1996(10):660-665. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. J Heart Valve Dis. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. Eur J Cardiothorac Surg. Eur J Cardiothorac Surg. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. J Heart Valve Dis. Home Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Home You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Session Key. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Click Continue to close this window and view the sites content. Miscellaneous. U.S. Food & Drug Administration. 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 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. 2001; 4(4):346-353. 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. LifeLine CardioVascular Int J Artif Organs. 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. 1996;10(8):660-665. The valve itself was correctly labeled as Mitral. Heart Surg Forum. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Term, Termination, Modifications, and Support. Washington D.C.: U.S. Food and Drug Administration; 2000. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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. on x prosthetic heart valve ascending aortic proth. 2001;4(4):346-352. MRI Resources, For clinicians whose patients have a Medtronic system. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. 3: . The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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: Krian A, Matloff JM, Nicoloff DM, eds. Treatments & Therapies CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Your Personal Information. Technical Support. Five-year follow up of the ATS mechanical heart valve. You shall at all times use the Licensed Software in compliance with all applicable laws. F 708.478.3519. Early results. Medtronic Open Pivot Heart Valve Instructions for Use. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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). Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Fifteen years single-center experience with the ATS bileaflet valve. 2009;18(4):445-452. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Products For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. November 1999;22(11):754-763. 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. ) Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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. 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. Indications, Safety, & Warnings. All information that you provide in connection with such registration must be complete, accurate, and truthful. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Tex Heart Inst J. Open Pivot Mechanical Heart Valve. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com This site is Exclusively Sponsored by BRACCO. 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 Accessed April 20, 2021. J Heart Valve Dis. 2003;75(2):444-452. The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. U.S. Food & Drug Administration. Healthcare Professionals 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. , chronic renal failure, hyperparathyroidism). Premarket Approval (PMA). A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. With an updated browser, you will have a better Medtronic website experience. Premarket Approval (PMA). Ann Thorac Surg. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Aortic and Mitral Valve Replacement AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. 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. Van Nooten GJ, Caes F, Francois K, et al. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. 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. Note: Manuals can be viewed using a current version of any major internet browser. Advancing the Technology of Bileaflet Mechanical HeartValves. 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. 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. Update my browser now. Shiono M, Sezai Y, Sezai A, et al. It is possible that some of the products on the other site are not approved in your country. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. 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. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Heart Valves Surgical Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Open Pivot Mechanical Heart Valves. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Update my browser now. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 2003;75(2):444-452. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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. Accessed April 20, 2021. Emery RW, Petersen RJ, Kersten TE, et al. Availability. Potential Adverse Events: Certain complications may occur with heart valve procedures. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 2006; 33: 154-159. 3: Conditional 5 More. J Thorac Cardiovasc Surg. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. 2009;18(4):445-452. The Suture Superstore that provides surgical disposables, sutures & more. 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. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Clinical results of a large series of ATS valve implants. Healthcare Professionals It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. 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. Open Pivot Mechanical Heart Valves. Update my browser now. The Medtronic Open Pivot AP360, AP, and Standard valves provide exceptional implantability, performance, and durability.1-3, Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. 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. With an updated browser, you will have a better Medtronic website experience. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. 1999; 22:754-763. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. J Heart Valve Dis. Note: Manuals can be viewed using a current version of any major internet browser. Heart Valves Surgical Cardiovascular With an updated browser, you will have a better Medtronic website experience. 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. 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. Fifteen years of experience with ATS mechanical heart valve prostheses. The parties hereby expressly waive any right to a trial by jury or class treatment of any claim, demand, action, or cause of action arising out of or relating to the Licensed Software or this Agreement. 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. With an updated browser, you will have a better Medtronic website experience. 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. ) Ann Thorac Cardiovasc Surg. 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. Heart Surgery Forum. 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. 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). MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User: ) Registration. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Shiono M, Sezai Y, Sezai A, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Ann Thorac Surg. With an updated browser, you will have a better Medtronic website experience. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Products 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. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a terrorist supporting country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties. If you continue, you may go to a site run by someone else. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. March 1993;17(3):538-545. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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. Heart Surg Forum. . 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. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Krian A. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Home 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.
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