For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. FDA Determined Cause 2: Labeling mix-ups . 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 Contraindications: None known . Open Pivot Mechanical Heart Valve - Medtronic Emery RW, Petersen RJ, Kersten TE, 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, 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. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 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. ) Premarket Approval (PMA). Ats Medical Heart Valve Mri Safety | Day of Difference Advancing the Technology of Bileaflet Mechanical HeartValves. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Sezai A, Hata M, Niino T, et al. Products Heart Valve Design & Features - CryoLife, Inc. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. November 1999;22(11):754-763. Krian A. Safety Topic / Subject Article Text 179: . 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. J Heart Valve Dis. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Heart Valves Surgical Ann Thorac Surg. Your Acknowledgements. 6-8 Outstanding Durability The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 1996(10):660-665. 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 Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Home 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. Technical Support. Update my browser now. However, further studies are required to determine the effect of valve gradient on survival. Early results. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. In the event that any provision of this Agreement violates any applicable statute, ordinance, or rule of law, such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement. Accessed April 20, 2021. 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. Healthcare Professionals MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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. Certain complications may occur with heart valve procedures. 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. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. Emery RW, Van Nooten GJ, Tesar PJ. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. MRI Resources, For clinicians whose patients have a Medtronic system. 25 November 2022 0 Comments. . 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. In: Krian A, Matloff JM, Nicoloff DM, eds. 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. Healthcare Professionals Open Pivot Mechanical Heart Valves Premarket Approval (PMA). Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. A recent publication from a single center in Belgium followed all patients with an Open Pivot valve im-planted over a 20 year period.81 In total, 1520 Open Pivot valves were implanted in 1382 consecutive patients with a 99% rate of follow-up. The reoperation rate was 1.2%. J Radiol 1986;67:661-666. Fifteen years of experience with ATS mechanical heart valve prostheses. Your use of the other site is subject to the terms of use and privacy statement on that site. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. NayaMed International Srl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Srl. 3: . Shiono M, Sezai Y, Sezai A, et al. Session Key. Your Personal Information. 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.
Borderline Personality Disorder Eye Contact,
Who Killed The Lobbyist In Bones,
Kia Vaughn And Gary Ervin Wedding,
Arocep Ultra Bleach Safety Data Sheet,
Articles M
