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. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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.
Five-year follow up of the ATS mechanical heart valve. By installing or using the Licensed Software to view the Programmer screen information, registering a username and password in connection with the Medtronic RemoteView feature, or clicking on any acceptance button in connection herewith, you, a Remote Viewer, agree to be bound by all of the terms and conditions set forth in these Terms of Use (this Agreement).
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 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. Cardiovascular ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Int J Artif Organs. Medtronic may modify, disable, or terminate your use or Medtronics support of the Licensed Software at any time, including by providing notices on a Medtronic website. Premarket Approval (PMA) - Food and Drug Administration Treatments & Therapies Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Single-plane orifice facilitates valve seating and implant regardless of suture technique.
All information that you provide in connection with such registration must be complete, accurate, and truthful. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart - Medtronic Vascular - eSutures - The Suture Superstore New York: Springer Verlag; 1998:53-71. Cardiovascular Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. With an updated browser, you will have a better Medtronic website experience.
Heart Surgery Forum.
MeSH terms Adolescent Adult Aged Aorta / surgery* Heart Valve Design & Features - CryoLife, Inc.
MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022
With an updated browser, you will have a better Medtronic website experience. 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.
This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS J Heart Valve Dis. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com
November 1999;22(11):754-763. Your Personal Information.
In: Krian A, Matloff JM, Nicoloff DM, eds. Open Pivot valves are remarkably quiet.7,10. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 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.
Int J Artif Organs. J Heart Valve Dis. Open Pivot Mechanical Heart Valves The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. J Thorac Cardiovasc Surg. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. The initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. Reporting Issues and Feedback.
Eur J Cardio-thorac Surg. 1999; 22:754-763. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for Aortic Valve and Ascending Aorta Replacement, 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. Fifteen years of experience with ATS mechanical heart valve prostheses. Medtronic Open Pivot Aortic Valved Graft (AVG)
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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 Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com.
For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals.
Indications, Safety, and Warnings - Open Pivot Mechanical Heart Valves
You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. You just clicked a link to go to another website. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, infection other than endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.
New York: Springer Verlag; 1998:53-71. Advanced Discussion (show/hide) References Note: Manuals can be viewed using a current version of any major internet browser. , chronic renal failure, hyperparathyroidism).
It is possible that some of the products on the other site are not approved in your region or country.
AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581)
Accessed April 20, 2021.
LifeLine CardioVascular
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. Premarket Approval (PMA). 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). Open Pivot Aortic Valved Graft. Update my browser now. Ann Thorac Cardiovasc Surg. Heart Valve Replacement - Surgical 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. 2006; 33: 154-159. Van Nooten GJ, Caes F, Francois K, et al. 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.
Sezai A, Shiono M, Orime Y, et al.
The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Medtronic Open Pivot | Manualzz Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Indications, Safety, & Warnings. 2009;18(4):445-452.
on x prosthetic heart valve ascending aortic proth. 2000;69:507-512. Indications, Safety, & Warnings.
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. You just clicked a link to go to another website.
You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. 1996;6: 273-79.
Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. The content may not be approved for use in your specific region or country. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, 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. Fifteen years single-center experience with the ATS bileaflet valve. Shiono M, Sezai Y, Sezai A, et al. Heart Valves - Surgical | Medtronic
Open Pivot Aortic Valved Graft Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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). Brand Name: Medtronic Open Pivot Version or Model: 569 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC 3F THERAPEUTICS, INC. Primary DI Number: 00763000318581 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527232 * Terms of Use It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Van Nooten GJ, Caes F, Francois K, et al. 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. With an updated browser, you will have a better Medtronic website experience. 2003;75(2):444-452. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Emery RW, Van Nooten GJ, Tesar PJ.
Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Update my browser now. 2,9,10 3: . Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. If you continue, you will leave this site and go to a site run by someone else. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. 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. 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.
AccessGUDID - DEVICE: Open Pivot (00643169078109)
Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 2009;18(4):445-452. This Agreement shall be in effect from the date when you first install or use the Licensed Software. 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.
Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Please review applicable product labeling for your country for indications and instructions prior to use.
Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. More than 140,000 valves have been implanted worldwide. J Radiol 1986;67:661-666. Home Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. March 2004;13(2):231-238. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. In: Krian A, Matloff JM, Nicoloff DM, eds.
J Heart Valve Dis. Note: Manuals can be viewed using a current version of any major internet browser. Open Pivot Mechanical Heart Valves - Surgical Heart Valves | Medtronic
View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose.
Active Remote Users.
Sezai A, Shiono M, Orime Y, et al. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. Permissions. Emery RW, Van Nooten GJ, Tesar PJ. The valve itself was correctly labeled as Mitral. 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.
3: Conditional 5 More. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Products Ann Thorac Surg.
You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. 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. ) 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.
Object Info: - MRI Safety Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis.