Heart Valves Surgical For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Heart Surg Forum. 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. With an updated browser, you will have a better Medtronic website experience. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Heart Surgery Forum. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Even very old stainless steel valves are likewise considered of no danger in MRI. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Open Pivot Mechanical Heart Valves Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Healthcare Professionals Low target-INR anticoagulation is safe in selected aortic valve patients with the Medtronic Open Pivot mechanical prosthesis: Long-term results of a propensity-matched comparison with standard. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Shiono M, Sezai Y, Sezai A, et al. Home Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Premarket Approval (PMA). Krian A. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Sezai A, Hata M, Niino T, et al. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Sezai A, Shiono M, Orime Y, et al. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. November 1999;22(11):754-763. LifeLine CardioVascular 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: [email protected]. 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). Cardiovascular 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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. March 2004;13(2):231-238. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Cardiovascular With an updated browser, you will have a better Medtronic website experience. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. FDA Determined Cause 2: Labeling mix-ups . The initial United States experience with the ATS mechanical cardiac valve prosthesis. Important Safety Information. 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. Term, Termination, Modifications, and Support. 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. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Open Pivot Aortic Valved Graft. 6-8 Outstanding Durability AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Permissions. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Fifteen years of experience with ATS mechanical heart valve prostheses. When im-planted in the aortic position there were only . 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. Heart Valves 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%. MEDTRONIC ATS MEDICAL, INC. P990046 S065: 10/21/2022: open pivot heart valve, open pivot aortic valved g. MEDTRONIC ATS MEDICAL, INC. P990046 S064: 03/10/2022: 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. 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). 1996;10(8):660-665. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. With regard to any purported agreement or terms of use between you and Bomgar Corporation in connection with the Licensed Software (Bomgar EULA): (a) any Bomgar EULA shall be solely between you and Bomgar Corporation; (b) Medtronic shall not be a party to any Bomgar EULA; (c) any Bomgar EULA shall not necessarily reflect the contents of any agreement between Bomgar Corporation and Medtronic; (d) any Bomgar EULA shall not modify or take precedence over this Agreement; and (e) nothing in this Agreement shall be construed to suggest the enforceability or unenforceability of any Bomgar EULA. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. 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. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. However, further studies are required to determine the effect of valve gradient on survival. 2001;4(4):346-352. Contraindications: None known . Shiono M, Sezai Y, Sezai A, et al. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. Logging of Session Activity. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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. 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. 2009;18(4):445-452. 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 Sezai A, Shiono M, Orime Y, et al. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. 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. Van Nooten GJ, Caes F, Francois K, et al. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Clinical results of a large series of ATS valve implants. Early results. 2009;18(4):445-452. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com 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. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients. Emery RW, Van Nooten GJ, Tesar PJ. Healthcare Professionals Products Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Open Pivot valves are remarkably quiet.7,10. Advancing the Technology of Bileaflet Mechanical HeartValves. on x prosthetic heart valve ascending aortic proth. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. November 1999;22(11):754-763. 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. If you continue, you will leave this site and go to a site run by someone else. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Legal Compliance. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 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. Home Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. March 2004;13(2):231-238. 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. You just clicked a link to go to another website. You shall at all times use the Licensed Software in compliance with all applicable laws. 2000;69:507-512. September 1993;106(3):427-433. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. 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 . J Radiol 1986;67:661-666. Please consult the approved indications for use. Premarket Approval (PMA). The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. 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 Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Update my browser now. Products Heart Valves Surgical Medtronic Open Pivot Aortic Valved Graft (AVG) for Aortic Valve and Ascending Aorta Replacement The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Open Pivot Aortic Valved Graft 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. 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. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Heart Valves Surgical A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. data, and the Medtronic valves are no exception. With an updated browser, you will have a better Medtronic website experience. MeSH terms Adolescent Adult Aged Aorta / surgery* 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. ) Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 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. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Emery RW, Petersen RJ, Kersten TE, et al. 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). Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com.
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