Washington D.C.: U.S. Food and Drug Administration; 2000. J Heart Valve Dis. 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. 6-8 Outstanding Durability Update my browser now. 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). Update my browser now. Emery RW, Van Nooten GJ, Tesar PJ. what happened in 1906 in europe - switchedoneducationusa.com Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. Note: Manuals can be viewed using a current version of any major internet browser. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Cardiovascular PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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 All information that you provide in connection with such registration must be complete, accurate, and truthful. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. If not approved, please exit this site. 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. Session Key. 3: . Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Eur J Cardiothorac Surg. J Radiol 1986;67:661-666. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Cardiovascular Clinical results of a large series of ATS valve implants. 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. Int J Artif Organs. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. 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. 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 agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America. ) You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. When im-planted in the aortic position there were only . 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. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. This site is Exclusively Sponsored by BRACCO. Note: Manuals can be viewed using a current version of any major internet browser. You shall at all times use the Licensed Software in compliance with all applicable laws. Your use of the other site is subject to the terms of use and privacy statement on that site. 1996;10(8):660-665. Update my browser now. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU OR YOUR ASSOCIATED HOSPITAL, CLINIC, OR PRACTICE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE, SESSIONS KEYS, OR THESE TERMS OF USE (WHETHER IN WARRANTY, CONTRACT, TORT, OR OTHERWISE, INCLUDING NEGLIGENCE, AND EVEN IF MEDTRONIC HAS BEEN ADVISED OF THE POSSIBILITY THEREOF), INCLUDING WITHOUT LIMITATION MEDICAL EXPENSES, LOSS OF REVENUE OR PROFITS, OR DAMAGES RESULTING FROM LOSS, MISAPPROPRIATION, OR UNAUTHORIZED OR MALICIOUS ACCESS TO OR MODIFICATION OF DEVICE DATA, OR FROM MISTAKES, OMISSIONS, OR DELAYS IN TRANSMISSION OF INFORMATION, OR FROM INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS, VIRUSES OR FAILURES OF PERFORMANCE, OR FROM THE IMPACT OF THE USE ON YOUR SYSTEM. Int J Artif Organs. Update my browser now. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Tex Heart Inst J. 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. 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. 2003;75(2):444-452. 2009;18(4):445-452. Products 1996; 2(1):51-58. 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. If you continue, you will leave this site and go to a site run by someone else. Open Pivot Mechanical Heart Valves. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Premarket Approval (PMA). However, further studies are required to determine the effect of valve gradient on survival. Heart Surg Forum. Indications, Safety, & Warnings. 2000;69:507-512. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Clinical results of a large series of ATS valve implants. 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. New York: Springer Verlag; 1998:53-71. Premarket Approval (PMA) Note: Manuals can be viewed using a current version of any major internet browser. 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%. Home A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 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. Disclaimer: This page may include information about products that may not be available in your region or country. Ann Thorac Surg. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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). 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. ATS Medical Demo Mitral Valve | National Museum of American History 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. Heart Valves Surgical The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 2010;139:1494-1500. Eur J Radiol 1992;2:555-558. Your Acknowledgements. The Suture Superstore that provides surgical disposables, sutures & more. 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. Eur J Cardiothorac Surg. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Fifteen years single-center experience with the ATS bileaflet valve. With an updated browser, you will have a better Medtronic website experience. 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. ) Open Pivot Aortic Valved Graft. Long-term outcomes following Medtronic Open Pivot valved conduit Prosthetic Heart Valves - Medscape New York: Springer Verlag; 1998:53-71. 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. 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. Accessed April 20, 2021. Contraindications: None known . Eur J Cardiothorac Surg. 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. MRI Resources | Medtronic Emery RW, Petersen RJ, Kersten TE, et al. 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 Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Update my browser now. The initial United States experience with the ATS mechanical cardiac valve prosthesis. In: Krian A, Matloff JM, Nicoloff DM, eds. 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. Object Info: - MRI Safety 2001;4(4):346-352. Cardiovascular More than 140,000 valves have been implanted worldwide. Click Continue to close this window and view the sites content. Technical Support. Please review applicable product labeling for your country for indications and instructions prior to use. 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. Limitations of Liability. On-X Aortic Heart Valve Hemodynamics - CryoLife, Inc. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Healthcare Professionals Cardiovascular Cell Mater. 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. November 1999;22(11):754-763. Fifteen years of experience with ATS mechanical heart valve - PubMed Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Medtronic Open Pivot Aortic Valved Graft (AVG) LifeLine CardioVascular J Thorac Cardiovasc Surg. Indications, Safety, and Warnings. March 2004;13(2):231-238. Heart Valves Surgical The initial United States experience with the ATS mechanical cardiac valve prosthesis. Emery RW, Petersen RJ, Kersten TE, et al. Early results. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. Cardiovascular Is the St. Jude Heart Valve MRI Safe? - Reference.com 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 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. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 2000;69:507-512. Medtronic Open Pivot | Manualzz Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Safety Topic/Article: Open Pivot Mechanical Heart Valve - Medtronic 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. Products 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 3: Conditional 5 More. on x prosthetic heart valve ascending aortic proth. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Reporting Issues and Feedback. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Click OK to confirm you are a Healthcare Professional. Warnings/Precautions/Adverse Events Open Pivot Mechanical Heart Valves Healthcare Professionals Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. With an updated browser, you will have a better Medtronic website experience. Heart Valve Replacement - Surgical March 2004;13(2):231-238. Important Labeling Information for United States. Advanced Discussion (show/hide) References MeSH terms Adolescent Adult Aged Aorta / surgery* 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. Avalus Bioprosthesis - Surgical Heart Valves | Medtronic As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Even very old stainless steel valves are likewise considered of no danger in MRI. Indications, Safety, and Warnings - Open Pivot Aortic - Medtronic 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. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. September 1993;106(3):427-433. Mitral bi-leaflet mechanical heart valve prosthesis An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. Sezai A, Hata M, Niino T, et al. The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. 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. 2003;75(2):444-452. Accessed April 20, 2021. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. 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 . Prosthetic heart valves: Evaluation of magnetic field interactions The content may not be approved for use in your specific region or country. Limited License Grant. You just clicked a link to go to another website. Legal Compliance. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Email: Corporate.UDI@medtronic.com CLOSE . 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). Ann Thorac Surg. 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. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts.
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