Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). 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. 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. 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. Serious complications may arise either during or after surgery which may result in irreparable damage to these otologic structures and their functions causing irreversible partial or total loss of hearing. Beute T, Goehler M, Parker J, et al. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. The TGA cannot give advice about an individual's medical condition. 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 proced An investigation has found that the sizing chart and associated sizing tools (known as 'obturators' or 'sizers') may have contributed to the selection of larger-than-optimal implants. Heart Valves Surgical Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. More information (see more) Assists implantation with clear markings for proper orientation. Product Details. The MRI examination must be performed using the following parameters: 1.5-Tesla or 3-Tesla, only Whole body averaged specific absorption rate (SAR) of 2-W/kg, operating in the Normal Operating Mode for the MR system Maximum imaging time, 15 minutes per pulse sequence (multiple sequences per patient are allowed) 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. With an updated browser, you will have a better Medtronic website experience. Warnings and Precautions. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. Medtronic Australasia is recalling the resources and will replace them with updated versions. The Contour 3D remodeling ring is anatomically shaped. Heart Valves and Annuloplasty Rings More. They are classified as either bioprosthetic or mechanical. Safety of silver oxide-impregnated Silastic tympanostomy tubes. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. However,the use of cartilage or other suitable autogenous tissue as an interface between the implant and the tympanic membrane should be left to the surgeons experiences and preferences. Update my browser now. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient. Indications, Safety, and Warnings Product Details Medtronic Open Pivot Aortic Valved Graft (AVG) 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Please help keep this site free for everyone in the world! Safety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version . View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. 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). It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 3.0: Safe More . 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. Home For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Update my browser now. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Instructions for Use. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. This problem has occurred at a rate of 0.33% (3.3 reports per 1000 aortic valves). Even very old stainless steel valves are likewise considered of no danger in MRI. 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 Hazard alert - potential for implanting oversized valves, Information for surgeons and cardiologists, TGA Incident Reporting and Investigation Scheme (IRIS). Indications, Safety, and Warnings. Medtronic, www.medtronic.com The Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. 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). 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. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. Healthcare Professionals The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). Mosaic & Mosaic Ultra Bioprostheses. Published clinical experience demonstrates impressive long-term performance, including in patients under 60 years. Update my browser now. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). Design is based on CT data from functional human tricuspid valves. 1.5, 3: . With an updated browser, you will have a better Medtronic website experience. Mechanical testing of human cardiac tissue: some implications for MRI safety, Translational and rotational forces on heart valve prostheses subjected ex vivo to a 4.7 T MR system, Assessment of magnetic field (4.7T) induced forces on prosthethic heart valves and annuloplasty rings, Prosthetic heart valves: evaluation of magnetic field interactions, heating, and artifacts at 1.5T, State of the art of transcatheter mitral annuloplasty: present and future, Safety of magnetic resonance imaging in cardiac surgery patients: annuloplasty rings, septal occluders, and transcatheter valves (letter and response), 2020 ACC/AHA Guideline for the management of patients with valvular heart disease. - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. Mosaic and Mosaic Ultra Bioprostheses. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Your report will contribute to the TGA's monitoring of these products. This site is Exclusively Sponsored by BRACCO. Heart Valves Surgical. Thus at present, most centers consider all implanted heart valves and annuloplasty rings conditionally safe for MR imaging up to 3.0T, and do not require any waiting period after surgery before they can be scanned. Home Click OK to confirm you are a Healthcare Professional. March 2018;105(3):763-769. It is important to consult the full system manuals for the most updated information. Medtronic Neurosurgery Goleta, CA. Your use of the other site is subject to the terms of use and privacy statement on that site. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). Products View indications, safety, and warnings for the IndigoOtologic Drill. After use, dispose according to applicable national practice. After use, dispose according to applicable national practice. Hancock Pulmonic Conduit Model 105 Medtronic, Inc. www.Medtronic.com. Heart Valves Surgical. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. EpiDiscOtologic Laminais intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. Smooth, even brushing strokes should prevent inadvertent breakage. Products With an updated browser, you will have a better Medtronic website experience. After use, dispose according to applicable national practice. Products If you are located outside the United States, see the device manual (opens new window) for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Surgeons performing middle ear surgery should have received specific training in the reconstruction and replacement of the middle ear ossicles prior to attempting implantation of Medtronic Xomed ossicular prostheses. Reconstruction or replacement of all or part of the ossicular chain may be necessary to correct structural damage of the middle ear ossiclesor conductive hearing loss resulting from a number of pathologic conditions, including but not limited to: Certain conditions may preclude the selection of ossicular prostheses implants as a means of restoring conductive hearing loss including: Surgery of the middle ear involves manipulation of fragile temporal bones and exposes inner ear structures to the risk of surgical trauma and infections. The Mosaic valve reflects the asymmetry of the native porcine valve. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. 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). 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. 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 Product names on this page are trademarks or registered trademarks of Medtronic. Note: Manuals can be viewed using a current version of any major internet browser. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. 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. Contraindications None known. 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. Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. 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.