medtronic open pivot heart valve mri safety

Medtronic Open Pivot Heart Valve Instructions for Use. 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. Open Pivot Aortic Valved Graft. Emery RW, Petersen RJ, Kersten TE, et al. 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. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Heart Valves Surgical 2,9,10 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. 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. Accessed April 20, 2021. Update my browser now. Adverse events can include: angina, cardiac dysrhythmias, death, endocarditis, heart failure, hemolytic anemia, infection other than endocarditis, myocardial infarction, root dilatation, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Brand Name: Open Pivot Version or Model: 500FA23 Commercial Distribution Status: Not in Commercial Distribution Catalog Number: Company Name: MEDTRONIC, INC. Primary DI Number: 00613994960412 Issuing Agency: GS1 Commercial Distribution End Date: October 21, 2019 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use J Heart Valve Dis. Ann Thorac Surg. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. . MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. J Radiol 1986;67:661-666. Indications, Safety, and Warnings. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Disclaimer: This page may include information about products that may not be available in your region or country. J Thorac Cardiovasc Surg. 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. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Emery RW, Van Nooten GJ, Tesar PJ. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 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. Phone Numbers. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. The leaflets are made of solid pyrolytic carbon with a thin titanium band. New York: Springer Verlag; 1998:53-71. 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). 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Miscellaneous. 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. Healthcare Professionals Potential Adverse Events: Certain complications may occur with heart valve procedures. It is possible that some of the products on the other site are not approved in your region or country. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Open Pivot Aortic Valved Graft The content may not be approved for use in your specific region or country. Krian A. 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 . Shiono M, Sezai Y, Sezai A, et al. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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 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. Van Nooten GJ, Caes F, Francois K, et al. 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. 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. 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. Eur J Radiol 1992;2:555-558. The valve itself was correctly labeled as Mitral. 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. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Home Open Pivot Mechanical Heart Valves Eur J Cardiothorac Surg. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. 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. 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. 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). 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. 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. 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. 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. 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. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Click OK to confirm you are a Healthcare Professional. Note: Manuals can be viewed using a current version of any major internet browser. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Medtronic Open Pivot Heart Valve Instructions for Use. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. March 2004;13(2):231-238. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. New York: Springer Verlag; 1998:53-71. 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. Heart Surg Forum. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Note: Manuals can be viewed using a current version of any major internet browser. Heart Valves Surgical For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Fifteen years of experience with ATS mechanical heart valve prostheses. Sezai A, Hata M, Niino T, et al. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Therapies & Procedures J Heart Valve Dis. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. 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. 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. 1999; 22:754-763. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Fifteen years single-center experience with the ATS bileaflet valve. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Emery RW, Petersen RJ, Kersten TE, et al. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Ann Thorac Surg. Products These improvements led to low thromboembolic rates of 1.25% per patient year and encouraged a reduction in anticoagulation treatment to an INR of 1.5 to 2.5 in isolated aortic valve replacement cases [ 179 ]. Medtronic, 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 Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. 1996;10(8):660-665. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. March 2004;13(2):231-238. Open Pivot valves are remarkably quiet.7,10. 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). Note: Manuals can be viewed using a current version of any major internet browser. However, further studies are required to determine the effect of valve gradient on survival. Warnings/Precautions/Adverse Events