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). Heart Valves Surgical Eur J Cardiothorac Surg. Indications, Safety, and Warnings. Eur J Cardiothorac Surg. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. 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. 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. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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). Healthcare Professionals Please consult the approved indications for use. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. If not approved, please exit this site. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Fifteen years of experience with ATS mechanical heart valve prostheses. Products Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. J Heart Valve Dis. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Technical Support. Advancing the Technology of Bileaflet Mechanical HeartValves. Safety Topic / Subject Article Text 179: . Update my browser now. 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 has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Email: Corporate.UDI@medtronic.com CLOSE . 2001; 4(4):346-353. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Legal Compliance. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. Indications for Use The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, or malfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Patients Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 3: Conditional 5 More. Contraindications: None known . Van Nooten GJ, Caes F, Francois K, et al. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Aortic Valved Graft (AVG), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, 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. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Important Safety Information. F 708.478.3519. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. 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. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: 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. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Open Pivot Mechanical Heart Valve. 2,3 . Cardiovascular 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. ) Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. J Thorac Cardiovasc Surg. Products For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Permissions. (4) Hassler M, et al. The valve itself was correctly labeled as Mitral. Security/Privacy of Patient Data. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Technical Support. Premarket Approval (PMA). Home Open Pivot Aortic Valved Graft. The Medtronic Open Pivot AP360, AP, and Standard valves provide exceptional implantability, performance, and durability.1-3, Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. If you continue, you may go to a site run by someone else. NayaMed International Srl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Srl. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. The Suture Superstore that provides surgical disposables, sutures & more. The adverse events potentially associated with the use of prosthetic aortic heart 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. 1996; 2(1):51-58. Click OK to confirm you are a Healthcare Professional. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) 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. 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. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Disclaimer: This page may include information about products that may not be available in your region or country. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. 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. 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. J Heart Valve Dis. 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). 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. Premarket Approval (PMA). Update my browser now. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. The content may not be approved for use in your specific region or country. , chronic renal failure, hyperparathyroidism). For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. 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. Central/Eastern Europe, Middle East & Africa, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement, Supra-annular compact cuff configuration for excellent suturability and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic and mitral 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. 2010;139:1494-1500. 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. what happened in 1906 in europe Open Pivot Mechanical Heart Valves. Heart Valve Replacement - Surgical Conclusion: The Medtronic Open Pivot valved conduit is a safe and durable option for aortic root replacement, and is associated with low morbidity and 10-year survival of 79%. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Active Remote Viewer as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software. Advancing the Technology of Bileaflet Mechanical HeartValves. Five-year follow up of the ATS mechanical heart valve. Miscellaneous. Cardiovascular It is possible that some of the products on the other site are not approved in your country. U.S. Food & Drug Administration. Home With an updated browser, you will have a better Medtronic website experience. Int J Artif Organs. Ann Thorac Cardiovasc Surg. Phone Numbers. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. March 2004;13(2):231-238. Note: Manuals can be viewed using a current version of any major internet browser. Indications, Safety, & Warnings. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. More R and Haubold A. Single-plane orifice facilitates valve seating and implant regardless of suture technique. It is possible that some of the products on the other site are not approved in your region or country. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Update my browser now. Healthcare Professionals 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. MEDTRONIC ATS MEDICAL . P 844-SUTURES (788-8737) P 888.416.2409. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU FOR INTERCEPTION OR COMPROMISE OF ANY INFORMATION OR FOR ANY RECORD OR OTHER COMMUNICATION PROVIDED IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. U.S. Food & Drug Administration. 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 ]. Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) 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.

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