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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 MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Cardiovascular 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. 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. New York: Springer Verlag; 1998:53-71. Premarket Approval (PMA). Fifteen years of experience with ATS mechanical heart valve prostheses. Healthcare Professionals Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Click Continue to close this window and view the sites content. 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. Heart Surg Forum. 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. 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. Note: Manuals can be viewed using a current version of any major internet browser. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. 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. In: Krian A, Matloff JM, Nicoloff DM, eds. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Accessed April 20, 2021. Emery RW, Petersen RJ, Kersten TE, et al. Five-year follow up of the ATS mechanical heart valve. 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. J Heart Valve Dis. Open Pivot Mechanical Heart Valves. Healthcare Professionals For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. U.S. Food & Drug Administration. Contraindications: None known . Ann Thorac Cardiovasc Surg. 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. 3: Conditional 5 More. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. 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. 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). Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Van Nooten GJ, Caes F, Francois K, et al. Security/Privacy of Patient Data. Miscellaneous. 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. In: Krian A, Matloff JM, Nicoloff DM, eds. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. , chronic renal failure, hyperparathyroidism). 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. The valve itself was correctly labeled as Mitral. Healthcare Professionals 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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. Ann Thorac Cardiovasc Surg. Five-year follow up of the ATS mechanical heart valve. Treatments & Therapies Email: Corporate.UDI@medtronic.com CLOSE . Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. MEDTRONIC ATS MEDICAL . 1.5, 3: 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. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Products 1996;2(1):51-58. If you continue, you will leave this site and go to a site run by someone else. The initial United States experience with the ATS mechanical cardiac valve prosthesis. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. J Heart Valve Dis. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Ann Thorac Surg. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Heart Valves and Annuloplasty Rings More. 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). Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Ann Thorac Surg. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. 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. Aortic and Mitral Valve Replacement 1996;10(8):660-665. Shiono M, Sezai Y, Sezai A, et al. Heart Valves Surgical The initial experience with the ATS Medical mechanical cardiac valve prosthesis. J Heart Valve Dis. Washington D.C.: U.S. Food and Drug Administration; 2000. 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 Emery RW, Petersen RJ, Kersten TE, et al. Note: Manuals can be viewed using a current version of any major internet browser. 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. ) Atriasept Closure DeviceCardia, Inc.Eagan, MN, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., Lake Forrest, CA, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., www.navigatecsi.com, Atrix-C Cervical Allograft Interbody SpacerXtant Medical, www.xtantmedical.com, Atrostim Phrenic Nerve StimulatorASTROTECH OYTampere, Finland, ATS 3f Enable Aortic BioprosthesisModel 6000ATS Medical, Inc.Lake Forest, CA, ATS Medical Open PivotAortic Valved GraftModel # XX denotes size502AGxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAortic, Model 501DA18Advanced Performance (AP)pyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 AorticModel # XX denotes size505DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 MitralModel # XX denotes size505DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP AorticModel # XX denotes size501DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP MitralModel # XX denotes size501DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex AorticModel # XX denotes size503DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex MitralModel # XX denotes size503DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveMitral, Model 500DM29Standard Valvepyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard AorticModel # XX denotes size500FAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard MitralModel # XX denotes size500DMxxATS MedicalMinneapolis, M, ATTRACTOR Screw17-4 SSPorex Surgical, Newnan, GA, Attune Flexible Annuloplasty RingSt. 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. Products Technical Support. More R and Haubold A. 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. 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: J Heart Valve Dis. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Shiono M, Sezai Y, Sezai A, et al. 2,3 . 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. Term, Termination, Modifications, and Support. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. September 1993;106(3):427-433. Note: Manuals can be viewed using a current version of any major internet browser. 1996;6: 273-79. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. 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. ) 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. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. 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. 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 ].