MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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. 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Products Note: Manuals can be viewed using a current version of any major internet browser. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While 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.7,8. Phone Numbers. Potential Adverse Events: 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. FDA Determined Cause 2: Labeling mix-ups . Shiono M, Sezai Y, Sezai A, et al. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Premarket Approval (PMA). 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. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Heart Valve Replacement - Surgical Ann Thorac Cardiovasc Surg. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 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. Sezai A, Hata M, Niino T, et al. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. The adverse events potentially associated with the use of prosthetic aortic heart 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. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. March 2004;13(2):231-238. 2001;4(4):346-352. 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. Proven Graft Material on x prosthetic heart valve ascending aortic proth. 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. 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. Krian A. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. 1996;10(8):660-665. 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. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Accessed April 20, 2021. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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. Treatments & Therapies In: Krian A, Matloff JM, Nicoloff DM, eds. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Advancing the Technology of Bileaflet Mechanical HeartValves. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 2000;69:507-512. 2001;4(4):346-352. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. 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. The valve itself was correctly labeled as Mitral. Even very old stainless steel valves are likewise considered of no danger in MRI. Van Nooten GJ, Caes F, Francois K, et al. Patients Sezai A, Shiono M, Orime Y, et al. 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 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 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. 2003;75(2):444-452. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Advanced Discussion (show/hide) References LifeLine CardioVascular 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. Premarket Approval (PMA). These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. You just clicked a link to go to another website. J Heart Valve Dis. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Healthcare Professionals The initial United States experience with the ATS mechanical cardiac valve prosthesis. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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 Healthcare Professionals Your use of the other site is subject to the terms of use and privacy statement on that site. Ann Thorac Cardiovasc Surg. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Eur J Cardiothorac Surg. Note: Manuals can be viewed using a current version of any major internet browser. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Ann Thorac Cardiovasc Surg. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Ann Thorac Surg. Van Nooten GJ, Caes F, Francois K, et al. 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. It is possible that some of the products on the other site are not approved in your region or country. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Session Key. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. 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. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Ann Thorac Surg. 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. 2000;69:507-512. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. 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. 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 Note: Manuals can be viewed using a current version of any major internet browser. If you continue, you may go to a site run by someone else. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Heart Valves Surgical March 2004;13(2):231-238. Accessed April 20, 2021. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America. ) 2009;18(4):445-452. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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