View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. 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. Healthcare Professionals Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Download Brochure (opens new window) Product Details Undeniably Durable Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic The. With an updated browser, you will have a better Medtronic website experience. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. If you continue, you may go to a site run by someone else. 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. 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. The Cinch implant system capitalizes on the flexible stent to facilitate valve implantation, particularly through tight patient anatomy: 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), LifeLine Cardiovascular It is meant to closely emulate the native aortic valve, offering excellent hemodynamics, durability, and patient outcomes. Heart Valves and Annuloplasty Rings More. (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: All conditions for use for all implanted devices Valve dimensions and geometry facilitate future ViV procedures. This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were . A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. 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 The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. If you continue, you may go to a site run by someone else. Home The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. After use, dispose according to applicable national practice. MRI safety information | Edwards Lifesciences Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Mosaic and Mosaic Ultra Bioprostheses. The EpiDiscTM Perforation Patch Kitis intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. After use, dispose according to applicable national practice. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. The artificial valve incorporates synthetic materials and porcine heart valve tissue. The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." We are always looking for ways to improve our website. A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. 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. With an updated browser, you will have a better Medtronic website experience. 3: Conditional 5 More. (From Wikipedia.com), The results of numerous investigations have demonstrated that metal-containing valves. Cardiovascular The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Mosaic & Mosaic Ultra Bioprostheses Sealing skirt technology Now featuring a ~40% taller *, textured polyethylene terephthalate (PET) outer skirt. 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. Home LifeLine CardioVascular Technical Support, 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. 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) Protects tissue from inadvertent damage and prevents entanglement with the sub-valvular apparatus. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Mosaic and Mosaic Ultra Bioprostheses - Surgical Heart Valves - Medtronic 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. Healthcare Professionals In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. View indications, safety, and warnings for the NIMNerve Integrity Monitoring Systems. Heart Valves and Annuloplasty Rings More. 310C31: Medtronic Mosaic 310 Cinch Mitral Valve, 31mm It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. Warnings and Precautions. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Healthcare Professionals It also: Our exclusive Physiologic Fixation* process mitigates biomechanical failures and promotes long-term valve durability by: Valve dimensions and geometryfacilitate future TAV-in-SAVreplacements. Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. "MR Conditional" mitral annuloplasty device on chest x-ray. 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. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. Home To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. 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. 2. Warning: Persons allergic to cobalt-chromium . Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 1220016001 Rev. 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). 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. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. Product details Undeniably durable Safety Info ID# Safety Topic / Subject Article Text 179: . 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. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. Indications, Safety, and Warnings Product Details Medtronic Open Pivot Aortic Valved Graft (AVG) "MR Conditional" Carillon Mitral Contour Device in coronary sinus. 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. Home 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. Patients 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 Xomed ossicular prostheses are indicated for the functional restoration of sound energy conduction in the middle ear as reconstructive devicesor artificial replacement for the natural ossicles of the middle ear. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. It is recommended that EpiFilm be used immediately after the opening of the pouch; discard any unused portion of the device. Healthcare Professionals The physician must exercise medical judgement and consider the patients complete medical history. Note: Manuals can be viewed using a current version of any major internet browser. Update my browser now. MeroGel is contraindicated in patients with hypersensitivity to the product. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. Less information (see less). As reported in theMosaic bioprostheis Instructions for Use. 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. Mosaic and Mosaic Ultra Bioprostheses. Epic Plus Mitral and Aortic Stented Tissue Valves | Abbott 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. Heart Valves - Surgical | Medtronic Heart Valves Surgical At one time worries existed that an electromagnetic phenomenon known as the "Lenz effect" could inhibit the opening and closing of valves (such as the Bjrk-Shiley) made of metal disks or leaflets. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. 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. This problem has occurred at a rate of 0.33% (3.3 reports per 1000 aortic valves). Provides improved visibility for proper implant orientation, which may reduce the risk of complications. Even very old stainless steel valves are likewise considered of no danger in MRI. 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). 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.
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