Clinical results of a large series of ATS valve implants. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. New York: Springer Verlag; 1998:53-71. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Open Pivot Mechanical Heart Valves. The valve itself was correctly labeled as Mitral. Open Pivot valves are remarkably quiet.7,10. This device may be used to replace a previously implanted prosthetic heart valve or conduit. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Accessed April 20, 2021. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. 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. 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. Disclaimer: This page may include information about products that may not be available in your region or country. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Legal Compliance. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. Miscellaneous. Atriasept Closure DeviceCardia, Inc.Eagan, MN, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., Lake Forrest, CA, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., www.navigatecsi.com, Atrix-C Cervical Allograft Interbody SpacerXtant Medical, www.xtantmedical.com, Atrostim Phrenic Nerve StimulatorASTROTECH OYTampere, Finland, ATS 3f Enable Aortic BioprosthesisModel 6000ATS Medical, Inc.Lake Forest, CA, ATS Medical Open PivotAortic Valved GraftModel # XX denotes size502AGxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAortic, Model 501DA18Advanced Performance (AP)pyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 AorticModel # XX denotes size505DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 MitralModel # XX denotes size505DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP AorticModel # XX denotes size501DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP MitralModel # XX denotes size501DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex AorticModel # XX denotes size503DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex MitralModel # XX denotes size503DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveMitral, Model 500DM29Standard Valvepyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard AorticModel # XX denotes size500FAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard MitralModel # XX denotes size500DMxxATS MedicalMinneapolis, M, ATTRACTOR Screw17-4 SSPorex Surgical, Newnan, GA, Attune Flexible Annuloplasty RingSt. 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 Therapies & Procedures Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Note: Manuals can be viewed using a current version of any major internet browser. 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. Update my browser now. More R and Haubold A. 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. (4) Hassler M, et al. 1996;2(1):51-58. If you continue, you will leave this site and go to a site run by someone else. data, and the Medtronic valves are no exception. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Emery RW, Van Nooten GJ, Tesar PJ. It is possible that some of the products on the other site are not approved in your country. Shiono M, Sezai Y, Sezai A, et al. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Emery RW, Krogh CC, Jones DJ, et al. Products Indications, Safety, & Warnings. Sezai A, Hata M, Niino T, et al. 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. J Heart Valve Dis. on x prosthetic heart valve ascending aortic proth. Eur J Cardiothorac Surg. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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. With an updated browser, you will have a better Medtronic website experience. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Five-year follow up of the ATS mechanical heart valve. 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. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . 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. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Heart Valves Surgical J Thorac Cardiovasc Surg. 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 larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Open Pivot Mechanical Heart Valve. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. With an updated browser, you will have a better Medtronic website experience. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Update my browser now. Medtronic Open Pivot Mechanical Valves Offer Exceptional Performance Remarkable Thromboresistance Continuous passive washing provides for gentle treatment of blood cells and low levels Excellent Hemodynamics In-vivo studies demonstrates improved hemodynamic performance following device implant. J Heart Valve Dis. Ann Thorac Surg. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Premarket Approval (PMA). 2003;75(2):444-452. Update my browser now. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card 1996;10(8):660-665. LifeLine CardioVascular 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. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. 2009;18(4):445-452. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. The reoperation rate was 1.2%. In: Krian A, Matloff JM, Nicoloff DM, eds. J Radiol 1986;67:661-666. Click Continue to close this window and view the sites content. Ann Thorac Surg. Heart Surg Forum. 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%. Indications, Safety, & Warnings. Important Safety Information. Mitral bi-leaflet mechanical heart valve prosthesis An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. 1996; 2(1):51-58. Central/Eastern Europe, Middle East & Africa, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement, Supra-annular compact cuff configuration for excellent suturability and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic and mitral 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. Session Key. With an updated browser, you will have a better Medtronic website experience. Ann Thorac Cardiovasc 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. 2009;18(4):445-452. Products The initial United States experience with the ATS mechanical cardiac valve prosthesis. You just clicked a link to go to another website. 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. Van Nooten GJ, Caes F, Francois K, et al. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Healthcare Professionals 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. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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: 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). 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. Int J Artif Organs. Cardiovascular September 1993;106(3):427-433. 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. Home Eur J Cardiothorac Surg. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Update my browser now. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. Krian A. Note: Manuals can be viewed using a current version of any major internet browser. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 1.5, 3: Healthcare Professionals ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. 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. 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. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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 U.S. Food & Drug Administration. Update my browser now. November 1999;22(11):754-763. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Sezai A, Shiono M, Orime Y, et al. J Heart Valve Dis. 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. Ann Thorac Cardiovasc Surg. Heart Valves Surgical 2006; 33: 154-159. The content may not be approved for use in your specific region or country. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 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. U.S. Food & Drug Administration. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. . You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. 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. ) 1996(10):660-665. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Emery RW, Petersen RJ, Kersten TE, et al. J Heart Valve Dis. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Logging of Session Activity. 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. If not approved, please exit this site. . 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. Medtronic Open Pivot Heart Valve Instructions for Use. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Patients CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Surface chemistry and surface roughness of clinical pyrocarbons. Your Personal Information. 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Cardiovascular 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. Accessed April 20, 2021. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Home Home 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. Potential Adverse Events: Certain complications may occur with heart valve procedures. Phone Numbers. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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.