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.
Eur J Cardio-thorac Surg.
Products 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 . Update my browser now. Healthcare Professionals Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Open Pivot Mechanical Heart Valve - Medtronic
1996; 2(1):51-58.
Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.
These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
THE List - MRI Safety Home
Note: Manuals can be viewed using a current version of any major internet browser.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
Sezai A, Shiono M, Orime Y, et al. 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. J Vasc Surg. AccessGUDID - DEVICE: Open Pivot (00613994960412) Int J Artif Organs. Shiono M, Sezai Y, Sezai A, et al. J Heart Valve Dis. 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.
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.
You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software.
Cardiovascular 25 November 2022 0 Comments. 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. 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.
Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.
Eur J Cardiothorac Surg.
Note: Manuals can be viewed using a current version of any major internet browser. Healthcare Professionals The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 3: Conditional 5 More. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis.
2003;75(2):444-452. With an updated browser, you will have a better Medtronic website experience. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. )
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. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Availability. (4) Hassler M, et al. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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. Proven Graft Material You just clicked a link to go to another website.
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).
Eur J Cardiothorac Surg. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password.
Emery RW, Petersen RJ, Kersten TE, et al. Important Safety Information. All information that you provide in connection with such registration must be complete, accurate, and truthful.
Limited License Grant. Indications, Safety, & Warnings.
Premarket Approval (PMA). 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. Heart - Medtronic Vascular - eSutures - The Suture Superstore 2000;69:507-512.
Disclaimer: This page may include information about products that may not be available in your region or country. 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.
For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative.
The reoperation rate was 1.2%.
Fifteen years single-center experience with the ATS bileaflet valve. Heart Valves Surgical
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. 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. 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.
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. With an updated browser, you will have a better Medtronic website experience. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Medtronic Open Pivot Heart Valve Instructions for Use. 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.
AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement.
The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Emery RW, Van Nooten GJ, Tesar PJ. Your use of the other site is subject to the terms of use and privacy statement on that site. Update my browser now. Healthcare Professionals
Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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.
Object Info: - MRI Safety
ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000.
If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. medtronic open pivot - Cor-Medical The initial United States experience with the ATS mechanical cardiac valve prosthesis.
New York: Springer Verlag; 1998:53-71. In: Krian A, Matloff JM, Nicoloff DM, eds. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Fifteen years of experience with ATS mechanical heart valve prostheses. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.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. 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. Note: Manuals can be viewed using a current version of any major internet browser.
2010;139:1494-1500. Open Pivot Aortic Valved Graft
505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm Sezai A, Shiono M, Orime Y, et al. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Technical Support.
Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance.
Reporting Issues and Feedback. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve.
Open Pivot valves are remarkably quiet.7,10.
Heart Valves Surgical
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). Logging of Session Activity. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Please review applicable product labeling for your country for indications and instructions prior to use. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Medtronic Open Pivot Aortic Valved Graft (AVG)
Even very old stainless steel valves are likewise considered of no danger in MRI. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
This Agreement shall be in effect from the date when you first install or use the Licensed Software. Phone Numbers. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. If not approved, please exit this site. Masters Mitral and Aortic Mechanical Valves | Abbott The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
Ann Thorac Surg.
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Ann Thorac Surg.
March 2004;13(2):231-238. Home 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. Int J Artif Organs.
New York: Springer Verlag; 1998:53-71.
Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 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. Healthcare Professionals 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. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Eur J Cardiothorac Surg. March 2004;13(2):231-238. THE List - MRI Safety
Open Pivot Mechanical Heart Valves - Surgical Heart Valves - 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. Note: Manuals can be viewed using a current version of any major internet browser.
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. 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. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft.