Medtronic Open Pivot Heart Valve Instructions for Use. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. FDA Determined Cause 2: Labeling mix-ups . 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. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Products Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Open Pivot valves are remarkably quiet.7,10. Fifteen years of experience with ATS mechanical heart valve prostheses. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Medtronic Open Pivot Heart Valve Instructions for Use. 2004 Mar;13(2):231-238. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. Shiono M, Sezai Y, Sezai A, et al. November 1999;22(11):754-763. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Cardiovascular Active Remote Users. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. 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. 2006; 33: 154-159. Important Safety Information. U.S. Food & Drug Administration. 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. More than 140,000 valves have been implanted worldwide. Contraindications: None known . 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. ) Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 2000;69:507-512. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. Legal Compliance. With an updated browser, you will have a better Medtronic website experience. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. J Thorac Cardiovasc Surg. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Products Fifteen years single-center experience with the ATS bileaflet valve. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Healthcare Professionals To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories 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. Certain complications may occur with heart valve procedures. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Heart Valves Surgical Open Pivot valves are remarkably quiet.7,10. Washington D.C.: U.S. Food and Drug Administration; 2000. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Home Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Effects of magnetic fields used in MRI on 15 prosthetic heart valves. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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). Note: Manuals can be viewed using a current version of any major internet browser. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU FOR INTERCEPTION OR COMPROMISE OF ANY INFORMATION OR FOR ANY RECORD OR OTHER COMMUNICATION PROVIDED IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. 2003;75(2):444-452. 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. Emery RW, Van Nooten GJ, Tesar PJ. F 708.478.3519. Products Cardiovascular Update my browser now. Update my browser now. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Emery RW, Petersen RJ, Kersten TE, et al. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Important Labeling Information for United States. 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. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Heart Surg Forum. Heart Valves Surgical Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. 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. Sezai A, Shiono M, Orime Y, et al. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. LifeLine CardioVascular Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Cardiovascular 2003;75(2):444-452. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Limitations of Liability. The user name and password are personal to you and must not be shared with anyone else. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. March 2004;13(2):231-238. Disclaimer: This page may include information about products that may not be available in your region or country. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. data, and the Medtronic valves are no exception. New York: Springer Verlag; 1998:53-71. 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. Patients Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Eur J Cardio-thorac Surg. You shall at all times use the Licensed Software in compliance with all applicable laws. (4) Hassler M, et al. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Cardiovascular Emery RW, Petersen RJ, Kersten TE, et al. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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 For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. J Vasc Surg. Products If you continue, you may go to a site run by someone else. Indications, Safety, & Warnings. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Shiono M, Sezai Y, Sezai A, et al. Open Pivot Mechanical Heart Valves 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. Home The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Accessed April 20, 2021. Healthcare Professionals 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. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. Security/Privacy of Patient Data. 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. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. Note: Manuals can be viewed using a current version of any major internet browser. Note: Manuals can be viewed using a current version of any major internet browser. Email: Corporate.UDI@medtronic.com CLOSE . However, further studies are required to determine the effect of valve gradient on survival. Your Acknowledgements. 2009;18(4):445-452. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Fifteen years single-center experience with the ATS bileaflet valve. Home 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. The content may not be approved for use in your specific region or country. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Cardiovascular 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. 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. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Emery RW, Van Nooten GJ, Tesar PJ. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Valves and Annuloplasty Rings More. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. J Heart Valve Dis. Potential Adverse Events: Certain complications may occur with heart valve procedures. Advancing the Technology of Bileaflet Mechanical HeartValves. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 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. Heart Valves Surgical 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 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. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. 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. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Note: Manuals can be viewed using a current version of any major internet browser. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card All information that you provide in connection with such registration must be complete, accurate, and truthful. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Home Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. J Heart Valve Dis. The Suture Superstore that provides surgical disposables, sutures & more. Cell Mater. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. Int J Artif Organs. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 1996;10(8):660-665. Five-year follow up of the ATS mechanical heart valve. 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. Krian A. When im-planted in the aortic position there were only . Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Products Ann Thorac Cardiovasc Surg. Heart Valves Surgical Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Phone Numbers. . Permissions. This site is Exclusively Sponsored by BRACCO. Premarket Approval (PMA). Indications, Safety, and Warnings. Sezai A, Shiono M, Orime Y, et al. J Heart Valve Dis. 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 Open Pivot Aortic Valved Graft. In: Krian A, Matloff JM, Nicoloff DM, eds. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Premarket Approval (PMA). Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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). 2001;4(4):346-352. 1996;6: 273-79. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 1996;10(8):660-665. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. J Radiol 1986;67:661-666. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Van Nooten GJ, Caes F, Francois K, et al. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. New York: Springer Verlag; 1998:53-71. The reoperation rate was 1.2%. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) 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. 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 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. March 2004;13(2):231-238. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. In: Krian A, Matloff JM, Nicoloff DM, eds. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Heart Surgery Forum. 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). Your Personal Information. 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. This Agreement constitutes the entire agreement between Medtronic and you regarding your use of the Licensed Software and supersedes any prior and contemporaneous written or oral agreements or understandings related to the Licensed Software. 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. 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. With an updated browser, you will have a better Medtronic website experience. Healthcare Professionals The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Technical Support. Ann Thorac Cardiovasc Surg. Term, Termination, Modifications, and Support.
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