Long-term outcomes following Medtronic Open Pivot valved conduit 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.
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Eur J Cardiothorac Surg. More R and Haubold A.
March 2004;13(2):231-238.
A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Proven Graft Material Prosthetic Heart Valves - Medscape Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. 2006; 33: 154-159. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. 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
Premarket Approval (PMA). Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
Heart Valves Surgical 2000;69:507-512.
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.
Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: The initial United States experience with the ATS mechanical cardiac valve prosthesis.
Term, Termination, Modifications, and Support. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) November 1999;22(11):754-763. Note: Manuals can be viewed using a current version of any major internet browser. In addition, upon Medtronics request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction. Limitations of Liability. Refer to the Instructions for Use packaged with each aortic valved graft 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. ) P 844-SUTURES (788-8737) P 888.416.2409. 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. Single-plane orifice facilitates valve seating and implant regardless of suture technique. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. The content may not be approved for use in your specific region or country.
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. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 2009;18(4):445-452.
September 1993;106(3):427-433. 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. 1996;2(1):51-58. Eur J Cardiothorac Surg. 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. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Your use of the other site is subject to the terms of use and privacy statement on that site.
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Emery RW, Petersen RJ, Kersten TE, et al. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com J Heart Valve Dis. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Heart Surg Forum.
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.
Van Nooten GJ, Caes F, Francois K, et al.
Safety Topic/Article: MR safety: cardiac valves - Questions and Answers in MRI Advancing the Technology of Bileaflet Mechanical HeartValves.
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A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Ann Thorac Surg. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Technical Support. 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. ) Update my browser now. If you continue, you will leave this site and go to a site run by someone else. Van Nooten GJ, Caes F, Francois K, et al. Heart Valve Replacement - Surgical
AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. 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. Home 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. Emery RW, Petersen RJ, Kersten TE, et al. 2003;75(2):444-452.
It is possible that some of the products on the other site are not approved in your region or country. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. THE List - MRI Safety Home The Suture Superstore that provides surgical disposables, sutures & more.
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. (4) Hassler M, et al. In: Krian A, Matloff JM, Nicoloff DM, eds. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. AccessGUDID - DEVICE: Medtronic Open Pivot (00763000318581) Potential Adverse Events: Certain complications may occur with heart valve procedures.
Premarket Approval (PMA) - Food and Drug Administration Twenty-Year Single-Center Experience With the Medtronic Open Pivot
Heart Valves Surgical Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Krian A.
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. Your Personal Information. You just clicked a link to go to another website. New York: Springer Verlag; 1998:53-71. 1999; 22:754-763. 2000;69:507-512. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) 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.
Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Sezai A, Hata M, Niino T, et al. Product Details Back to top Temporary Myocardial Pacing Leads TEMPORARY PACING LEADS Click Continue to close this window and view the sites content.
With an updated browser, you will have a better Medtronic website experience. 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. Home Home Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Open Pivot Mechanical Heart Valve - Medtronic THE List - MRI Safety Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device.
Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Open Pivot Mechanical Heart Valves.
Healthcare Professionals Heart Surgery Forum.
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. F 708.478.3519. November 1999;22(11):754-763.
A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Note: Manuals can be viewed using a current version of any major internet browser. 2009;18(4):445-452.
2001;4(4):346-352. 2001;4(4):346-352. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 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. 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability.
In: Krian A, Matloff JM, Nicoloff DM, eds. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form.
J Vasc Surg.
ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5:
1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. 1996;10(8):660-665.
PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship Krian A. Ann Thorac Surg. Cardiovascular New York: Springer Verlag; 1998:53-71. Open Pivot Mechanical Heart Valves - Surgical Heart Valves - Medtronic
MeSH terms Adolescent Adult Aged Aorta / surgery*
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. Fifteen years of experience with ATS mechanical heart valve - PubMed Availability. J Radiol 1986;67:661-666. Healthcare Professionals 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. Emery RW, Van Nooten GJ, Tesar PJ.
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
With an updated browser, you will have a better Medtronic website experience. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft Surgical Heart Valve Repair and Replacement THE LICENSED SOFTWARE IS PROVIDED TO YOU AS IS, AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. Clinical results of a large series of ATS valve implants. Update my browser now.
With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Update my browser now. Healthcare Professionals THE List - MRI Safety Home
1996;2(1):51-58.
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. 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. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. LifeLine CardioVascular
THE List - MRI Safety March 2004;13(2):231-238. Five-year follow up of the ATS mechanical heart valve. The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More.
AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com.
2010;139:1494-1500. Int J Artif Organs.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
1996;10(8):660-665. LifeLine CardioVascular
Ann Thorac Surg.
1996;10(8):660-665.
FDA Determined Cause 2: Labeling mix-ups . All information that you provide in connection with such registration must be complete, accurate, and truthful. U.S. Food & Drug Administration.
MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. ATS Medical Demo Mitral Valve | National Museum of American History
Ann Thorac Surg. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves.
Healthcare Professionals 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.
For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals.
2001;4(4):346-352. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Ann Thorac Surg.
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. Tex Heart Inst J. J Heart Valve Dis. Eur J Radiol 1992;2:555-558. Ann Thorac Cardiovasc Surg.
georgia ad valorem tax family member | | absorbed crossword clue 7 letters. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.
Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While 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.7,8. 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Limited License Grant. Advanced Discussion (show/hide) References 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. Krian A. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. Ann Thorac Cardiovasc Surg. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.
Heart Valves Surgical J Thorac Cardiovasc Surg.
The leaflets are made of solid pyrolytic carbon with a thin titanium band.
what happened in 1906 in europe 2004 Mar;13(2):231-238.
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. Open Pivot Mechanical Heart Valve.
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. 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. 3: Conditional 5 More.
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.
J Heart Valve Dis. The reoperation rate was 1.2%. Products
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. When im-planted in the aortic position there were only .
U.S. Food & Drug Administration. Emery RW, Van Nooten GJ, Tesar PJ. Home This site is Exclusively Sponsored by BRACCO.
Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG.
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Shiono M, Sezai Y, Sezai A, et al. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Premarket Approval (PMA).
You just clicked a link to go to another website. Sezai A, Shiono M, Orime Y, et al. Cardiovascular Note: Manuals can be viewed using a current version of any major internet browser. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Note: Manuals can be viewed using a current version of any major internet browser. Please consult the approved indications for use.
Premarket Approval (PMA). 2,3 .
Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Fifteen years single-center experience with the ATS bileaflet valve. 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. Indications, Safety, & Warnings.
Advancing the Technology of Bileaflet Mechanical HeartValves. 2000;69:507-512. 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).