1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. 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. Products Please review applicable product labeling for your country for indications and instructions prior to use. 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. 1999; 22:754-763. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Open Pivot Mechanical Heart Valves - Surgical Heart Valves | Medtronic 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 1996;2(1):51-58. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. This Agreement shall be governed by and interpreted, construed, and enforced in accordance with the laws of the State of Minnesota (exclusive of the choice of law rules thereof). ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Your Personal Information. Eur J Cardiothorac Surg. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Atriasept Closure DeviceCardia, Inc.Eagan, MN, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., Lake Forrest, CA, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., www.navigatecsi.com, Atrix-C Cervical Allograft Interbody SpacerXtant Medical, www.xtantmedical.com, Atrostim Phrenic Nerve StimulatorASTROTECH OYTampere, Finland, ATS 3f Enable Aortic BioprosthesisModel 6000ATS Medical, Inc.Lake Forest, CA, ATS Medical Open PivotAortic Valved GraftModel # XX denotes size502AGxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAortic, Model 501DA18Advanced Performance (AP)pyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 AorticModel # XX denotes size505DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 MitralModel # XX denotes size505DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP AorticModel # XX denotes size501DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP MitralModel # XX denotes size501DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex AorticModel # XX denotes size503DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex MitralModel # XX denotes size503DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveMitral, Model 500DM29Standard Valvepyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard AorticModel # XX denotes size500FAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard MitralModel # XX denotes size500DMxxATS MedicalMinneapolis, M, ATTRACTOR Screw17-4 SSPorex Surgical, Newnan, GA, Attune Flexible Annuloplasty RingSt. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Emery RW, Van Nooten GJ, Tesar PJ. 2001; 4(4):346-353. Home Emery RW, Petersen RJ, Kersten TE, et al. 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. ) Five-year follow up of the ATS mechanical heart valve. In: Krian A, Matloff JM, Nicoloff DM, eds. 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. It is possible that some of the products on the other site are not approved in your country. Products In: Krian A, Matloff JM, Nicoloff DM, eds. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Update my browser now. THE List - MRI Safety Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Surgical Heart Valve Repair and Replacement You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Heart Valves Surgical You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Sezai A, Hata M, Niino T, et al. Potential Adverse Events: Certain complications may occur with heart valve procedures. J Heart Valve Dis. MR safety: cardiac valves - Questions and Answers in MRI Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Technical Support. Premarket Approval (PMA). Medtronic Open Pivot | Manualzz 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. Open Pivot Mechanical Heart Valves. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Open Pivot Aortic Valved Graft. Open Pivot Mechanical Heart Valves. Products Permissions. 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. J Thorac Cardiovasc Surg. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Reporting Issues and Feedback. . Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Healthcare Professionals In: Krian A, Matloff JM, Nicoloff DM, eds. Heart Valve Design & Features - CryoLife, Inc. November 1999;22(11):754-763. You just clicked a link to go to another website. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Ann Thorac Surg. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 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). LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Mechanical Heart Valves, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Phone Numbers. Fifteen years single-center experience with the ATS bileaflet valve. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Single-plane orifice facilitates valve seating and implant regardless of suture technique. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Open Pivot Mechanical Heart Valves - Surgical Heart Valves - Medtronic 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. Medtronic, Inc. (Medtronic) offers RemoteView, which permits a user (Programmer User) of the Medtronic CareLink 2090 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 professionals or Medtronic representatives. 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. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 1996;2(1):51-58. 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. Premarket Approval (PMA) - Food and Drug Administration Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Even very old stainless steel valves are likewise considered of no danger in MRI. 2,3 . on x prosthetic heart valve ascending aortic proth. 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 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. ) Update my browser now. Patients Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M 2004 Mar;13(2):231-238. Healthcare Professionals More R and Haubold A. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 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. ) Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) 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. Healthcare Professionals Premarket Approval (PMA). Advanced Discussion (show/hide) References 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. data, and the Medtronic valves are no exception. Potential Adverse Events: Certain complications may occur with heart valve procedures. 6-8 Outstanding Durability LifeLine CardioVascular You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Update my browser now. Healthcare Professionals For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. 505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm Heart Valves Surgical Legal Compliance. Your Acknowledgements. 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. Heart Valves - Surgical | Medtronic Home In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Home Indications, Safety, and Warnings - Open Pivot Aortic - Medtronic 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. 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. Indications, Safety, and Warnings. Shiono M, Sezai Y, Sezai A, et al. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Open Pivot valves are remarkably quiet.7,10. Accessed April 20, 2021. Prosthetic heart valves: Evaluation of magnetic field interactions 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. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. With an updated browser, you will have a better Medtronic website experience. Surface chemistry and surface roughness of clinical pyrocarbons. Ann Thorac Surg. Ann Thorac Surg. Open Pivot Aortic Valved Graft - Surgical Heart Valves | Medtronic 2001;4(4):346-352. 2000;69:507-512. 2003;75(2):444-452. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 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. , chronic renal failure, hyperparathyroidism). Please consult the approved indications for use. 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. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. 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. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Krian A. Object Info: - MRI Safety March 2004;13(2):231-238. However, further studies are required to determine the effect of valve gradient on survival. F 708.478.3519. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. MEDTRONIC 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. 2006; 33: 154-159. 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). 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. 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. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 1996; 2(1):51-58. J Heart Valve Dis. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic Products 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 . No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. Indications, Safety, and Warnings - Open Pivot Mechanical Heart Valves Active Remote Users. Open Pivot Aortic Valved Graft 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. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. 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. Update my browser now. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU OR YOUR ASSOCIATED HOSPITAL, CLINIC, OR PRACTICE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE, SESSIONS KEYS, OR THESE TERMS OF USE (WHETHER IN WARRANTY, CONTRACT, TORT, OR OTHERWISE, INCLUDING NEGLIGENCE, AND EVEN IF MEDTRONIC HAS BEEN ADVISED OF THE POSSIBILITY THEREOF), INCLUDING WITHOUT LIMITATION MEDICAL EXPENSES, LOSS OF REVENUE OR PROFITS, OR DAMAGES RESULTING FROM LOSS, MISAPPROPRIATION, OR UNAUTHORIZED OR MALICIOUS ACCESS TO OR MODIFICATION OF DEVICE DATA, OR FROM MISTAKES, OMISSIONS, OR DELAYS IN TRANSMISSION OF INFORMATION, OR FROM INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS, VIRUSES OR FAILURES OF PERFORMANCE, OR FROM THE IMPACT OF THE USE ON YOUR SYSTEM. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. THE List - MRI Safety LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Aortic Valved Graft (AVG), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, 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. 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.
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