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. 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. 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. Update my browser now. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. Click OK to confirm you are a Healthcare Professional. MEDTRONIC ATS MEDICAL . When im-planted in the aortic position there were only . Shiono M, Sezai Y, Sezai A, et al. Email: Corporate.UDI@medtronic.com CLOSE . Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Five-year follow up of the ATS mechanical heart valve. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 2,3 . Open Pivot Mechanical Heart Valve. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 With an updated browser, you will have a better Medtronic website experience. Miscellaneous. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Heart Surg Forum. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Krian A. Ann Thorac Surg. Emery RW, Petersen RJ, Kersten TE, et al. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. You shall at all times use the Licensed Software in compliance with all applicable laws. 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. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Products The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 2000;69:507-512. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. 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. 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 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. The parties hereby expressly waive any right to a trial by jury or class treatment of any claim, demand, action, or cause of action arising out of or relating to the Licensed Software or this Agreement. 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. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. 1996;2(1):51-58. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser. 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. Surface chemistry and surface roughness of clinical pyrocarbons. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Technical Support. Emery RW, Petersen RJ, Kersten TE, et al. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 2009;18(4):445-452. Emery RW, Van Nooten GJ, Tesar PJ. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Sezai A, Hata M, Niino T, et al. 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. 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%. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Heart Valve Replacement - Surgical The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. J Heart Valve Dis. 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. ) Healthcare Professionals MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Term, Termination, Modifications, and Support. With an updated browser, you will have a better Medtronic website experience. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. J Heart Valve Dis. Eur J Radiol 1992;2:555-558. 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). , chronic renal failure, hyperparathyroidism). Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. 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. Cardiovascular Technical Support. 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. By installing or using the Licensed Software to view the Programmer screen information, registering a username and password in connection with the Medtronic RemoteView feature, or clicking on any acceptance button in connection herewith, you, a Remote Viewer, agree to be bound by all of the terms and conditions set forth in these Terms of Use (this Agreement). Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Ann Thorac Surg. . 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Proven Graft Material By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User: ) Registration. 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. However, further studies are required to determine the effect of valve gradient on survival. Van Nooten GJ, Caes F, Francois K, et al. Heart Valves and Annuloplasty Rings More. LifeLine CardioVascular Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Active Remote Viewer as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Fifteen years single-center experience with the ATS bileaflet valve. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Therapies & Procedures Premarket Approval (PMA). 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. 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. All information that you provide in connection with such registration must be complete, accurate, and truthful. Eur J Cardio-thorac Surg. 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. Cardiovascular 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). This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS 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. data, and the Medtronic valves are no exception. Limited License Grant. Heart Surg Forum. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. 2001;4(4):346-352. 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. 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. In: Krian A, Matloff JM, Nicoloff DM, eds. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Heart Valves Surgical Surgical Heart Valve Repair and Replacement Active Remote Users. Emery RW, Krogh CC, Jones DJ, et al. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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. 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. Important Labeling Information for United States. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Five-year follow up of the ATS mechanical heart valve. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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, 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 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Availability. 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. Cardiovascular A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Clinical results of a large series of ATS valve implants. 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. Open Pivot valves are remarkably quiet.7,10. November 1999;22(11):754-763. 3: Conditional 5 More. 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. Accessed April 20, 2021. 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. Home 1996;10(8):660-665. 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. Single-plane orifice facilitates valve seating and implant regardless of suture technique. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. The initial United States experience with the ATS mechanical cardiac valve prosthesis. 3: . In: Krian A, Matloff JM, Nicoloff DM, eds. 2003;75(2):444-452. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Products Potential Adverse Events: Certain complications may occur with heart valve procedures. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M March 2004;13(2):231-238. With an updated browser, you will have a better Medtronic website experience. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Treatments & Therapies Healthcare Professionals 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. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 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. Reporting Issues and Feedback. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. With an updated browser, you will have a better Medtronic website experience. Security/Privacy of Patient Data. Emery RW, Petersen RJ, Kersten TE, et al. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The valve itself was correctly labeled as Mitral. This site is Exclusively Sponsored by BRACCO. Thus, a patient with any heart valve prosthesis listed in Table 1 undergoing an MRI procedure using an MR system operating at 1.5 T or less would not be at risk with regard to movement or dislodgement of the implant. Advancing the Technology of Bileaflet Mechanical HeartValves. Krian A. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Safety Topic / Subject Article Text 179: . 2010;139:1494-1500. 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. Accessed April 20, 2021. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Contraindications: None known . 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 use of the other site is subject to the terms of use and privacy statement on that site. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Note: Manuals can be viewed using a current version of any major internet browser. Five-year follow up of the ATS mechanical heart valve. New York: Springer Verlag; 1998:53-71. Sezai A, Shiono M, Orime Y, et al. 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. 2004 Mar;13(2):231-238. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. 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. Open Pivot Mechanical Heart Valves. Advancing the Technology of Bileaflet Mechanical HeartValves. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Home Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Heart Valves Surgical To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password.
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