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LifeLine CardioVascular 1996;2(1):51-58. Technical Support. You just clicked a link to go to another website. This device may be used to replace a previously implanted prosthetic heart valve or conduit. J Radiol 1986;67:661-666. Emery RW, Petersen RJ, Kersten TE, et al. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. 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. Medtronic Open Pivot Aortic Valved Graft (AVG) for Aortic Valve and Ascending Aorta Replacement The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. For a Remote Viewer to view information displayed on a Programmer, the Remote Viewer needs to install or access the Bomgar Representative Console software (Licensed Software). Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Important Safety Information. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Heart Valves Surgical 2006; 33: 154-159. 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. 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. Home Healthcare Professionals The content may not be approved for use in your specific region or country. 2009;18(4):445-452. Cell Mater. Update my browser now. Products Shiono M, Sezai Y, Sezai A, et al. 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). 2001;4(4):346-352. 1996(10):660-665. 2001; 4(4):346-353. Note: Manuals can be viewed using a current version of any major internet browser. Clinical results of a large series of ATS valve implants. 2003;75(2):444-452. The reoperation rate was 1.2%. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Int J Artif Organs. 6-8 Outstanding Durability Healthcare Professionals With an updated browser, you will have a better Medtronic website experience. Heart Surgery Forum. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. U.S. Food & Drug Administration. With an updated browser, you will have a better Medtronic website experience. 1996;2(1):51-58. 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. LifeLine CardioVascular Note: Manuals can be viewed using a current version of any major internet browser. J Heart Valve Dis. Eur J Cardiothorac Surg. However, further studies are required to determine the effect of valve gradient on survival. Tex Heart Inst J. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 2010;139:1494-1500. Update my browser now. Sezai A, Hata M, Niino T, et al. Fifteen years of experience with ATS mechanical heart valve prostheses. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Even very old stainless steel valves are likewise considered of no danger in MRI. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 3: Conditional 5 More. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. Products Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 1996;10(8):660-665. 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 MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Warnings/Precautions/Adverse Events Home Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Open Pivot valves are remarkably quiet.7,10. In: Krian A, Matloff JM, Nicoloff DM, eds. Update my browser now. Shellock R & D Services, Inc. email: [email protected]. J Thorac Cardiovasc Surg. Note: Manuals can be viewed using a current version of any major internet browser. These improvements led to low thromboembolic rates of 1.25% per patient year and encouraged a reduction in anticoagulation treatment to an INR of 1.5 to 2.5 in isolated aortic valve replacement cases [ 179 ]. Open Pivot Aortic Valved Graft. Surface chemistry and surface roughness of clinical pyrocarbons. Krian A. More R and Haubold A. Int J Artif Organs. 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%. Open Pivot Mechanical Heart Valves. 1996; 2(1):51-58. Update my browser now. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. 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 HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Medtronic open pivot mechanical valves offer exceptional performance: The Open Pivot AP360 provides these additional features: The Open Pivot AP 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. Active Remote Users. All information that you provide in connection with such registration must be complete, accurate, and truthful. Products Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. 1996;6: 273-79. 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 perceval sutureless heart valve: CORCYM Canada Corp. P150011 S026: 11/21/2022: exoseal vascular closure device: Cordis US Corporation: P100013 S026: 10/28/2022: vibrant soundbridge system: Med-el Elektromedizinische Ger: P990052 S026: 10/11/2022: r3 delta ceramic acetabular system: Smith & Nephew, Inc. P150030 S026: 09/21/2022: relayplus . Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. Medtronic Open Pivot Heart Valve Instructions for Use. 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. Healthcare Professionals MRI Resources, For clinicians whose patients have a Medtronic system. Home Heart Valves Surgical You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Limitations of Liability. Emery RW, Van Nooten GJ, Tesar PJ. 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. Products Cardiovascular 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. Home Heart Valves Surgical 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. 2004 Mar;13(2):231-238. Emery RW, Van Nooten GJ, Tesar PJ. This site is Exclusively Sponsored by BRACCO. Products Five-year follow up of the ATS mechanical heart valve. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 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. Please review applicable product labeling for your country for indications and instructions prior to use. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. You just clicked a link to go to another website. J Heart Valve Dis. 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. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 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. Healthcare Professionals 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. Term, Termination, Modifications, and Support. 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. Disclaimer: This page may include information about products that may not be available in your region or country. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. J Heart Valve Dis. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Advancing the Technology of Bileaflet Mechanical HeartValves. Open Pivot Aortic Valved Graft Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Shiono M, Sezai Y, Sezai A, et al. J Heart Valve Dis. MEDTRONIC ATS MEDICAL . 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. 2,3 . Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. The user name and password are personal to you and must not be shared with anyone else. 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. Permissions. 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Click OK to confirm you are a Healthcare Professional. Fifteen years single-center experience with the ATS bileaflet valve. J Vasc Surg. Eur J Cardiothorac Surg. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Potential Adverse Events: Certain complications may occur with heart valve procedures. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. Adverse events can include: angina, cardiac dysrhythmias, death, endocarditis, heart failure, hemolytic anemia, infection other than endocarditis, myocardial infarction, root dilatation, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Technical Support. 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. Ann Thorac Surg. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Phone Numbers. 2000;69:507-512. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Contraindications: None known . Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. With an updated browser, you will have a better Medtronic website experience. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Emery RW, Petersen RJ, Kersten TE, et al. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Accessed April 20, 2021. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. J Heart Valve Dis. Eur J Cardiothorac Surg. LifeLine CardioVascular November 1999;22(11):754-763. More than 140,000 valves have been implanted worldwide. Accessed April 20, 2021. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Emery RW, Van Nooten GJ, Tesar PJ. 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. ) All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. November 1999;22(11):754-763. 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. Fifteen years single-center experience with the ATS bileaflet valve. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. 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 Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 1999; 22:754-763. 2003;75(2):444-452. data, and the Medtronic valves are no exception. 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. 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. 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. 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). Security/Privacy of Patient Data. Five-year follow up of the ATS mechanical heart valve. The Suture Superstore that provides surgical disposables, sutures & more. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for Aortic Valve and Ascending Aorta Replacement, 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. 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. Surgical Heart Valve Repair and Replacement 2000;69:507-512. 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. Krian A. 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.