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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. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. 2001;4(4):346-352. More R and Haubold A. 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. 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. Important Safety Information. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. J Thorac Cardiovasc Surg. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Technical Support. 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. Open Pivot Mechanical Heart Valve, Medtronic Open Pivot Mechanical Heart Valves, While mechanical valves have been used for heart valve replacement for nearly 50 years, the Medtronic Open Pivot platform brings a fundamentally different design to bileaflet mechanical valves. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Heart Valves Surgical The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Sezai A, Hata M, Niino T, et al. Emery RW, Petersen RJ, Kersten TE, et al. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. 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. what happened in 1906 in europe ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 1996;10(8):660-665. 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. . 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. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 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. 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. Clinical results of a large series of ATS valve implants. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Warnings/Precautions/Adverse Events Medtronic Open Pivot Heart Valve Instructions for Use. Therapies & Procedures Note: Manuals can be viewed using a current version of any major internet browser. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. 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. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 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. 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 Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Five-year follow up of the ATS mechanical heart valve. U.S. Food & Drug Administration. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Update my browser now. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 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. Open Pivot Mechanical Heart Valves. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Click OK to confirm you are a Healthcare Professional. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Active Remote Users. Premarket Approval (PMA). MEDTRONIC ATS MEDICAL . Potential Adverse Events: Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism. Products Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 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. Products The initial United States experience with the ATS mechanical cardiac valve prosthesis. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: data, and the Medtronic valves are no exception. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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. 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. Home Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card 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. 2003;75(2):444-452. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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). Int J Artif Organs. , chronic renal failure, hyperparathyroidism). With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Shiono M, Sezai Y, Sezai A, et al. Ann Thorac Surg. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Heart Valves and Annuloplasty Rings More. 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). 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. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. 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). Effects of magnetic fields used in MRI on 15 prosthetic heart valves. 2000;69:507-512. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Phone Numbers. Note: Manuals can be viewed using a current version of any major internet browser. Update my browser now. Clinical results of a large series of ATS valve implants. Legal Compliance. November 1999;22(11):754-763. 2003;75(2):444-452. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. Cardiovascular Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. F 708.478.3519. 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. Ann Thorac Surg. Five-year follow up of the ATS mechanical heart valve. With an updated browser, you will have a better Medtronic website experience. 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. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. . Technical Support. 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 For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. It is possible that some of the products on the other site are not approved in your country. J Heart Valve Dis. Krian A. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. 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. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Van Nooten GJ, Caes F, Francois K, et al. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Heart Valves Surgical Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. J Thorac Cardiovasc Surg. Emery RW, Petersen RJ, Kersten TE, et al. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Advanced Discussion (show/hide) References J Heart Valve Dis. Advancing the Technology of Bileaflet Mechanical HeartValves. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals.