This site is Exclusively Sponsored by BRACCO. Avoid packing external ear canal with adherent dressings or applying excessive pressure. If you continue, you may go to a site run by someone else. MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. Subsequent surgical procedures may be required to correct these conditions if possible. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. The Mosaic valve reflects the asymmetry of the native porcine valve. Ann Thorac Surg. 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). Download Brochure (opens new window) Product Details Undeniably Durable Viewed from the inflow aspect, the widest intercommissural space of the Mosaic lies between the green suture marker and the first commissure post in the counterclockwise direction. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. PDF Guidelines for Managing Patients with Heart Valve Prostheses - ISMRM The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. March 2018;105(3):763-769. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Click OK to confirm you are a Healthcare Professional. Update my browser now. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Reults, based on almost 10 years of clinical experience using dense hydroxylapatite in the middle ear, suggest that implants can be placed in direct contact with the tympanic membrane without the added risk of extrusion. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Biomaterials, Nasal Packing & Ear Packing, View indications, safety, and warnings for MeroGel, View indications, safety, and warnings for the IndigoOtologic Drill, View indications, safety, and warnings for the IPC, View indications, safety, and warnings for the NIM, OSSICULAR PROSTHESES (MIDDLE EAR AND STAPES IMPLANTS), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. A subset of these valves have required explantation within five years of implantation at an overall occurrence rate of 0.1% (one explant per 1000 aortic implants). 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. Important Safety Information. Object Info: - MRI Safety With an updated browser, you will have a better Medtronic website experience. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. Company Name: MEDTRONIC, INC. Primary DI Number: 00885074253244 Issuing Agency: GS1 Commercial Distribution End Date: August 29, 2016 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use Device Description: VALVE 305U23 MOSAIC AOR ULTRA US CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers 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. Cardiovascular Advanced Discussion (show/hide) References The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. We are always looking for ways to improve our website. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown. Please help keep this site free for everyone in the world! Additional factors that may contribute to durability are: Our innovative Cinch implant system furthercapitalizes on the valves flexible stent to facilitatevalve implantation, particularly through a tightsinotubular space. (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus. Safety Info ID# Safety Topic / Subject Article Text 179: . Module 1: MRI in patients with a prosthetic heart valve, annuloplasty. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Magnetic Resonance Imaging (MRI) PRECAUTIONS:For ossicular prostheses with metal components: Chronic otitis media with effusion characterized as serous, mucoid, or purulent, Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies, A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus, Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction, Cases of otitis media which respond favorably to drug therapy alone, Cases involving chronic otitis medica with effuctions should not be treated by insertion of membrane-style tubes, Cases of otitis media in which, in the medical judgment of the surgeon, a myringotomy alone or tympanocentesis will suffice as treatment for the condition, The middle ear may develop subsequent secondary infections from either water or airborne pathogens. More information (see more) There is a risk of non-sterile product and patient infection, in case any unutilized portions of product were to be re-used after first application. Products THE List - MRI Safety FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Biomaterials, Nasal Packing & Ear Packing AccessGUDID - DEVICE: MOSAIC ULTRA (00885074253244) PRODUCT DETAILS EXCEPTIONAL DESIGN VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification Products Home Technical Support. 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. Chole RA and Brummet RE, et al. View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. Central/Eastern Europe, Middle East & Africa, Next-generation flexible polymer stent that allows for absorption of stress produced during the cardiac cycle, Physiologic Fixation process that minimizes the stress applied to the leaflets during fixation*, Has stent posts that deflect to allow for easierknot tying near the posts in aortic replacements, Facilitates minimally invasive procedures, Improvingpreservation of valve structure and leaflet function, allowing it to function similar to a native valve, Allowing leaflets to remain soft and flexible which protects the tissue from cyclic fatigue, Roots are pressured at 40 mm Hg with glutaraldehyde, Radiopaque stent post eyelets, which provide visible coaxial markers during TAV-in-SAVprocedures, MR conditional, nonmetallic frame mitigates risk of corrosion between SAV and TAV stent materials, Interior-mounted leaflets mitigate potential risk of coronary obstruction. With an updated browser, you will have a better Medtronic website experience. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Cardiovascular Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Heart Valves . The Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. 1.5, 3: . The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. Heart Valves Surgical. With an updated browser, you will have a better Medtronic website experience. 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