Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. More than 140,000 valves have been implanted worldwide. 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. Van Nooten GJ, Caes F, Francois K, et al. 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. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you continue, you will leave this site and go to a site run by someone else. Security/Privacy of Patient Data. 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). Sezai A, Shiono M, Orime Y, et al. November 1999;22(11):754-763. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Washington D.C.: U.S. Food and Drug Administration; 2000. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. 1996;10(8):660-665. MR safety: cardiac valves - Questions and Answers in MRI The initial United States experience with the ATS mechanical cardiac valve prosthesis. Ann Thorac Surg. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. 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. 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. 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 just clicked a link to go to another website. U.S. Food & Drug Administration. 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. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. 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. 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. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. LifeLine CardioVascular Emery RW, Petersen RJ, Kersten TE, et al. J Thorac Cardiovasc Surg. Shiono M, Sezai Y, Sezai A, et al. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. 2003;75(2):444-452. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. You just clicked a link to go to another website. LifeLine CardioVascular MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. J Thorac Cardiovasc Surg. Emery RW, Van Nooten GJ, Tesar PJ. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. 6-8 Outstanding Durability Sezai A, Shiono M, Orime Y, et al. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Heart Valves - Surgical | Medtronic 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. 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 Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. 2000;69:507-512. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Long-term outcomes following Medtronic Open Pivot valved conduit These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. LifeLine CardioVascular Ann Thorac Cardiovasc Surg. Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. Accessed April 20, 2021. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Clinical results of a large series of ATS valve implants. 505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 to 26 mm for aortic 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. 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. Products Term, Termination, Modifications, and Support. THE List - MRI Safety Home Premarket Approval (PMA). Home Indications, Safety, & Warnings. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. medtronic open pivot - Cor-Medical Premarket Approval (PMA). Eur J Cardiothorac Surg. 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. J Heart Valve Dis. (4) Hassler M, et al. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. 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). For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Therapies & Procedures All information that you provide in connection with such registration must be complete, accurate, and truthful. Patients Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. ATS Medical Demo Mitral Valve | National Museum of American History 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, 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 Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Healthcare Professionals 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). Sezai A, Hata M, Niino T, et al. Emery RW, Petersen RJ, Kersten TE, et al. Van Nooten GJ, Caes F, Francois K, et al. Update my browser now. Note: Manuals can be viewed using a current version of any major internet browser. 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. Int J Artif Organs. Update my browser now. Fifteen years single-center experience with the ATS bileaflet valve. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Open Pivot Aortic Valved Graft Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Heart Valves Surgical 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 By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. 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. In: Krian A, Matloff JM, Nicoloff DM, eds. 1996;2(1):51-58. 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. 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. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. Update my browser now. 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. 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. 2010;139:1494-1500. Heart Surg Forum. Int J Artif Organs. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. March 2004;13(2):231-238. Krian A. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Premarket Approval (PMA) The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. In: Krian A, Matloff JM, Nicoloff DM, eds. 1.5, 3: Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. However, further studies are required to determine the effect of valve gradient on survival. Heart Valves and Annuloplasty Rings More. Prosthetic heart valves: Evaluation of magnetic field interactions ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Masters Mitral and Aortic Mechanical Valves | Abbott PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship This device may be used to replace a previously implanted prosthetic heart valve or conduit. F 708.478.3519. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. When im-planted in the aortic position there were only . With an updated browser, you will have a better Medtronic website experience. 3: . Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 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. Fifteen years of experience with ATS mechanical heart valve prostheses. 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Accessed April 20, 2021. Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 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 Miscellaneous. J Radiol 1986;67:661-666. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Disclaimer: This page may include information about products that may not be available in your region or country. Sezai A, Shiono M, Orime Y, et al. 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. Avalus Bioprosthesis - Surgical Heart Valves | Medtronic Heart Valves Surgical Note: Manuals can be viewed using a current version of any major internet browser. Emery RW, Krogh CC, Jones DJ, et al. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Heart Valve Design & Features - CryoLife, Inc. 2009;18(4):445-452. Active Remote Users. Heart Valve Replacement - Surgical It is possible that some of the products on the other site are not approved in your country. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Warnings/Precautions/Adverse Events You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. With an updated browser, you will have a better Medtronic website experience. Clinical results of a large series of ATS valve implants. 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. A recent publication from a single center in Belgium followed all patients with an Open Pivot valve im-planted over a 20 year period.81 In total, 1520 Open Pivot valves were implanted in 1382 consecutive patients with a 99% rate of follow-up. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Emery RW, Van Nooten GJ, Tesar PJ. 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. Your Acknowledgements. With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Limited License Grant. Emery RW, Petersen RJ, Kersten TE, et al. Van Nooten GJ, Caes F, Francois K, et al. Your Personal Information. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Safety Topic/Article: 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. 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. ) Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 2000;69:507-512. Fifteen years of experience with ATS mechanical heart valve - PubMed Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Clinical results of a large series of ATS valve implants. Phone Numbers. 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
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medtronic open pivot heart valve mri safety