Pathologic conditions for which ventilation tubes are indicated include but are not limited to: Some conditions for which ventilation tubes may not be the therapy of choice include: The Medtronic Xomed ActiventAntimicrobial Ventilation Tube was evaluated in a 12-month study in the middle ear of animals.1While the Activent tube was formed of silicone and silver oxide and was shown to be bacteriocidal/bacteriostatic, the study showed that the material produced no significant adverse effects compared to silicone control material. 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. 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. Carpentier-Edwards annuloplasty rings, Models 4400 and 4500, marketed from 1980 to 1983, were made of stainless steel. , chronic renal failure, hyperparathyroidism). Mosaic & Mosaic Ultra Bioprostheses. They are classified as either bioprosthetic or mechanical. Federal law (USA) restricts this device to sale by or on the order of a physician. Contraindications: None known . Cardiovascular Products To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. In a prospective, multicenter, long-term follow-up observational study of 1,029 patients, the following outcomes were reported: Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet related), leak (transvalvular or paravalvular), myocardial infarction nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), stroke, structural deterioration (calcification, leaflet tear, other) thromboembolism, valve thrombosis. AOA Tissue Treatment Video If you, or someone you care for, have received a porcine aortic bioprosthesis and you are concerned about this issue, contact the treating surgeon or cardiologist for advice. 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. Warnings and Precautions. With an updated browser, you will have a better Medtronic website experience. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. The SimuForm ring is elevating mitral repair its flexible anterior partaccommodates anterior motion, while the semi-rigid posterior part enables remodeling. 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). Assists implantation with clear markings for proper orientation. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Ann Thorac Surg. 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. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Update my browser now. Mosaic and Mosaic Ultra Bioprostheses. Medtronic, www.medtronic.com Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. High-performance stent that allows for absorption of stress produced during the cardiac cycle. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Update my browser now. 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. Product names on this page are trademarks or registered trademarks of Medtronic. 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. - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. Healthcare Professionals 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. Heart Valves and Annuloplasty Rings More. If you continue, you may go to a site run by someone else. The Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were . Cardiovascular Product names on this page are trademarks or registered trademarks of Medtronic. Safety of silver oxide-impregnated Silastic tympanostomy tubes. Healthcare Professionals EpiFilmOtologic Lamina is 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. 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. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. Product details Undeniably durable Read MR Safety Disclaimer Before Proceeding, Currentlyavailable valves have either one or two tilting disks. 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. Diagram of "MR Conditional" mitral valve annuloplasty ring sutured into place. 1.5, 3: . 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. Society for Medical Physics of the Netherlands (NVKF). All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. 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. If you have not been contacted or want to order the new materials directly, contact Medtronic Australasia on 1800 668 670. 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. Your report will contribute to the TGA's monitoring of these products. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. If you are treating a patient who has received a Mosaic Porcine Aortic Bioprosthesis Model 305, reassure them that it is not common (occurring at a rate of 0.33%). Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. The Profile 3D annuloplasty system has a unique asymmetrical 3-D remodeling ring design based on the annular geometry of normal human mitral annuli. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. The TGA cannot give advice about an individual's medical condition. Home Biomaterials, Nasal Packing & Ear Packing The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. 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.

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