You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. The user name and password are personal to you and must not be shared with anyone else. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 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. 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). Indications, Safety, & Warnings. Home Clinical results of a large series of ATS valve implants. Ann Thorac Surg. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Home Certain complications may occur with heart valve procedures. Email: Corporate.UDI@medtronic.com CLOSE . September 1993;106(3):427-433. Heart Valves Surgical The initial United States experience with the ATS mechanical cardiac valve prosthesis. Technical Support. With an updated browser, you will have a better Medtronic website experience. Update my browser now. The valve itself was correctly labeled as Mitral. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. With an updated browser, you will have a better Medtronic website experience. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 2009;18(4):445-452. 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. ) Accessed April 20, 2021. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Heart Surg Forum. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Surface chemistry and surface roughness of clinical pyrocarbons. Your use of the other site is subject to the terms of use and privacy statement on that site. Click Continue to close this window and view the sites content. New York: Springer Verlag; 1998:53-71. You just clicked a link to go to another website. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. If not approved, please exit this site. When im-planted in the aortic position there were only . 2006; 33: 154-159. Logging of Session Activity. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve 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 Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. 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 Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Heart Valve Replacement - Surgical Five-year follow up of the ATS mechanical heart valve. Clinical results of a large series of ATS valve implants. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 2001; 4(4):346-353. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Washington D.C.: U.S. Food and Drug Administration; 2000. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 2,3 . 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can 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 . Open Pivot Aortic Valved Graft on x prosthetic heart valve ascending aortic proth. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. March 2004;13(2):231-238. 2003;75(2):444-452. FDA Determined Cause 2: Labeling mix-ups . Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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. Ann Thorac Surg. data, and the Medtronic valves are no exception. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Home Heart Valves Surgical In: Krian A, Matloff JM, Nicoloff DM, eds. 2001;4(4):346-352. Click OK to confirm you are a Healthcare Professional. Safety Topic / Subject Article Text 179: . Krian A. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Healthcare Professionals 1996;10(8):660-665. In: Krian A, Matloff JM, Nicoloff DM, eds. With an updated browser, you will have a better Medtronic website experience. Brand Name: Medtronic Open Pivot Version or Model: 569 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC 3F THERAPEUTICS, INC. Primary DI Number: 00763000318581 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527232 * Terms of Use With an updated browser, you will have a better Medtronic website experience. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Ann Thorac Cardiovasc Surg. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Important Labeling Information for United States. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. J Radiol 1986;67:661-666. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Active Remote Users. 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 ]. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Fifteen years single-center experience with the ATS bileaflet valve. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. Heart Valves Surgical Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 2000;69:507-512. Eur J Cardiothorac Surg. 2004 Mar;13(2):231-238. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Important Safety Information. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. MEDTRONIC ATS MEDICAL . March 2004;13(2):231-238. 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. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software. Potential Adverse Events: Certain complications may occur with heart valve procedures. Miscellaneous. 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. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement, Medtronic Open Pivot Aortic Valved Graft, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Single-plane orifice facilitates valve seating and implant regardless of suture technique. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Heart Valves Surgical P 844-SUTURES (788-8737) P 888.416.2409. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Healthcare Professionals 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. Potential Adverse Events: Certain complications may occur with heart valve procedures. 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. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Emery RW, Van Nooten GJ, Tesar PJ. 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. 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. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 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 and/or mitral heart valves. 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 intended for use secondary to a diseased, damaged, ormalfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. Please consult the approved indications for use. 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%. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 2003;75(2):444-452. Van Nooten GJ, Caes F, Francois K, et al. 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. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Technical Support. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. If you continue, you may go to a site run by someone else. Krian A. The Suture Superstore that provides surgical disposables, sutures & more. The Open Pivot AP360 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 the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Update my browser now. 2009;18(4):445-452. Cardiovascular Legal Compliance. 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. 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 patients who require replacement of their native or prosthetic aortic and/or mitral valves. Cardiovascular Warnings/Precautions/Adverse Events More R and Haubold A. 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Ann Thorac Surg. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Sezai A, Hata M, Niino T, et al. (4) Hassler M, et al. what happened in 1906 in europe 1996;10(8):660-665. 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. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. U.S. Food & Drug Administration. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG.