Early results. J Heart Valve Dis. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. 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. ) Update my browser now. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Patients November 1999;22(11):754-763. Indications, Safety, and Warnings - Open Pivot Aortic - Medtronic 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. 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). A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. 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 For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Heart Valves Surgical 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. 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. Shiono M, Sezai Y, Sezai A, et al. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Tex Heart Inst J. Cardiovascular 1996(10):660-665. With an updated browser, you will have a better Medtronic website experience. 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. Ann Thorac Surg. Healthcare Professionals Premarket Approval (PMA). You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. J Radiol 1986;67:661-666. 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. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. Masters Mitral and Aortic Mechanical Valves | Abbott U.S. Food & Drug Administration. Note: Manuals can be viewed using a current version of any major internet browser. F 708.478.3519. 2003;75(2):444-452. 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. MR safety: cardiac valves - Questions and Answers in MRI The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Emery RW, Krogh CC, Jones DJ, et al. 2006; 33: 154-159. Safety Topic/Article: It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Emery RW, Van Nooten GJ, Tesar PJ. 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. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 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. 2001;4(4):346-352. New York: Springer Verlag; 1998:53-71. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Update my browser now. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Important Safety Information. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Ln N Plymouth MN 55447-5439: Manufacturer Reason for Recall: Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU OR YOUR ASSOCIATED HOSPITAL, CLINIC, OR PRACTICE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE, SESSIONS KEYS, OR THESE TERMS OF USE (WHETHER IN WARRANTY, CONTRACT, TORT, OR OTHERWISE, INCLUDING NEGLIGENCE, AND EVEN IF MEDTRONIC HAS BEEN ADVISED OF THE POSSIBILITY THEREOF), INCLUDING WITHOUT LIMITATION MEDICAL EXPENSES, LOSS OF REVENUE OR PROFITS, OR DAMAGES RESULTING FROM LOSS, MISAPPROPRIATION, OR UNAUTHORIZED OR MALICIOUS ACCESS TO OR MODIFICATION OF DEVICE DATA, OR FROM MISTAKES, OMISSIONS, OR DELAYS IN TRANSMISSION OF INFORMATION, OR FROM INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS, VIRUSES OR FAILURES OF PERFORMANCE, OR FROM THE IMPACT OF THE USE ON YOUR SYSTEM. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Even very old stainless steel valves are likewise considered of no danger in MRI. 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. ) 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. This device may be used to replace a previously implanted prosthetic heart valve or conduit. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 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. Your Personal Information. Int J Artif Organs. Note: Manuals can be viewed using a current version of any major internet browser. 1996;2(1):51-58. 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). Open Pivot Mechanical Heart Valves - Surgical Heart Valves - Medtronic Limited License Grant. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Ats Medical Heart Valve Mri Safety | Day of Difference Fifteen years of experience with ATS mechanical heart valve - PubMed If you continue, you will leave this site and go to a site run by someone else. 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 and Annuloplasty Rings More. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Indications, Safety, and Warnings. 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. 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%. Home 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . 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. MeSH terms Adolescent Adult Aged Aorta / surgery* 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Availability. March 2004;13(2):231-238. Medtronic Open Pivot Heart Valve Instructions for Use. November 1999;22(11):754-763. Miscellaneous. Central/Eastern Europe, Middle East & Africa, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement, Supra-annular compact cuff configuration for excellent suturability and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic and mitral 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. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. 2000;69:507-512. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Ann Thorac Surg. Cardiovascular Please review applicable product labeling for your country for indications and instructions prior to use. With an updated browser, you will have a better Medtronic website experience. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. Healthcare Professionals P 844-SUTURES (788-8737) P 888.416.2409. Reporting Issues and Feedback. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. MEDTRONIC ATS MEDICAL . Note: Manuals can be viewed using a current version of any major internet browser. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. On-X Aortic Heart Valve Hemodynamics - CryoLife, Inc. 2001;4(4):346-352. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Home The initial United States experience with the ATS mechanical cardiac valve prosthesis. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Update my browser now. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart Surgery Forum. J Heart Valve Dis. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Products Healthcare Professionals It is possible that some of the products on the other site are not approved in your region or country. 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. 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. Emery RW, Petersen RJ, Kersten TE, et al. J Thorac Cardiovasc Surg. Emery RW, Petersen RJ, Kersten TE, et al. Legal Compliance. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. You shall at all times use the Licensed Software in compliance with all applicable laws. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. 2000;69:507-512. Potential Adverse Events: Certain complications may occur with heart valve procedures. 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 Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. 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. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. With an updated browser, you will have a better Medtronic website experience. March 2004;13(2):231-238. Cardiovascular U.S. Food & Drug Administration. Medtronic Open Pivot | Manualzz The leaflets are made of solid pyrolytic carbon with a thin titanium band. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis.
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