At any time upon Medtronics request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. Products 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. P 844-SUTURES (788-8737) P 888.416.2409. Eur J Cardiothorac Surg. 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). This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Cardiovascular Fifteen years single-center experience with the ATS bileaflet valve. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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. The Suture Superstore that provides surgical disposables, sutures & more. All information that you provide in connection with such registration must be complete, accurate, and truthful. J Heart Valve Dis. Heart Valves Surgical Heart Surgery Forum. Fifteen years single-center experience with the ATS bileaflet valve. 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. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Technical Support. Accessed April 20, 2021. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. With an updated browser, you will have a better Medtronic website experience. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. 2001;4(4):346-352. 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. 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. On-X Life Technologies, Inc. P000037 S059: 03/24/2022: medtronic open pivot heart valve, medtronic open p. MEDTRONIC ATS MEDICAL, INC. P990046 S063: 03/11/2022: open pivot mechanical valve (ophv), open pivot aor. If you continue, you will leave this site and go to a site run by someone else. Healthcare Professionals 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. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Premarket Approval (PMA). Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Int J Artif Organs. 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. Ann Thorac Surg. F 708.478.3519. 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. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Email: Corporate.UDI@medtronic.com CLOSE . Aortic and Mitral Valve Replacement Safety Topic / Subject Article Text 179: . Certain complications may occur with heart valve procedures. Tex Heart Inst J. 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). Advancing the Technology of Bileaflet Mechanical HeartValves. Your Acknowledgements. 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. Premarket Approval (PMA). Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. 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. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Ann Thorac Cardiovasc Surg. 1996; 2(1):51-58. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Emery RW, Petersen RJ, Kersten TE, et al. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Heart Surg Forum. The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Medtronic Open Pivot Heart Valve Instructions for Use. Products You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Surface chemistry and surface roughness of clinical pyrocarbons. 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. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Int J Artif Organs. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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. 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. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Heart Valves and Annuloplasty Rings More. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. With an updated browser, you will have a better Medtronic website experience. 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. 2001;4(4):346-352. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. 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. 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 Advanced Discussion (show/hide) References 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. ) Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Note: Manuals can be viewed using a current version of any major internet browser. This device may be used to replace a previously implanted prosthetic heart valve or conduit. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Five-year follow up of the ATS mechanical heart valve. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. Important Safety Information. Products 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Update my browser now. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Open Pivot Mechanical Heart Valve. Adverse events can include: angina, cardiac dysrhythmias, death, endocarditis, heart failure, hemolytic anemia, infection other than endocarditis, myocardial infarction, root dilatation, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Treatments & Therapies Disclaimer: This page may include information about products that may not be available in your region or country. 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 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 September 1993;106(3):427-433. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Van Nooten GJ, Caes F, Francois K, et al. J Thorac Cardiovasc Surg. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While 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.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. Warnings/Precautions/Adverse Events Ann Thorac Surg. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Security/Privacy of Patient Data. 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. 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. ) Home Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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. Home Accessed April 20, 2021. This site is Exclusively Sponsored by BRACCO. Ann Thorac Surg. However, further studies are required to determine the effect of valve gradient on survival. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Home 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 1996;6: 273-79. 2003;75(2):444-452. 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. 1996;10(8):660-665. Potential Adverse Events: Certain complications may occur with heart valve procedures. Open Pivot valves are remarkably quiet.7,10. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Heart Valves Surgical 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. 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. Cardiovascular 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. U.S. Food & Drug Administration. 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. You shall at all times use the Licensed Software in compliance with all applicable laws. 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. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Indications, Safety, and Warnings. 1999; 22:754-763. March 2004;13(2):231-238. It is possible that some of the products on the other site are not approved in your country. Van Nooten GJ, Caes F, Francois K, et al. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. on x prosthetic heart valve ascending aortic proth. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 6-8 Outstanding Durability Emery RW, Petersen RJ, Kersten TE, et al. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. Int J Artif Organs. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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). Emery RW, Petersen RJ, Kersten TE, et al. 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Therapies & Procedures Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. 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. 2003;75(2):444-452. 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. 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 ]. 1996;2(1):51-58. Open Pivot Aortic Valved Graft. Surgical Heart Valve Repair and Replacement Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Important Labeling Information for United States. 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.
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