Heart Valves and Annuloplasty Rings More. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. J Heart Valve Dis. Five-year follow up of the ATS mechanical heart valve. 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. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Open Pivot Aortic Valved Graft. 3: Conditional 5 More. Heart Surg Forum. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. MRI Resources, For clinicians whose patients have a Medtronic system. Accessed April 20, 2021. 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. Open Pivot valves are remarkably quiet.7,10. If you continue, you may go to a site run by someone else. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. 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. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. J Heart Valve Dis. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Important Labeling Information for United States. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Please consult the approved indications for use. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Premarket Approval (PMA). LifeLine CardioVascular Update my browser now. With an updated browser, you will have a better Medtronic website experience. 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. , chronic renal failure, hyperparathyroidism). Clinical results of a large series of ATS valve implants. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, 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. Cardiovascular Home Please review applicable product labeling for your country for indications and instructions prior to use. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: 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. Emery RW, Van Nooten GJ, Tesar PJ. 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. All information that you provide in connection with such registration must be complete, accurate, and truthful. Warnings/Precautions/Adverse Events 2004 Mar;13(2):231-238. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Medtronic Open Pivot Heart Valve Instructions for Use. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Products Logging of Session Activity. 1996; 2(1):51-58. Ann Thorac Surg. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Healthcare Professionals 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. 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. ) A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 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. J Heart Valve Dis. With an updated browser, you will have a better Medtronic website experience. Even very old stainless steel valves are likewise considered of no danger in MRI. The leaflets are made of solid pyrolytic carbon with a thin titanium band. 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 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. Open Pivot Mechanical Heart Valve. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. It is possible that some of the products on the other site are not approved in your country. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Potential Adverse Events: Certain complications may occur with heart valve procedures. 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). CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. With an updated browser, you will have a better Medtronic website experience. F 708.478.3519. 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. Permissions. With an updated browser, you will have a better Medtronic website experience. 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. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Indications, Safety, & Warnings. The parties hereby expressly waive any right to a trial by jury or class treatment of any claim, demand, action, or cause of action arising out of or relating to the Licensed Software or this Agreement. Int J Artif Organs. 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. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Important Safety Information. on x prosthetic heart valve ascending aortic proth. 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. J Heart Valve Dis. Accessed April 20, 2021. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. Cardiovascular Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Healthcare Professionals November 1999;22(11):754-763. In: Krian A, Matloff JM, Nicoloff DM, eds. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS LifeLine CardioVascular 2000;69:507-512. Products Certain complications may occur with heart valve procedures. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Shiono M, Sezai Y, Sezai A, et al. 2001; 4(4):346-353. 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 Surg. Heart Valves Surgical You just clicked a link to go to another website. Products 2001;4(4):346-352. Healthcare Professionals This Agreement shall be governed by and interpreted, construed, and enforced in accordance with the laws of the State of Minnesota (exclusive of the choice of law rules thereof). Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Emery RW, Krogh CC, Jones DJ, et al. 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. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. 2001;4(4):346-352. 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. Cell Mater. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Active Remote Users. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Open Pivot Aortic Valved Graft 25 November 2022 0 Comments. More than 140,000 valves have been implanted worldwide. 1996;6: 273-79. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 2003;75(2):444-452. (4) Hassler M, et al. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Medtronic Open Pivot Aortic Valved Graft (AVG), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification.

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