medtronic open pivot heart valve mri safety

The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. 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). On-X Aortic Heart Valve Hemodynamics - CryoLife, Inc. Active Remote Users. When im-planted in the aortic position there were only . 2000;69:507-512. 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. Proven Graft Material Tex Heart Inst J. Eur J Cardiothorac Surg. Fifteen years single-center experience with the ATS bileaflet valve. 2003;75(2):444-452. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Heart Surg Forum. 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. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Int J Artif Organs. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. F 708.478.3519. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Medtronic Open Pivot | Manualzz Heart Valve Replacement - Surgical 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. Premarket Approval (PMA) The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. THE List - MRI Safety Home You shall at all times use the Licensed Software in compliance with all applicable laws. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Update my browser now. J Thorac Cardiovasc Surg. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Note: Manuals can be viewed using a current version of any major internet browser. Update my browser now. J Heart Valve Dis. MeSH terms Adolescent Adult Aged Aorta / surgery* Emery RW, Van Nooten GJ, Tesar PJ. 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. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 2000;69:507-512. Masters Mitral and Aortic Mechanical Valves | Abbott In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. Indications, Safety, & Warnings. Accessed April 20, 2021. 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. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. This Agreement constitutes the entire agreement between Medtronic and you regarding your use of the Licensed Software and supersedes any prior and contemporaneous written or oral agreements or understandings related to the Licensed Software. LifeLine CardioVascular Prosthetic heart valves: Evaluation of magnetic field interactions Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Update my browser now. Email: Corporate.UDI@medtronic.com CLOSE . 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. 3: . Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. More than 140,000 valves have been implanted worldwide. 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 ]. Heart Surg Forum. Surgical Heart Valve Repair and Replacement Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. J Heart Valve Dis. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Premarket Approval (PMA). Ann Thorac Cardiovasc Surg. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. LifeLine CardioVascular For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Technical Support. 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. PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. 2003;75(2):444-452. 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. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Open Pivot Mechanical Heart Valves - Surgical Heart Valves - Medtronic Except as expressly provided herein, no person or entity other than Medtronic and you, including without limitation any patient, is or shall be a third party beneficiary of this Agreement or otherwise entitled to bring any action to enforce any provision of this Agreement against Medtronic or you. Please consult the approved indications for use. 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. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. J Heart Valve Dis. J Radiol 1986;67:661-666. Sezai A, Shiono M, Orime Y, et al. Update my browser now. Five-year follow up of the ATS mechanical heart valve. 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. Home 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. Int J Artif Organs. Indications, Safety, and Warnings. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. 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. All information that you provide in connection with such registration must be complete, accurate, and truthful. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card 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. 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 Suture Superstore that provides surgical disposables, sutures & more. 2009;18(4):445-452. On-X Life Technologies, Inc. P000037 S059: 03/24/2022: 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. With an updated browser, you will have a better Medtronic website experience. November 1999;22(11):754-763. Fifteen years single-center experience with the ATS bileaflet valve. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft Treatments & Therapies 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. November 1999;22(11):754-763. 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. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. 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. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Logging of Session Activity. More R and Haubold A. The initial United States experience with the ATS mechanical cardiac valve prosthesis. THE List - MRI Safety 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. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. 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. 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. data, and the Medtronic valves are no exception. Premarket Approval (PMA) Cardiovascular Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Home Note: Manuals can be viewed using a current version of any major internet browser. Heart Valves Surgical Premarket Approval (PMA) - Food and Drug Administration Open Pivot Mechanical Heart Valve. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Sezai A, Shiono M, Orime Y, et al. Open Pivot Mechanical Heart Valve - Medtronic The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Heart Valve Design & Features - CryoLife, Inc. J Heart Valve Dis. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Phone Numbers. Krian A. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Five-year follow up of the ATS mechanical heart valve. Surface chemistry and surface roughness of clinical pyrocarbons. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Ann Thorac Surg. 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%. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Emery RW, Van Nooten GJ, Tesar PJ. Safety Topic/Article: 1.5, 3: 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. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve With an updated browser, you will have a better Medtronic website experience. Session Key. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. MR safety: cardiac valves - Questions and Answers in MRI Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Krian A. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Indications, Safety, and Warnings - Open Pivot Mechanical Heart Valves Brand Name: Medtronic Open Pivot Version or Model: 569 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC 3F THERAPEUTICS, INC. Primary DI Number: 00763000318581 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527232 * Terms of Use Early results. Home For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. Update my browser now. 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. If you continue, you will leave this site and go to a site run by someone else. With an updated browser, you will have a better Medtronic website experience. 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.