Home Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. . Logging of Session Activity. Technical Support. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Update my browser now. 2003;75(2):444-452. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. More R and Haubold A. 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. Home Update my browser now. In: Krian A, Matloff JM, Nicoloff DM, eds. 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Safety Topic / Subject Article Text 179: . Active Remote Users. Medtronic Open Pivot Heart Valve Instructions for Use. 2006; 33: 154-159. on x prosthetic heart valve ascending aortic proth. 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. 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. 2009;18(4):445-452. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Ann Thorac Cardiovasc Surg. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Legal Compliance. 1996;10(8):660-665. J Heart Valve Dis. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Cardiovascular 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. With an updated browser, you will have a better Medtronic website experience. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Krian A. LifeLine CardioVascular If you continue, you may go to a site run by someone else. Phone Numbers. Miscellaneous. Eur J Cardio-thorac Surg. 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. J Radiol 1986;67:661-666. Healthcare Professionals Home Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart Valves Surgical Tex Heart Inst J. 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. Certain complications may occur with heart valve procedures. 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. 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. 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 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. ) 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. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Fifteen years of experience with ATS mechanical heart valve prostheses. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Eur J Cardiothorac Surg. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. ) MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. (4) Hassler M, et al. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Cardiovascular J Heart Valve Dis. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 1996; 2(1):51-58. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Potential Adverse Events: Certain complications may occur with heart valve procedures. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. Products Medtronic Open Pivot Aortic Valved Graft (AVG) for Aortic Valve and Ascending Aorta Replacement The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 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. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. J Thorac Cardiovasc Surg. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Mechanical Heart Valves, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. 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. J Heart Valve Dis. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Clinical results of a large series of ATS valve implants. Warnings/Precautions/Adverse Events Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Van Nooten GJ, Caes F, Francois K, et al. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. When im-planted in the aortic position there were only . Krian A. Emery RW, Krogh CC, Jones DJ, et al. Home 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). These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. data, and the Medtronic valves are no exception. The initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. New York: Springer Verlag; 1998:53-71. However, further studies are required to determine the effect of valve gradient on survival. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Emery RW, Van Nooten GJ, Tesar PJ. 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. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. You just clicked a link to go to another website. Fifteen years single-center experience with the ATS bileaflet valve. More than 140,000 valves have been implanted worldwide. Effects of magnetic fields used in MRI on 15 prosthetic heart valves. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Potential Adverse Events: Certain complications may occur with heart valve procedures. Healthcare Professionals 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. Int J Artif Organs. Products Limitations of Liability. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a terrorist supporting country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. 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. Heart Valves Surgical NayaMed International Srl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Srl. With an updated browser, you will have a better Medtronic website experience. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Please consult the approved indications for use. Home 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). Emery RW, Petersen RJ, Kersten TE, et al. The content may not be approved for use in your specific region or country. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Healthcare Professionals 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. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Home Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Even very old stainless steel valves are likewise considered of no danger in MRI. Van Nooten GJ, Caes F, Francois K, et al. 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. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 25 November 2022 0 Comments. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Healthcare Professionals Advanced Discussion (show/hide) References These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Update my browser now. Important Safety Information. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Emery RW, Petersen RJ, Kersten TE, et al. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Products Van Nooten GJ, Caes F, Francois K, et al. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. J Heart Valve Dis. With an updated browser, you will have a better Medtronic website experience. Aortic and Mitral Valve Replacement 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 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. 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. Open Pivot valves are remarkably quiet.7,10. Click Continue to close this window and view the sites content. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. With an updated browser, you will have a better Medtronic website experience. Heart Surg Forum. 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. Indications, Safety, & Warnings. Note: Manuals can be viewed using a current version of any major internet browser. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. The Suture Superstore that provides surgical disposables, sutures & more. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. November 1999;22(11):754-763. Ann Thorac Surg. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Email: Corporate.UDI@medtronic.com CLOSE . Open Pivot valves are remarkably quiet.7,10. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: The valve itself was correctly labeled as Mitral. Healthcare Professionals For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Open Pivot Aortic Valved Graft. March 2004;13(2):231-238. Note: Manuals can be viewed using a current version of any major internet browser. Sezai A, Hata M, Niino T, et al. Eur J Radiol 1992;2:555-558. 1996;2(1):51-58. Krian A. Accessed April 20, 2021. P 844-SUTURES (788-8737) P 888.416.2409. You just clicked a link to go to another website. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS MEDTRONIC ATS MEDICAL . 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. As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. J Heart Valve Dis. Five-year follow up of the ATS mechanical heart valve. You shall at all times use the Licensed Software in compliance with all applicable laws. Heart Surg Forum. Availability. Note: Manuals can be viewed using a current version of any major internet browser. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. If you continue, you will leave this site and go to a site run by someone else. 6-8 Outstanding Durability 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. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Home 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). Heart Valves Surgical Note: Manuals can be viewed using a current version of any major internet browser. With an updated browser, you will have a better Medtronic website experience. Ann Thorac Surg. Shiono M, Sezai Y, Sezai A, et al. Open Pivot Aortic Valved Graft Indications, Safety, & Warnings.