LifeLine CardioVascular Limited License Grant. J Vasc Surg. Int J Artif Organs. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Medtronic Open Pivot Heart Valve Instructions for Use. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 6-8 Outstanding Durability Accessed April 20, 2021. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. March 2004;13(2):231-238. Please consult the approved indications for use. Potential Adverse Events: Certain complications may occur with heart valve procedures. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. 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. Emery RW, Petersen RJ, Kersten TE, et al. 1996;10(8):660-665. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Healthcare Professionals You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. 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. J Heart Valve Dis. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. MEDTRONIC ATS MEDICAL . You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) With an updated browser, you will have a better Medtronic website experience. Single-plane orifice facilitates valve seating and implant regardless of suture technique. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Cardiovascular 1996;2(1):51-58. 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. 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). Emery RW, Krogh CC, Jones DJ, et al. All information that you provide in connection with such registration must be complete, accurate, and truthful. Indications, Safety, & Warnings. 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). With an updated browser, you will have a better Medtronic website experience. Heart Valves Surgical Home Shiono M, Sezai Y, Sezai A, et al. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS In: Krian A, Matloff JM, Nicoloff DM, eds. In the event that any provision of this Agreement violates any applicable statute, ordinance, or rule of law, such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement. Home Patients Update my browser now. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Availability. 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. Healthcare Professionals Accelerated structural deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, or hyperparathyroidism). Heart Valves Surgical 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. J Radiol 1986;67:661-666. U.S. Food & Drug Administration. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. Healthcare Professionals For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 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. If not approved, please exit this site. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement, Medtronic Open Pivot Aortic Valved Graft, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Note: Manuals can be viewed using a current version of any major internet browser. Emery RW, Van Nooten GJ, Tesar PJ. Emery RW, Petersen RJ, Kersten TE, et al. Open Pivot Mechanical Heart Valves. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Home Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. Open Pivot Mechanical Heart Valves Update my browser now. Contraindications: None known . Therapies & Procedures 1999; 22:754-763. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Open Pivot Aortic Valved Graft Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 2009;18(4):445-452. Eur J Cardiothorac Surg. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. 2009;18(4):445-452. Medtronic Open Pivot Heart Valve Instructions for Use. More than 140,000 valves have been implanted worldwide. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Ann Thorac Cardiovasc Surg. Emery RW, Van Nooten GJ, Tesar PJ. 25 November 2022 0 Comments. Open Pivot Mechanical Heart Valves. 1996;10(8):660-665. 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. The valve itself was correctly labeled as Mitral. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. With an updated browser, you will have a better Medtronic website experience. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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. 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. Fifteen years single-center experience with the ATS bileaflet valve. 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 Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Important Labeling Information for United States. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Open Pivot Aortic Valved Graft. Your Acknowledgements. 2000;69:507-512. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Home If you continue, you may go to a site run by someone else. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Cardiovascular 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 2001;4(4):346-352. Technical Support. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. 3: . Reporting Issues and Feedback. It is possible that some of the products on the other site are not approved in your country. 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. Technical Support. 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. 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 ]. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. 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. ) November 1999;22(11):754-763. Washington D.C.: U.S. Food and Drug Administration; 2000. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Sezai A, Shiono M, Orime Y, et al. The user name and password are personal to you and must not be shared with anyone else. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. March 2004;13(2):231-238. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Session Key. Emery RW, Petersen RJ, Kersten TE, et al. Heart Valves Surgical 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. Heart Valves Surgical Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. F 708.478.3519. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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. 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. Update my browser now. 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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. 1996;2(1):51-58. Premarket Approval (PMA). Eur J Cardiothorac Surg. Five-year follow up of the ATS mechanical heart valve. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. MRI Resources, For clinicians whose patients have a Medtronic system. Sezai A, Shiono M, Orime Y, et al. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Healthcare Professionals 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. 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. Accessed April 20, 2021. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Heart Valve Replacement - Surgical This site is Exclusively Sponsored by BRACCO. 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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