You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Cell Mater. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Your Personal Information. 2000;69:507-512. Potential Adverse Events: Certain complications may occur with heart valve procedures. J Heart Valve Dis. If you continue, you may go to a site run by someone else. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 2009;18(4):445-452. 1996;10(8):660-665. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. This Agreement shall be in effect from the date when you first install or use the Licensed Software. 2004 Mar;13(2):231-238. LifeLine CardioVascular For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. LifeLine CardioVascular J Vasc Surg. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 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. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 1996;6: 273-79. With an updated browser, you will have a better Medtronic website experience. This site is Exclusively Sponsored by BRACCO. 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. 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. Open Pivot Mechanical Heart Valves 3: . 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. Healthcare Professionals 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. Emery RW, Petersen RJ, Kersten TE, et al. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Open Pivot Aortic Valved Graft. 3: Conditional 5 More. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Indications, Safety, and Warnings - Medtronic Note: Manuals can be viewed using a current version of any major internet browser. Products Certain complications may occur with heart valve procedures. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. 2000;69:507-512. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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. Long-term outcomes following Medtronic Open Pivot valved conduit Update my browser now. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. The reoperation rate was 1.2%. 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. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Home 505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. . Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Premarket Approval (PMA) Cardiovascular 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. Healthcare Professionals You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. 2,9,10 Early results. It is possible that some of the products on the other site are not approved in your country. MEDTRONIC ATS MEDICAL . Cardiovascular Contraindications: None known . Home Please consult the approved indications for use. Heart Valves and Annuloplasty Rings More. 2,3 . It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. , chronic renal failure, hyperparathyroidism). The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Emery RW, Van Nooten GJ, Tesar PJ. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. J Radiol 1986;67:661-666. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Shiono M, Sezai Y, Sezai A, et al. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Five-year follow up of the ATS mechanical heart valve. Email: Corporate.UDI@medtronic.com CLOSE . 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. Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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