These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.
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. Kelly SGD, Verdonck PR, Vierendeels JAM, et al.
MR safety: cardiac valves - Questions and Answers in MRI 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability.
March 2004;13(2):231-238. Indications, Safety, & Warnings. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5:
All information that you provide in connection with such registration must be complete, accurate, and truthful. Medtronic Open Pivot Heart Valves Product Specifications medtronic open pivot Standard Heart valve Aortic Standard Tissue Annulus Orifice Inner Geometric Valve Size Model Diameter (B) Diameter (A) Orifice Area (mm) Number (mm) (mm) (cm2) 19 500FA19 19.5 14.8 1.55 21 500FA21 21.5 16.8 2.02 23 500FA23 23.5 18.8 2.56
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.
LifeLine CardioVascular
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. 1996;6: 273-79.
Safety Topic/Article: U.S. Food & Drug Administration. THE List - MRI Safety A recent publication from a single center in Belgium followed all patients with an Open Pivot valve im-planted over a 20 year period.81 In total, 1520 Open Pivot valves were implanted in 1382 consecutive patients with a 99% rate of follow-up. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin.
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Open Pivot Aortic Valved Graft - Surgical Heart Valves | Medtronic CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000.
Indications, Safety, and Warnings - Medtronic Emery RW, Van Nooten GJ, Tesar PJ. The Suture Superstore that provides surgical disposables, sutures & more. The content may not be approved for use in your specific region or country.
J Thorac Cardiovasc Surg. THE List - MRI Safety Home Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Home Products Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Heart Valves Surgical
Open Pivot Mechanical Heart Valves
.
Open Pivot Mechanical Heart Valves.
Shiono M, Sezai Y, Sezai A, et al. U.S. Food & Drug Administration.
Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. If you continue, you will leave this site and go to a site run by someone else. 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. 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. Object Info: - MRI Safety 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. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Krian A. 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). Limitations of Liability.
2001;4(4):346-352. Home
Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 1996;2(1):51-58. Heart Valves and Annuloplasty Rings More. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. Products Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life.
Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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 .
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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis.
Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. 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.
Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Update my browser now. 1996;10(8):660-665.
More R and Haubold A. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
Unique axis of suspension results in leaflet movement responsive to physiological demands; Gentle, passive washing ensures complete washing of the pivot in both open and closed positions; Most patients cannot hear the sound of their valve after implantation; Low levels of hemolysis and thromboembolic events Cell Mater. 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).
MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. Medtronic Open Pivot Heart Valve Instructions for Use. CarboMedics Prosthetic Heart Valve - an overview - ScienceDirect Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) MEDTRONIC ATS MEDICAL . 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. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. On-X Aortic Heart Valve Hemodynamics - CryoLife, Inc. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
Fifteen years single-center experience with the ATS bileaflet valve. Van Nooten GJ, Caes F, Francois K, et al. Medtronic Open Pivot | Manualzz Open Pivot valves are remarkably quiet.7,10. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. November 1999;22(11):754-763.
Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. Accessed April 20, 2021. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.
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.
Treatments & Therapies
Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Home THE List - MRI Safety Home For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals.
Emery RW, Van Nooten GJ, Tesar PJ. Open Pivot Mechanical Heart Valves. Masters Mitral and Aortic Mechanical Valves | Abbott
You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction.
Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Limited License Grant. Your use of the other site is subject to the terms of use and privacy statement on that site. 1.5, 3: 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.
Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Five-year follow up of the ATS mechanical heart valve. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. Int J Artif Organs. With an updated browser, you will have a better Medtronic website experience.
Please review applicable product labeling for your country for indications and instructions prior to use. If you continue, you may go to a site run by someone else.
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. Home The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form.
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. )
Your Acknowledgements. 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. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. Washington D.C.: U.S. Food and Drug Administration; 2000.
The graft should not be implanted in patients with a known sensitivity to products of bovine origin. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning.
CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Accessed April 20, 2021.
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. Five-year follow up of the ATS mechanical heart valve. Sezai A, Shiono M, Orime Y, et al.
Medtronic, Inc. (Medtronic) offers RemoteView, which permits a user (Programmer User) of the Medtronic CareLink 2090 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 professionals or Medtronic representatives. 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. Note: Manuals can be viewed using a current version of any major internet browser. 3: . Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Emery RW, Petersen RJ, Kersten TE, et al. 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.
By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. 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.