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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. J Vasc Surg. Active Remote Users. Eur J Radiol 1992;2:555-558.
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%.
Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 2,9,10
ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Advancing the Technology of Bileaflet Mechanical HeartValves. Ann Thorac Surg. It is possible that some of the products on the other site are not approved in your region or country.
Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
The content may not be approved for use in your specific region or country. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. 2003;75(2):444-452.
Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer.
1999; 22:754-763.
Sezai A, Shiono M, Orime Y, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan.
Premarket Approval (PMA). Heart Valves Surgical Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.
Van Nooten GJ, Caes F, Francois K, et al.
You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
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. Home 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis.
Emery RW, Petersen RJ, Kersten TE, et al. November 1999;22(11):754-763. Heart Surg Forum. 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. Note: Manuals can be viewed using a current version of any major internet browser. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism.
In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Note: Manuals can be viewed using a current version of any major internet browser.
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. 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.
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 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.
Van Nooten GJ, Caes F, Francois K, et al.
Cardiovascular Your use of the other site is subject to the terms of use and privacy statement on that site.
Indications, Safety, & Warnings. Accessed April 20, 2021. 2009;18(4):445-452.
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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.
You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software.
Heart Valves and Annuloplasty Rings More.
Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.
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. 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
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. J Heart Valve Dis. Click OK to confirm you are a Healthcare Professional. Heart Surg Forum. Eur J Cardiothorac Surg. Update my browser now.
If you continue, you will leave this site and go to a site run by someone else. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. In: Krian A, Matloff JM, Nicoloff DM, eds. Indications, Safety, and Warnings. Home 1996; 2(1):51-58. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. Fifteen years of experience with ATS mechanical heart valve prostheses. Indications, Safety, & Warnings.
With an updated browser, you will have a better Medtronic website experience.
For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. P 844-SUTURES (788-8737) P 888.416.2409.
Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG.
Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design.
MRI Resources, For clinicians whose patients have a Medtronic system. Technical Support.
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). Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 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). Important Labeling Information for United States. Update my browser now.
Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Home
Warnings/Precautions/Adverse Events Ann Thorac Surg.
Cell Mater. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. )
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.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative.
Products 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 . Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Products
Kelly SGD, Verdonck PR, Vierendeels JAM, et al. The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. The reoperation rate was 1.2%. More R and Haubold A. Update my browser now.
Cardiovascular The valve itself was correctly labeled as Mitral. Ann Thorac Surg.
With an updated browser, you will have a better Medtronic website experience. Sezai A, Shiono M, Orime Y, et al.
It is possible that some of the products on the other site are not approved in your country. Potential Adverse Events: Certain complications may occur with heart valve procedures. Medtronic Open Pivot Heart Valve Instructions for Use.
2003;75(2):444-452. Heart Valves Surgical
Heart Valves Surgical 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.
Heart Valves and Annuloplasty Rings More. 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.
1996;6: 273-79.
MEDTRONIC ATS MEDICAL .
IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU FOR INTERCEPTION OR COMPROMISE OF ANY INFORMATION OR FOR ANY RECORD OR OTHER COMMUNICATION PROVIDED IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE. Eur J Cardiothorac Surg. Patients Five-year follow up of the ATS mechanical heart valve. Washington D.C.: U.S. Food and Drug Administration; 2000.
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. ) 1996;10(8):660-665.
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.
Note: Manuals can be viewed using a current version of any major internet browser.
Eur J Cardiothorac Surg.
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. All information that you provide in connection with such registration must be complete, accurate, and truthful. Early results. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. Limited License Grant. Your Personal Information. The user name and password are personal to you and must not be shared with anyone else. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Ann Thorac Cardiovasc Surg. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions.
Healthcare Professionals Reproduced with permission from Medtronic, Inc. View Media Gallery Replacement of diseased valves with prosthetic heart valves reduces the morbidity and mortality associated with native. LifeLine CardioVascular
F 708.478.3519.
A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Emery RW, Petersen RJ, Kersten TE, et al. 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. 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). CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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.
Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN .
Five-year follow up of the ATS mechanical heart valve. 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. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Advanced Discussion (show/hide) References Security/Privacy of Patient Data.
The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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. Accessed April 20, 2021. Open Pivot Mechanical Heart Valves. J Heart Valve Dis. 2006; 33: 154-159. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 2,3 . Note: Manuals can be viewed using a current version of any major internet browser. Healthcare Professionals
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.
Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. MeSH terms Adolescent Adult Aged Aorta / surgery*
March 2004;13(2):231-238. 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.
The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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. Heart Valves Surgical