Important Safety Information. Van Nooten GJ, Caes F, Francois K, et al. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 2003;75(2):444-452. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Update my browser now. The Suture Superstore that provides surgical disposables, sutures & more. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Note: Manuals can be viewed using a current version of any major internet browser. Technical Support. 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. 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 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. Open Pivot Mechanical Heart Valves. Patients J Radiol 1986;67:661-666. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. J Thorac Cardiovasc Surg. 2006; 33: 154-159. March 1993;17(3):538-545. Heart Valves and Annuloplasty Rings More. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Van Nooten GJ, Caes F, Francois K, et al. 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. Premarket Approval (PMA). With an updated browser, you will have a better Medtronic website experience. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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). 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. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. 2009;18(4):445-452. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. If not approved, please exit this site. Heart Valves and Annuloplasty Rings More. Products Heart Valve Replacement - Surgical With an updated browser, you will have a better Medtronic website experience. 6-8 Outstanding Durability You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. By installing or using the Licensed Software to view the Programmer screen information, registering a username and password in connection with the Medtronic RemoteView feature, or clicking on any acceptance button in connection herewith, you, a Remote Viewer, agree to be bound by all of the terms and conditions set forth in these Terms of Use (this Agreement). J Heart Valve Dis. Potential Adverse Events: 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. Ann Thorac Cardiovasc Surg. , chronic renal failure, hyperparathyroidism). Premarket Approval (PMA). Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Accessed April 20, 2021. 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. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Technical Support. Int J Artif Organs. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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. In addition, upon Medtronics request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction. It is possible that some of the products on the other site are not approved in your region or country. Cardiovascular Update my browser now. 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 AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 2009;18(4):445-452. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Healthcare Professionals The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Emery RW, Petersen RJ, Kersten TE, et al. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. Shiono M, Sezai Y, Sezai A, et al. Indications, Safety, & Warnings. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. 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. ) A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Certain complications may occur with heart valve procedures. LifeLine CardioVascular Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. 3: Conditional 5 More. Healthcare Professionals Ann Thorac Surg. J Heart Valve Dis. Clinical results of a large series of ATS valve implants. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 2001;4(4):346-352. Home Click OK to confirm you are a Healthcare Professional. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 1996;2(1):51-58. Thus, a patient with any heart valve prosthesis listed in Table 1 undergoing an MRI procedure using an MR system operating at 1.5 T or less would not be at risk with regard to movement or dislodgement of the implant. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, 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. Eur J Cardiothorac Surg. J Thorac Cardiovasc Surg. Ann Thorac Surg. J Heart Valve Dis. Please consult the approved indications for use. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. 25 November 2022 0 Comments. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. The user name and password are personal to you and must not be shared with anyone else. MeSH terms Adolescent Adult Aged Aorta / surgery* 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 ]. Eur J Cardiothorac Surg. The content may not be approved for use in your specific region or country. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Session Key. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Ln N Plymouth MN 55447-5439: Manufacturer Reason for Recall: Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. . Update my browser now. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 1996;2(1):51-58. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 LifeLine CardioVascular You just clicked a link to go to another website. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Miscellaneous. Indications, Safety, & Warnings. Home Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. With an updated browser, you will have a better Medtronic website experience. 2000;69:507-512. November 1999;22(11):754-763. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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. Home Except as expressly provided herein, no person or entity other than Medtronic and you, including without limitation any patient, is or shall be a third party beneficiary of this Agreement or otherwise entitled to bring any action to enforce any provision of this Agreement against Medtronic or you. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Update my browser now. F 708.478.3519. Tex Heart Inst J. Cardiovascular A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Your use of the other site is subject to the terms of use and privacy statement on that site. March 2004;13(2):231-238. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Update my browser now. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. P 844-SUTURES (788-8737) P 888.416.2409. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Heart Valves Surgical To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. With an updated browser, you will have a better Medtronic website experience. Home 2000;69:507-512. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Accessed April 20, 2021. 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. ) Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 1996;10(8):660-665. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Ann Thorac Surg. Proven Graft Material U.S. Food & Drug Administration. 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. Contraindications: None known . 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. 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. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Ann Thorac Cardiovasc Surg. 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.
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