Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic MRI safety Heart valve products US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. Healthcare Professionals On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. It is recommended that EpiDisc and MeroGel QuickGel Otologic Dressing be used immediately after the opening of the pouch; discard any unused portion of the device. The following postoperative precautionary measures are recommended: Hydroxylapatite is the basic inorganic constituent of living bone tissue. 1220016001 Rev. Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. Update my browser now. The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. Medtronic Mosaic Porcine Aortic Bioprosthesis | Therapeutic Goods The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. Chole RA and Brummet RE, et al. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. Overview The Mosaic bioprosthesis based on more than 30 years of Medtronic tissue-valve design expertise is a great option for surgeons seeking exceptional long-term durability, excellent hemodynamics, and a smooth implanting experience. Less information (see less). This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T. For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Published clinical experience demonstrates impressive long-term performance in all age groups. MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Bioprostheses for Heart Valve Replacement - Medtronic With an updated browser, you will have a better Medtronic website experience. Contegra is an integrated valved conduit for reconstruction or replacement of the natural right ventricular outflow tract (RVOT) or replacement of a failed homograft or composite pulmonary conduit. 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. Medtronic MRI Resource Library: Home Older mechanical valves (such as Bj, rk-Shiley or caged-ball models,including some made ofstainless steel) may rarely be encountered, but like their modern counterparts are considered, Most common surgically implanted annuloplasty devices haveno metallic components and are, at all field strengths. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. Mosaic & Mosaic Ultra Bioprostheses Home The Mosaicbioprosthesis (MB) (Medtronic, Inc.; Minneapolis, Minn) is a 3rd-generation porcine valve that became clinically available in 1994. Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctable injury to the middle ear from trauma, The presence of middle ear infection which could result in displacement of the implant(s), Conductive hearingloss which may be restored by non-invasive methods. Sapien* device deployed inside Mosaic mitral. Contraindications: None known . Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. 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. With an updated browser, you will have a better Medtronic website experience. Update my browser now. Warning: Persons allergic to cobalt-chromium . AccessGUDID - DEVICE: MOSAIC ULTRA (00885074253244) Indications, Safety, & Warnings. Specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, can result in the alteration of normal leaflet movement as blood flowing through the native annulus might not properly match the size and/or shape of the inflow of the Mosaic Porcine Aortic Bioprosthesis Model 305. Note: Manuals can be viewed using a current version of any major internet browser. Your report will contribute to the TGA's monitoring of these products. It is recommended that EpiDisc be used immediately after the opening of the pouch; discard any unused portion of the device. Am J Oto. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Heart Valves Surgical Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. , chronic renal failure, hyperparathyroidism). Home Warnings / Precautions / Adverse Events PDF Guidelines for Managing Patients with Heart Valve Prostheses - ISMRM Carpentier-Edwards annuloplasty rings, Models 4400 and 4500, marketed from 1980 to 1983, were made of stainless steel. Healthcare Professionals Mosaic and Mosaic Ultra Bioprostheses - Surgical Heart Valves - Medtronic The Avalus bioprosthesis is a pericardial aortic surgical valve designed for better overall performance, improved implant experience, and a contemporary design to facilitate future valve-in-valve (ViV). The CG Future is an annuloplasty system for mitral valve repair, designed to predictably remodel the annulus to maintain apposition of the anterior and posterior leaflets. Can some patients with cardiac pacemakers undergo MRI. Advanced Discussion (show/hide) References CSF Flow Control Valve, Fixed Pressure Medtronic, Inc., www.medtronic.com. 2. Epic Plus Mitral and Aortic Stented Tissue Valves | Abbott Home Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. 1.5: Safe More . Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Update my browser now. THE List - MRI Safety THE List - MRI Safety Similarly, a tissue graft should be employed over the stapes footplate, or alternatively, over the oval window in stapedectomy procedures to help prevent perilymph fistula or leakage of perilymph. