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. 2003;75(2):444-452. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Heart Surg Forum. 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. With an updated browser, you will have a better Medtronic website experience. Legal Compliance. Ann Thorac Surg. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Five-year follow up of the ATS mechanical heart valve. Shiono M, Sezai Y, Sezai A, et al. 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 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. The valve itself was correctly labeled as Mitral. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. Disclaimer: This page may include information about products that may not be available in your region or country. Click OK to confirm you are a Healthcare Professional. Patients On-X Life Technologies, Inc. P000037 S059: 03/24/2022: 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. 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. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. LifeLine CardioVascular Limited License Grant. 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. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. 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. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. 1996;2(1):51-58. on x prosthetic heart valve ascending aortic proth. 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Eur J Cardiothorac Surg. Ann Thorac Cardiovasc Surg. Premarket Approval (PMA). 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). Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. 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. ) 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. Cardiovascular Security/Privacy of Patient Data. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Home Van Nooten GJ, Caes F, Francois K, et al. New York: Springer Verlag; 1998:53-71. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Open Pivot Aortic Valved Graft. You just clicked a link to go to another website. Advanced Discussion (show/hide) References Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories 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. Update my browser now. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. If not approved, please exit this site. 2001;4(4):346-352. . MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. The initial United States experience with the ATS mechanical cardiac valve prosthesis. J Heart Valve Dis. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. Update my browser now. 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). The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. All information that you provide in connection with such registration must be complete, accurate, and truthful. U.S. Food & Drug Administration. Krian A. With an updated browser, you will have a better Medtronic website experience. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Five-year follow up of the ATS mechanical heart valve. November 1999;22(11):754-763. 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. With an updated browser, you will have a better Medtronic website experience. Clinical results of a large series of ATS valve implants. 3: . New York: Springer Verlag; 1998:53-71. 1996; 2(1):51-58. 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. 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. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Clinical results of a large series of ATS valve implants. Emery RW, Petersen RJ, Kersten TE, et al. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Contraindications: None known . Ann Thorac Surg. J Heart Valve Dis. 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 Products J Vasc Surg. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart Valve Replacement - Surgical 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. It is possible that some of the products on the other site are not approved in your region or country. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. With an updated browser, you will have a better Medtronic website experience. Note: Manuals can be viewed using a current version of any major internet browser. 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. 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 Note: Manuals can be viewed using a current version of any major internet browser. Cardiovascular Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Active Remote Users. FDA Determined Cause 2: Labeling mix-ups . Int J Artif Organs. J Radiol 1986;67:661-666. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Emery RW, Van Nooten GJ, Tesar PJ. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Term, Termination, Modifications, and Support. Early results. Your Personal Information. 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. 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. Ann Thorac Cardiovasc Surg. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. 2010;139:1494-1500. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 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. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. 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. Int J Artif Organs. 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 Home These improvements led to low thromboembolic rates of 1.25% per patient year and encouraged a reduction in anticoagulation treatment to an INR of 1.5 to 2.5 in isolated aortic valve replacement cases [ 179 ]. Medtronic Open Pivot Heart Valve Instructions for Use. With an updated browser, you will have a better Medtronic website experience. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Surgical Heart Valve Repair and Replacement Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. Washington D.C.: U.S. Food and Drug Administration; 2000. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, infection other than endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 2003;75(2):444-452. It is possible that some of the products on the other site are not approved in your country. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Availability. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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 . Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Int J Artif Organs. 2009;18(4):445-452. Sezai A, Shiono M, Orime Y, et al. Van Nooten GJ, Caes F, Francois K, et al. Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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 countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Eur J Cardiothorac Surg. 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. ) Medtronic may modify, disable, or terminate your use or Medtronics support of the Licensed Software at any time, including by providing notices on a Medtronic website. Open Pivot Mechanical Heart Valves Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. 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). Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. When im-planted in the aortic position there were only . Accessed April 20, 2021. Fifteen years single-center experience with the ATS bileaflet valve. Shiono M, Sezai Y, Sezai A, et al. 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. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. Aortic and Mitral Valve Replacement Even very old stainless steel valves are likewise considered of no danger in MRI. Healthcare Professionals Kelly SGD, Verdonck PR, Vierendeels JAM, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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 initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. Five-year follow up of the ATS mechanical heart valve. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. More than 140,000 valves have been implanted worldwide. Sezai A, Shiono M, Orime Y, et al. 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. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. 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 F 708.478.3519. 1996;10(8):660-665. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Ann Thorac Surg. Heart Valves and Annuloplasty Rings More. 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. Open Pivot Aortic Valved Graft 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. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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.
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