Five-year follow up of the ATS mechanical heart valve. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 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. Van Nooten GJ, Caes F, Francois K, et al. 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. MeSH terms Adolescent Adult Aged Aorta / surgery* New York: Springer Verlag; 1998:53-71. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. THE List - MRI Safety Home The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Ann Thorac Cardiovasc Surg. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Proven Graft Material Note: Manuals can be viewed using a current version of any major internet browser. Shiono M, Sezai Y, Sezai A, et al. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 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. Washington D.C.: U.S. Food and Drug Administration; 2000. Open Pivot Aortic Valved Graft Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) 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. 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. 1999; 22:754-763. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Indications, Safety, and Warnings. Ats Medical Heart Valve Mri Safety | Day of Difference Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. ) Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. 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. FDA Determined Cause 2: Labeling mix-ups . Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. 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. ) If you continue, you may go to a site run by someone else. Five-year follow up of the ATS mechanical heart valve. data, and the Medtronic valves are no exception. THE List - MRI Safety Home 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 Potential Adverse Events: Certain complications may occur with heart valve procedures. J Heart Valve Dis. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Phone Numbers. 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 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%. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Premarket Approval (PMA). Home Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Cardiovascular 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. Certain complications may occur with heart valve procedures. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. MRI Resources, For clinicians whose patients have a Medtronic system. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. LifeLine CardioVascular Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft 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. Home Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship 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. Shiono M, Sezai Y, Sezai A, et al. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 2003;75(2):444-452. J Heart Valve Dis. Heart Surg Forum. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. More R and Haubold A. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Medtronic Open Pivot Heart Valves Product Specifications medtronic open pivot Standard Heart valve Aortic Standard Tissue Annulus Orifice Inner Geometric Valve Size Model Diameter (B) Diameter (A) Orifice Area (mm) Number (mm) (mm) (cm2) 19 500FA19 19.5 14.8 1.55 21 500FA21 21.5 16.8 2.02 23 500FA23 23.5 18.8 2.56 With an updated browser, you will have a better Medtronic website experience. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. ) J Heart Valve Dis. September 1993;106(3):427-433. Aortic and Mitral Valve Replacement Emery RW, Petersen RJ, Kersten TE, et al. 1996(10):660-665. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Clinical results of a large series of ATS valve implants. It is possible that some of the products on the other site are not approved in your country. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Advanced Discussion (show/hide) References 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 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. Update my browser now. 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. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Cardiovascular Update my browser now. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Shiono M, Sezai Y, Sezai A, et al. 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. Healthcare Professionals 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Safety Topic/Article: 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. 2,9,10 MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Click Continue to close this window and view the sites content. Prosthetic heart valves: Evaluation of magnetic field interactions 1996;6: 273-79. Int J Artif Organs. U.S. Food & Drug Administration. 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. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Cardiovascular Emery RW, Petersen RJ, Kersten TE, et al. With an updated browser, you will have a better Medtronic website experience. 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. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. U.S. Food & Drug Administration. J Heart Valve Dis. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. MR safety: cardiac valves - Questions and Answers in MRI Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Indications, Safety, and Warnings - Open Pivot Mechanical Heart Valves Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Heart Valve Replacement - Surgical Your use of the other site is subject to the terms of use and privacy statement on that site. 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. AccessGUDID - DEVICE: Open Pivot (00613994960412) MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation.