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. 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. Update my browser now. MEDTRONIC ATS MEDICAL, INC. P990046 S065: 10/21/2022: open pivot heart valve, open pivot aortic valved g. MEDTRONIC ATS MEDICAL, INC. P990046 S064: 03/10/2022: 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. 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. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 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). Home Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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 Surg. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Int J Artif Organs. Healthcare Professionals Home Contraindications: None known . 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. 2003;75(2):444-452. Open Pivot Mechanical Heart Valve. Technical Support. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. March 2004;13(2):231-238. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Sezai A, Shiono M, Orime Y, et al. 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. Advancing the Technology of Bileaflet Mechanical HeartValves. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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 Fifteen years single-center experience with the ATS bileaflet valve. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Sezai A, Hata M, Niino T, et al. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. 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. Healthcare Professionals Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Emery RW, Van Nooten GJ, Tesar PJ. Emery RW, Petersen RJ, Kersten TE, et al. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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. Heart Valve Replacement - Surgical Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Ann Thorac Surg. 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 Eur J Cardiothorac Surg. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. Eur J Cardio-thorac Surg. Update my browser now. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Click OK to confirm you are a Healthcare Professional. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Note: Manuals can be viewed using a current version of any major internet browser. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Note: Manuals can be viewed using a current version of any major internet browser. J Thorac Cardiovasc Surg. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Medtronic Open Pivot Heart Valve Instructions for Use. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Shiono M, Sezai Y, Sezai A, et al. When im-planted in the aortic position there were only . Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Certain complications may occur with heart valve procedures. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. 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. 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. Emery RW, Petersen RJ, Kersten TE, et al. With an updated browser, you will have a better Medtronic website experience. 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). Sezai A, Shiono M, Orime Y, et al. 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. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. Home Emery RW, Van Nooten GJ, Tesar PJ. Int J Artif Organs. Heart Surgery Forum. Update my browser now. Potential Adverse Events: Certain complications may occur with heart valve procedures. In: Krian A, Matloff JM, Nicoloff DM, eds. F 708.478.3519. Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Clinical results of a large series of ATS valve implants. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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). J Heart Valve Dis. Int J Artif Organs. 2009;18(4):445-452. Ann Thorac Surg. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Update my browser now. 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. Home Heart Surg Forum. 2001;4(4):346-352. Update my browser now. 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. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. Heart Valves and Annuloplasty Rings More. 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. With an updated browser, you will have a better Medtronic website experience. Miscellaneous. Healthcare Professionals Surgical Heart Valve Repair and Replacement Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Cardiovascular 1996;2(1):51-58. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. Potential Adverse Events: Certain complications may occur with heart valve procedures. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS 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. Single-plane orifice facilitates valve seating and implant regardless of suture technique. However, further studies are required to determine the effect of valve gradient on survival. 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. Technical Support. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Medtronic Open Pivot Heart Valve Instructions for Use. Ann Thorac Surg. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 6-8 Outstanding Durability

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