medtronic open pivot heart valve mri safety medtronic open pivot heart valve mri safety

LifeLine CardioVascular To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Update my browser now. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. what happened in 1906 in europe J Heart Valve Dis. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Shiono M, Sezai Y, Sezai A, et al. J Heart Valve Dis. Heart Valves Surgical Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 25 November 2022 0 Comments. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. Is the St. Jude Heart Valve MRI Safe? - Reference.com Open Pivot Mechanical Heart Valves - Surgical Heart Valves | Medtronic The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Healthcare Professionals For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Clinical results of a large series of ATS valve implants. Note: Manuals can be viewed using a current version of any major internet browser. Cardiovascular Your Acknowledgements. Home The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Medtronic, Inc. (Medtronic) offers RemoteView, which permits a user (Programmer User) of the Medtronic CareLink 2090 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 professionals or Medtronic representatives. . All information that you provide in connection with such registration must be complete, accurate, and truthful. Fifteen years single-center experience with the ATS bileaflet valve. Note: Manuals can be viewed using a current version of any major internet browser. Indications, Safety, and Warnings - Medtronic 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. THE List - MRI Safety FDA Determined Cause 2: Labeling mix-ups . Five-year follow up of the ATS mechanical heart valve. Advanced Discussion (show/hide) References This site is Exclusively Sponsored by BRACCO. With an updated browser, you will have a better Medtronic website experience. Emery RW, Van Nooten GJ, Tesar PJ. Treatments & Therapies Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Healthcare Professionals 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). Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 2003;75(2):444-452. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Ann Thorac Cardiovasc Surg. With an updated browser, you will have a better Medtronic website experience. 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 The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. September 1993;106(3):427-433. 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. 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. Contraindications: None known . A recent publication from a single center in Belgium followed all patients with an Open Pivot valve im-planted over a 20 year period.81 In total, 1520 Open Pivot valves were implanted in 1382 consecutive patients with a 99% rate of follow-up. Medtronic Open Pivot Heart Valve Instructions for Use. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. Twenty-Year Single-Center Experience With the Medtronic Open Pivot Heart Valves Surgical Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 2004 Mar;13(2):231-238. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. 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. Van Nooten GJ, Caes F, Francois K, et al. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. March 2004;13(2):231-238. 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. 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. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. With an updated browser, you will have a better Medtronic website experience. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Eur J Cardiothorac Surg. Premarket Approval (PMA). Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Clinical results of a large series of ATS valve implants. Heart Surgery Forum. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. 505DA24: Medtronic Open Pivot AP360 Aortic Heart Valve, 24mm P 844-SUTURES (788-8737) P 888.416.2409. 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. medtronic open pivot - Cor-Medical Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Sezai A, Shiono M, Orime Y, et al. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. 2010;139:1494-1500. Patients For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. November 1999;22(11):754-763. 1.5, 3: MRI Resources | Medtronic Heart Valves and Annuloplasty Rings More. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Update my browser now. Krian A. More R and Haubold A. 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. Ann Thorac Surg. Healthcare Professionals Cardiovascular Healthcare Professionals Limitations of Liability. Update my browser now. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Indications, Safety, and Warnings - Open Pivot Aortic - Medtronic 2001;4(4):346-352. 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). J Heart Valve Dis. MEDTRONIC ATS MEDICAL . Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Note: Manuals can be viewed using a current version of any major internet browser. 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. 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. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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. 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. J Thorac Cardiovasc Surg. 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. 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. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Premarket Approval (PMA) Washington D.C.: U.S. Food and Drug Administration; 2000. Sezai A, Shiono M, Orime Y, et al. 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 Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Open Pivot Mechanical Heart Valves The leaflets are made of solid pyrolytic carbon with a thin titanium band. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Phone Numbers. 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. AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) Advancing the Technology of Bileaflet Mechanical HeartValves. 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. 1999; 22:754-763. Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. 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. Technical Support. It is possible that some of the products on the other site are not approved in your country. 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. 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. Contraindications The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Tex Heart Inst J. You just clicked a link to go to another website. 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. 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. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Heart Valve Replacement - Surgical Safety Topic / Subject Article Text 179: . Healthcare Professionals THE List - MRI Safety Home Update my browser now. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 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. 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 will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. Emery RW, Van Nooten GJ, Tesar PJ. THE List - MRI Safety 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. ) U.S. Food & Drug Administration. 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. Emery RW, Petersen RJ, Kersten TE, et al. Potential Adverse Events: Certain complications may occur with heart valve procedures. 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. Home Indications, Safety, and Warnings. Indications, Safety, and Warnings - Open Pivot Mechanical Heart Valves Proven Graft Material More than 140,000 valves have been implanted worldwide. 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. J Heart Valve Dis. Even very old stainless steel valves are likewise considered of no danger in MRI. Session Key. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. 2001;4(4):346-352. Home Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Masters Mitral and Aortic Mechanical Valves | Abbott Important Labeling Information for United States. Object Info: - MRI Safety U.S. Food & Drug Administration. Ann Thorac Cardiovasc Surg. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement, Medtronic Open Pivot Aortic Valved Graft, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification.