Int J Artif Organs.
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View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve 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. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
Five-year follow up of the ATS mechanical heart valve. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Update my browser now. Disclaimer: This page may include information about products that may not be available in your region or country. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Reporting Issues and Feedback.
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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.
2003;75(2):444-452. 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.
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. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. 2001;4(4):346-352.
Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 2000;69:507-512.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Ann Thorac Surg. J Heart Valve Dis. Note: Manuals can be viewed using a current version of any major internet browser. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. 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.
Warnings/Precautions/Adverse Events With an updated browser, you will have a better Medtronic website experience. 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. 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 Shiono M, Sezai Y, Sezai A, et al. 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.
Your Personal Information.
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. More than 140,000 valves have been implanted worldwide. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Emery RW, Van Nooten GJ, Tesar PJ. THE LICENSED SOFTWARE IS PROVIDED TO YOU AS IS, AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT.
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. Update my browser now. Indications for Use The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, or malfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America. )
Medtronic Open Pivot Heart Valve Instructions for Use. Fifteen years single-center experience with the ATS bileaflet valve. September 1993;106(3):427-433.
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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. Van Nooten GJ, Caes F, Francois K, et al. The Suture Superstore that provides surgical disposables, sutures & more.
Krian A. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. data, and the Medtronic valves are no exception. With an updated browser, you will have a better Medtronic website experience.
Early results. This site is Exclusively Sponsored by BRACCO. If not approved, please exit this site. Washington D.C.: U.S. Food and Drug Administration; 2000.
Heart Valves Surgical Miscellaneous. Ann Thorac Surg.
Your use of the other site is subject to the terms of use and privacy statement on that site. Effects of magnetic fields used in MRI on 15 prosthetic heart valves.
Heart Surg Forum. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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.
Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV.
Note: Manuals can be viewed using a current version of any major internet browser. Limitations of Liability. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password.
Heart Valve Replacement - Surgical Emery RW, Petersen RJ, Kersten TE, et al.
2000;69:507-512. Products
Single-plane orifice facilitates valve seating and implant regardless of suture technique.
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.
Open Pivot Aortic Valved Graft Certain complications may occur with heart valve procedures. Note: Manuals can be viewed using a current version of any major internet browser. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.
MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy.
A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 2001; 4(4):346-353.
Products
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 The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics.
Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.
1996;6: 273-79.
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. 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.
Krian A.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. All information that you provide in connection with such registration must be complete, accurate, and truthful. 3: . Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories
The initial United States experience with the ATS mechanical cardiac valve prosthesis.
Fifteen years of experience with ATS mechanical heart valve prostheses. Int J Artif Organs. J Heart Valve Dis. 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. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.
Update my browser now.
Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Potential Adverse Events: Certain complications may occur with heart valve procedures.
J Heart Valve Dis. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Sezai A, Hata M, Niino T, et al.
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).
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.
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. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M 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. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com.
2,3 . 1999; 22:754-763. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision.
Important Labeling Information for United States. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. , chronic renal failure, hyperparathyroidism). 2000;69:507-512. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Mechanical Heart Valves, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification.
Sezai A, Shiono M, Orime Y, et al. 2003;75(2):444-452. Open Pivot valves are remarkably quiet.7,10. 2009;18(4):445-452. March 2004;13(2):231-238. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71.
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. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification.
Security/Privacy of Patient Data. March 2004;13(2):231-238. 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.
1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Products
. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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. ) Clinical results of a large series of ATS valve implants. 6-8 Outstanding Durability LifeLine CardioVascular
The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design.
Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Van Nooten GJ, Caes F, Francois K, et al.
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. In: Krian A, Matloff JM, Nicoloff DM, eds. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Update my browser now. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form.
The initial experience with the ATS Medical mechanical cardiac valve prosthesis.
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