For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Int J Artif Organs. Note: Manuals can be viewed using a current version of any major internet browser. Home NayaMed International Srl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Srl. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information. ) Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Update my browser now. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 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 Home Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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 Certain complications may occur with heart valve procedures. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Aortic and Mitral Valve Replacement For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. Update my browser now. 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. Van Nooten GJ, Caes F, Francois K, et al. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Legal Compliance. Healthcare Professionals Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. 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. 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. J Radiol 1986;67:661-666. Premarket Approval (PMA). Krian A. September 1993;106(3):427-433. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Home J Heart Valve Dis. Even very old stainless steel valves are likewise considered of no danger in MRI. With an updated browser, you will have a better Medtronic website experience. Term, Termination, Modifications, and Support. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Fifteen years single-center experience with the ATS bileaflet valve. With an updated browser, you will have a better Medtronic website experience. Safety Topic / Subject Article Text 179: . 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. Home 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. You just clicked a link to go to another website. Update my browser now. MEDTRONIC ATS MEDICAL . You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. With an updated browser, you will have a better Medtronic website experience. J Vasc Surg. Clinical results of a large series of ATS valve implants. Active Remote Users. Heart Valves Surgical Krian A. The initial United States experience with the ATS mechanical cardiac valve prosthesis. , chronic renal failure, hyperparathyroidism). 1996; 2(1):51-58. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. March 2004;13(2):231-238. Eur J Radiol 1992;2:555-558. Accessed April 20, 2021. U.S. Food & Drug Administration. 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. Premarket Approval (PMA). J Heart Valve Dis. Heart Valve Replacement - Surgical Ann Thorac Surg. The initial United States experience with the ATS mechanical cardiac valve prosthesis. F 708.478.3519. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 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. Emery RW, Petersen RJ, Kersten TE, et al. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Home Premarket Approval (PMA). 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. Cardiovascular Accessed April 20, 2021. Ann Thorac Surg. Logging of Session Activity. 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). Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. You 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. Warnings/Precautions/Adverse Events Update my browser now. 2009;18(4):445-452. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Krian A. Indications, Safety, & Warnings. 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). New York: Springer Verlag; 1998:53-71. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Ann Thorac Surg. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS 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. Healthcare Professionals Surgical Heart Valve Repair and Replacement Int J Artif Organs. Cardiovascular Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. November 1999;22(11):754-763. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Security/Privacy of Patient Data. 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. Potential Adverse Events: Certain complications may occur with heart valve procedures. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Healthcare Professionals Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Heart Surg Forum. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. However, further studies are required to determine the effect of valve gradient on survival. 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 Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Ann Thorac Surg. MRI Resources, For clinicians whose patients have a Medtronic system. Five-year follow up of the ATS mechanical heart valve. 2006; 33: 154-159. 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. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Healthcare Professionals 1996;2(1):51-58. FDA Determined Cause 2: Labeling mix-ups . 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. Int J Artif Organs. 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. March 2004;13(2):231-238. J Thorac Cardiovasc Surg. 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. Note: Manuals can be viewed using a current version of any major internet browser. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. P990046 S062: 03/10/2022 Ann Thorac Surg. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. MeSH terms Adolescent Adult Aged Aorta / surgery* Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Note: Manuals can be viewed using a current version of any major internet browser. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 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. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. 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. The content may not be approved for use in your specific region or country. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Valves and Annuloplasty Rings More. Fifteen years single-center experience with the ATS bileaflet valve. Proven Graft Material 2,9,10 Click OK to confirm you are a Healthcare Professional. Technical Support. 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. Open Pivot Mechanical Heart Valves 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. The reoperation rate was 1.2%. Unique axis of suspension results in leaflet movement responsive to physiological demands; Gentle, passive washing ensures complete washing of the pivot in both open and closed positions; Most patients cannot hear the sound of their valve after implantation; Low levels of hemolysis and thromboembolic events Fifteen years of experience with ATS mechanical heart valve prostheses. Shiono M, Sezai Y, Sezai A, et al. Heart Valves Surgical 2001;4(4):346-352. All information that you provide in connection with such registration must be complete, accurate, and truthful. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card More than 140,000 valves have been implanted worldwide. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. 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. Important Labeling Information for United States. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Cardiovascular 2000;69:507-512. 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. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Emery RW, Van Nooten GJ, Tesar PJ. Therapies & Procedures You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. 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. Permissions. Ann Thorac Cardiovasc Surg. data, and the Medtronic valves are no exception. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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. Limited License Grant. 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. J Heart Valve Dis. 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. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. J Heart Valve Dis. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 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. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Healthcare Professionals 2003;75(2):444-452. 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. Technical Support. Eur J Cardio-thorac Surg. Heart Surgery Forum. With regard to any purported agreement or terms of use between you and Bomgar Corporation in connection with the Licensed Software (Bomgar EULA): (a) any Bomgar EULA shall be solely between you and Bomgar Corporation; (b) Medtronic shall not be a party to any Bomgar EULA; (c) any Bomgar EULA shall not necessarily reflect the contents of any agreement between Bomgar Corporation and Medtronic; (d) any Bomgar EULA shall not modify or take precedence over this Agreement; and (e) nothing in this Agreement shall be construed to suggest the enforceability or unenforceability of any Bomgar EULA. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. Indications, Safety, and Warnings. 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. Emery RW, Van Nooten GJ, Tesar PJ. November 1999;22(11):754-763. Sezai A, Shiono M, Orime Y, et al. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Clinical results of a large series of ATS valve implants. 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. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Home 1996;6: 273-79. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Your use of the other site is subject to the terms of use and privacy statement on that site. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. 3: Conditional 5 More. Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. 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.
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