medtronic open pivot heart valve mri safety

Open Pivot valves are remarkably quiet.7,10. 1996;2(1):51-58. Legal Compliance. Home Update my browser now. Products 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. With an updated browser, you will have a better Medtronic website experience. 1.5, 3: 2001; 4(4):346-353. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. 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. Accessed April 20, 2021. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Heart Valve Replacement - Surgical Disclaimer: This page may include information about products that may not be available in your region or country. With an updated browser, you will have a better Medtronic website experience. Update my browser now. 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. Van Nooten GJ, Caes F, Francois K, et al. Update my browser now. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Healthcare Professionals Your Personal Information. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Sezai A, Hata M, Niino T, et al. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Int J Artif Organs. F 708.478.3519. Van Nooten GJ, Caes F, Francois K, et al. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. With an updated browser, you will have a better Medtronic website experience. In: Krian A, Matloff JM, Nicoloff DM, eds. what happened in 1906 in europe Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. Permissions. 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. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 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. 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. November 1999;22(11):754-763. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. 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. Medtronic Open Pivot Aortic Valved Graft (AVG) Indications: The Medtronic Open Pivot Aortic Valved Graft is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required. 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. J Heart Valve Dis. 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. 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. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Healthcare Professionals All information that you provide in connection with such registration must be complete, accurate, and truthful. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. U.S. Food & Drug Administration. 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. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. 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. Ann Thorac Surg. 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. ) Products Sezai A, Shiono M, Orime Y, et al. 1996;10(8):660-665. In addition, upon Medtronics request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction. 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 . 25 November 2022 0 Comments. The reoperation rate was 1.2%. 2000;69:507-512. March 1993;17(3):538-545. 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. 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%. Shiono M, Sezai Y, Sezai A, et al. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Home Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Products You just clicked a link to go to another website. 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. ) Active Remote Users. Home Please review applicable product labeling for your country for indications and instructions prior to use. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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. It is possible that some of the products on the other site are not approved in your country. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 1996;10(8):660-665. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Open Pivot Aortic Valved Graft. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Premarket Approval (PMA). CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Open Pivot Mechanical Heart Valves. 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. Heart Valves and Annuloplasty Rings More. Tex Heart Inst J. 2001;4(4):346-352. Cardiovascular . 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. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Home Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. With an updated browser, you will have a better Medtronic website experience. The valve itself was correctly labeled as Mitral. Krian A. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. 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. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Healthcare Professionals Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Products Home Heart Surg Forum. Premarket Approval (PMA). Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. 2010;139:1494-1500. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Note: Manuals can be viewed using a current version of any major internet browser. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. J Radiol 1986;67:661-666. Miscellaneous. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. March 2004;13(2):231-238. 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. Open Pivot Mechanical Heart Valve. Surgical Heart Valve Repair and Replacement 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. 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 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. ) Heart Valves Surgical Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Update my browser now. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. LifeLine CardioVascular Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. At any time upon Medtronics request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. March 2004;13(2):231-238. The user name and password are personal to you and must not be shared with anyone else. 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. Update my browser now. Ann Thorac Surg. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 2000;69:507-512. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 2003;75(2):444-452. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Krian A. 6-8 Outstanding Durability 3: . It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Limitations of Liability. LifeLine CardioVascular Healthcare Professionals View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Even very old stainless steel valves are likewise considered of no danger in MRI. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card 1996(10):660-665. 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 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. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Emery RW, Petersen RJ, Kersten TE, et al. Note: Manuals can be viewed using a current version of any major internet browser. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. 1999; 22:754-763. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. 2001;4(4):346-352. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. on x prosthetic heart valve ascending aortic proth. 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. Clinical results of a large series of ATS valve implants. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Important Safety Information. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart Valves Surgical 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. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. 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. The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 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. J Thorac Cardiovasc Surg. U.S. Food & Drug Administration. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. 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 agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. 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). 1996; 2(1):51-58. Technical Support. LifeLine CardioVascular Accessed April 20, 2021. 2009;18(4):445-452. 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. Ann Thorac Surg. This device may be used to replace a previously implanted prosthetic heart valve or conduit. Fifteen years single-center experience with the ATS bileaflet valve. Fifteen years single-center experience with the ATS bileaflet valve. 2004 Mar;13(2):231-238. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Indications, Safety, and Warnings. With an updated browser, you will have a better Medtronic website experience. 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. 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. Treatments & Therapies

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