Indications, Safety, and Warnings - Open Pivot Aortic - Medtronic
Update my browser now. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. 1996;10(8):660-665.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.
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. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. )
Open Pivot Mechanical Heart Valve - Medtronic The user name and password are personal to you and must not be shared with anyone else. New York: Springer Verlag; 1998:53-71. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS
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.
Heart Valve Replacement - Surgical
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. Healthcare Professionals Logging of Session Activity.
on x prosthetic heart valve ascending aortic proth.
505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm The Suture Superstore that provides surgical disposables, sutures & more.
2000;69:507-512.
Technical Support.
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.
Int J Artif Organs.
Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. 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.
Ann Thorac Surg. 1996(10):660-665.
The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement.
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Safety Topic/Article:
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. ) Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. 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. 2009;18(4):445-452. Shiono M, Sezai Y, Sezai A, et al. Potential Adverse Events: Certain complications may occur with heart valve procedures. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft.
Prosthetic heart valves: Evaluation of magnetic field interactions For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. Int J Artif Organs.
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). Early results.
Heart Valve Design & Features - CryoLife, Inc. 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
The adverse events potentially associated with the use ofprosthetic aortic 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. 2004 Mar;13(2):231-238. 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. 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 If you continue, you will leave this site and go to a site run by someone else. The initial United States experience with the ATS mechanical cardiac valve prosthesis. J Heart Valve Dis. 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. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. 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. Home
2000;69:507-512. J Heart Valve Dis. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic.
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. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic
Please review applicable product labeling for your country for indications and instructions prior to use.
Indications, Safety, and Warnings. Update my browser now.
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. (4) Hassler M, et al.
Object Info: - MRI Safety Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. 1996;10(8):660-665. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. New York: Springer Verlag; 1998:53-71. , chronic renal failure, hyperparathyroidism).
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. 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). Note: Manuals can be viewed using a current version of any major internet browser.
Products Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS 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. ) Sezai A, Shiono M, Orime Y, et al.
Home You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies.
2009;18(4):445-452.
Premarket Approval (PMA).
In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet.
J Radiol 1986;67:661-666.
Fifteen years single-center experience with the ATS bileaflet valve.
Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, 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. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 1996;10(8):660-665.
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Home 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. 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. 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. 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. Shiono M, Sezai Y, Sezai A, et al.
Emery RW, Petersen RJ, Kersten TE, et al. Emery RW, Petersen RJ, Kersten TE, et al. Eur J Cardiothorac Surg. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Note: Manuals can be viewed using a current version of any major internet browser.
Premarket Approval (PMA). Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Heart Valves Surgical The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. With an updated browser, you will have a better Medtronic website experience. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Krian A. Accessed April 20, 2021. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design.
PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship 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. Clinical results of a large series of ATS valve implants.
Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com.
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 heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The valve itself was correctly labeled as Mitral.
Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Int J Artif Organs. 2003;75(2):444-452. Potential Adverse Events: Certain complications may occur with heart valve procedures.
Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Ann Thorac Surg.
medtronic open pivot - Cor-Medical 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. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS
Premarket Approval (PMA)
Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.
Update my browser now. Ann Thorac Surg.
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life.
MeSH terms Adolescent Adult Aged Aorta / surgery* 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Shiono M, Sezai Y, Sezai A, et al.
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. Krian A.
Safety Topic / Subject Article Text 179: . For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals.
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
Heart Valves - Surgical | Medtronic Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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. 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.
Proven Graft Material The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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.
Eur J Cardiothorac Surg. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Miscellaneous.
Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG.
View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Cardiovascular Open Pivot valves are remarkably quiet.7,10. what happened in 1906 in europe
MRI Resources | Medtronic You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name.
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.
The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 2,3 .
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).
FDA Determined Cause 2: Labeling mix-ups .
However, further studies are required to determine the effect of valve gradient on survival. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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.
Clinical results of a large series of ATS valve implants.
AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) Open Pivot Aortic Valved Graft.
Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. 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. Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) 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 Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Brand Name: Open Pivot Version or Model: 500FA23 Commercial Distribution Status: Not in Commercial Distribution Catalog Number: Company Name: MEDTRONIC, INC. Primary DI Number: 00613994960412 Issuing Agency: GS1 Commercial Distribution End Date: October 21, 2019 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. 1999; 22:754-763. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Five-year follow up of the ATS mechanical heart valve.
Active Remote Users. Phone Numbers. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics.
1A [10L(02)] Printspec k - 5.25 x 9.875 inches. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. If you continue, you may go to a site run by someone else.
Certain complications may occur with heart valve procedures. Krian A.
THE List - MRI Safety Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin.
Prosthetic Heart Valves - Medscape Fifteen years of experience with ATS mechanical heart valve prostheses. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992.
A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. With an updated browser, you will have a better Medtronic website experience. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com.