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. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 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. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. March 2004;13(2):231-238. J Thorac Cardiovasc Surg. MRI Resources, For clinicians whose patients have a Medtronic system. U.S. Food & Drug Administration. Your use of the other site is subject to the terms of use and privacy statement on that site. Accessed April 20, 2021. 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. Home Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. 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. Tex Heart Inst J. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: 1996;10(8):660-665. Int J Artif Organs. Clinical results of a large series of ATS valve implants. 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. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 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). 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Healthcare Professionals 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. MEDTRONIC ATS MEDICAL . 2009;18(4):445-452. 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. Heart Valves Surgical J Heart Valve Dis. 1996;2(1):51-58. In addition, upon Medtronics request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction. 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). 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. Open Pivot Aortic Valved Graft. 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. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Sezai A, Shiono M, Orime Y, et al. Indications, Safety, and Warnings. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. LifeLine CardioVascular 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). 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. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. 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. Cardiovascular The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. It is possible that some of the products on the other site are not approved in your region or country. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Products Warnings/Precautions/Adverse Events Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Heart Valves and Annuloplasty Rings More. 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. Advanced Discussion (show/hide) References Technical Support. 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. Session Key. When im-planted in the aortic position there were only . J Heart Valve Dis. 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Important Safety Information. In the event that any provision of this Agreement violates any applicable statute, ordinance, or rule of law, such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Update my browser now. 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 Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. (4) Hassler M, et al. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Please consult the approved indications for use. With an updated browser, you will have a better Medtronic website experience. Van Nooten GJ, Caes F, Francois K, et al. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Limited License Grant. 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. Update my browser now. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. J Radiol 1986;67:661-666. 2003;75(2):444-452. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Potential Adverse Events: Certain complications may occur with heart valve procedures. Ann Thorac Surg. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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). Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. November 1999;22(11):754-763. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Note: Manuals can be viewed using a current version of any major internet browser. Advancing the Technology of Bileaflet Mechanical HeartValves. Five-year follow up of the ATS mechanical heart valve. With an updated browser, you will have a better Medtronic website experience. 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. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Heart Valves and Annuloplasty Rings More. Open Pivot Mechanical Heart Valve. Ann Thorac Surg. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Cardiovascular Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Ann Thorac Surg. Heart Valve Replacement - Surgical The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. 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. Fifteen years of experience with ATS mechanical heart valve prostheses. Permissions. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. Premarket Approval (PMA). The content may not be approved for use in your specific region or country. Phone Numbers. Eur J Radiol 1992;2:555-558. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Your Personal Information. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. 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. 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. Update my browser now. Contraindications: None known . With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. More than 140,000 valves have been implanted worldwide. 6-8 Outstanding Durability georgia ad valorem tax family member | | absorbed crossword clue 7 letters. 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. 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. Home Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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 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. Treatments & Therapies It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Clinical results of a large series of ATS valve implants. The Suture Superstore that provides surgical disposables, sutures & more. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Thus at present, most centers consider all implanted heart valves and annuloplasty rings conditionally safe for MR imaging up to 3.0T, and do not require any waiting period after surgery before they can be scanned. Eur J Cardiothorac Surg. 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. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. J Heart Valve Dis. 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. Medtronic open pivot mechanical valves offer exceptional performance: Remarkable thromboresistance: Continuous passive washing provides for gentle treatment of blood cells and low levels of hemolysis and thromboembolic events. Aortic and Mitral Valve Replacement Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Shiono M, Sezai Y, Sezai A, et al. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Emery RW, Petersen RJ, Kersten TE, et al. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 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. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Healthcare Professionals Medtronic Open Pivot Heart Valve Instructions for Use. J Heart Valve Dis. Healthcare Professionals Cardiovascular 25 November 2022 0 Comments. J Thorac Cardiovasc Surg. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Int J Artif Organs. 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. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Update my browser now. Please review applicable product labeling for your country for indications and instructions prior to use. on x prosthetic heart valve ascending aortic proth. Home 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). Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Home With an updated browser, you will have a better Medtronic website experience. Five-year follow up of the ATS mechanical heart valve. Products 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. If you continue, you will leave this site and go to a site run by someone else. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Note: Manuals can be viewed using a current version of any major internet browser. November 1999;22(11):754-763. Emery RW, Petersen RJ, Kersten TE, et al. 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 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. ) Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Premarket Approval (PMA). 1.5, 3: More R and Haubold A. Disclaimer: This page may include information about products that may not be available in your region or country. Limitations of Liability. 2004 Mar;13(2):231-238. Int J Artif Organs. Update my browser now. Surface chemistry and surface roughness of clinical pyrocarbons. Sezai A, Hata M, Niino T, et al. With an updated browser, you will have a better Medtronic website experience. LifeLine CardioVascular MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation.
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