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. The Tri-Ad 2.0 Adams Tricuspid annuloplasty band repairs annular dilatation preserving 3D motion during the cardiac cycle, while providing free wall support and remodeling. To safeguard against postoperative sensorineural hearing loss, extreme care must be taken to avoid traumatizing the inner ear structures by unnecessarily contacting the inner ear structures with surgical instruments or the implant(s) or through the removal of perilymph from the vestibule. Various reports6-9have shown that the MB is a safe and well-performing device in the medium and intermediate terms. Published clinical experience demonstrates impressive long-term performance, including in patients under 60 years. 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. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. Sensorineural deafness due to trauma during surgery, Post surgery displacement of the implant due to the development of scar tissue, To avoid postoperative vertigo and/or loss of inner ear functions, the surgeon should carefully assess the length of the implant in relation to the depth of the middle ear vestibule. This includes: Handle (234 mm length) pliant, without locknut to be used with Mosaic or Mosaic Ultra prostheses, Handle (368 mm length) pliant, without locknut to be used with Mosaic or Mosaic Ultra prostheses, Mosaic Mitral Obturator Set (no handles, no tray). The Simplici-T annuloplasty system offers a first-of-its-kind approach to mitral and tricuspid valve repair. With an updated browser, you will have a better Medtronic website experience. Patients 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. INDICATIONS, SAFETY, AND WARNINGS Mosaic and Mosaic Ultra Bioprostheses Indications for Use For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. ), Clogging of the tube which may require removal and replacement (membrane-style tubes are more susceptible to this complication and only for use in ears evacuated of effusion), Persistent perforation of the tympanum after tube extrusion, Granulomatosis reaction of the tympanum necessitating tube removal, Failure of the tube to self-extrude requiring medical intervention for removal, Allergic reaction may occur in patients with metals sensitivity, Dislocation of the tube into the middle ear cavity, The surgeon is encouraged to carefully choose a tube size, style, and material to meet the needs of each specific clinical situation, while minimizing adverse effects, Larger tube diameters and increasing flange size may increase the chances of prolonged tube retention and/or residual perforation. This device has been approved as a humanitarian use device (HUD) in the United States. The hazard alert and recall only affect the Medtronic Mosaic Porcine Aortic Bioprosthesis Model 305 (all sizes and configurations, Standard and Ultra) and its associated sizing materials. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). (From Wikipedia.com), The results of numerous investigations have demonstrated that metal-containing valves. Orienting the bioprosthesis in the annulus such that the green suture marker is directed approximately toward the right fibrous trigone should position the widest intercommissural space appropriately. August 2020;110(2):508-515. Avoid packing external canal with adherent dressings or applying excessive pressure. Protects tissue from inadvertent damage and prevents entanglement with the sub-valvular apparatus. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were . No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The valve you know and trust continues to evolve Built upon the proven SAPIEN platform, the SAPIEN 3 Ultra transcatheter heart valve is designed with your patient's future needs in mind. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. MeroGelOtologic Packing is a space-occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. Freestyle is our most physiologic valve. 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. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. This problem has occurred at a rate of 0.33% (3.3 reports per 1000 aortic valves). Your cardiac surgery destination for education, evidence, and innovation. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Products Product names on this page are trademarks or registered trademarks of Medtronic. Avoid packing external ear canal with adherent dressings or applying excessive pressure. Heart Valves - Surgical | Medtronic Society for Medical Physics of the Netherlands (NVKF). EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Medtronic, www.medtronic.com Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach. Object Category Heart Valves and Annuloplasty Rings. Warnings and Precautions. 310C31: Medtronic Mosaic 310 Cinch Mitral Valve, 31mm PMA Monthly approvals from 2/1/2022 to 2/28/2022 Original Total: 1 Design is based on CT data from functional human tricuspid valves. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. 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. The Mosaic bioprosthesis based on more than 30 years of Medtronic tissue-valve design expertise is an excellent choice for surgeons looking for long-lasting durability, exceptional performance and implantability for aortic, mitral, and MICS procedures. The artificial valve incorporates synthetic materials and porcine heart valve tissue. 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, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. 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. MeroGel is contraindicated in patients with hypersensitivity to the product.