 21 500FA21 21.5 16.8 2.02 23 500FA23 23.5 18.8 2.56 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. 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. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Krian A. Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. Products Update my browser now. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. With regard to any purported agreement or terms of use between you and Bomgar Corporation in connection with the Licensed Software (Bomgar EULA): (a) any Bomgar EULA shall be solely between you and Bomgar Corporation; (b) Medtronic shall not be a party to any Bomgar EULA; (c) any Bomgar EULA shall not necessarily reflect the contents of any agreement between Bomgar Corporation and Medtronic; (d) any Bomgar EULA shall not modify or take precedence over this Agreement; and (e) nothing in this Agreement shall be construed to suggest the enforceability or unenforceability of any Bomgar EULA. With an updated browser, you will have a better Medtronic website experience. Open Pivot Mechanical Heart Valves. Clinical results of a large series of ATS valve implants. J Heart Valve Dis. 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. Indications, Safety, and Warnings. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. LifeLine CardioVascular 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). 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.
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