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. 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. Heart Valves and Annuloplasty Rings More. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. Surgical Heart Valve Repair and Replacement AOA Tissue Treatment Video The Contour 3D remodeling ring is anatomically shaped. 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. 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. Sapien* device deployed inside Mosaic mitral. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Home 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 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. Cardiovascular Am J Oto. (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. The SimuForm ring is elevating mitral repair its flexible anterior partaccommodates anterior motion, while the semi-rigid posterior part enables remodeling. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Ann Thorac Surg. After use, dispose according to applicable national practice. Products The artificial valve incorporates synthetic materials and porcine heart valve tissue. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown. Update my browser now. As reported in theMosaic bioprostheis Instructions for Use. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). Heart Valves and Annuloplasty Rings More. "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. MeroGel is contraindicated in patients with hypersensitivity to the product. Important Safety Information. 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. 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. March 2018;105(3):763-769. Your report will contribute to the TGA's monitoring of these products. For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Smooth, even brushing strokes should prevent inadvertent breakage. Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve Avoid packing external canal with adherent dressings or applying excessive pressure. Contraindications None known. 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. Hancock Pulmonic Conduit Model 105 Medtronic, Inc. www.Medtronic.com. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Chole RA and Brummet RE, et al. The Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. It may also be used to replace a previously implanted prosthetic mitral valve. 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. 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). View indications, safety, and warnings for the Fusion ENT Navigation System. Even very old stainless steel valves are likewise considered of no danger in MRI. If using an MRI device, see the MRI technical manual . EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Update my browser now. 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. Product names on this page are trademarks or registered trademarks of Medtronic. 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. Published clinical experience demonstrates impressive long-term performance in all age groups. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 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. 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. Additional factors that may contribute to durability are: The benefits of AOA tissue treatment have been demonstrated through animal testing. Suitable for Future Interventions Valve dimensions and geometry enable future valve-in-valve (ViV) replacements. Safety Info ID# Safety Topic / Subject Article Text 179: . After use, dispose according to applicable national practice. Patients with an INR of 1.5-2.0 had a >60% reduction in bleeding events and no increase in TE compared to patients with an INR of 2.0-3.0.*. Complications which may occur include, but are not limited to: A high degree of surgicalskill is required for the proper implantation of any ossicular prostheses. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. First introduced in the 1980s, Hancock II is a second-generation valve with more than 25 years of clinical experience. Note: Manuals can be viewed using a current version of any major internet browser. You just clicked a link to go to another website. Mosaic & Mosaic Ultra Bioprostheses For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. After use, dispose according to applicable national practice. The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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) Product names on this page are trademarks or registered trademarks of Medtronic. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Products 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. (Care should be taken to avoid water entering the ear. 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. Ann Thorac Surg. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. 1.5, 3: . Be alert to the issue in your clinical decision-making and consider referring the patient to a relevant specialist, if required. With an updated browser, you will have a better Medtronic website experience. The Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. They are classified as either bioprosthetic or mechanical. The following postoperative precautionary measures are recommended: Hydroxylapatite is the basic inorganic constituent of living bone tissue. The Mosaic valve reflects the asymmetry of the native porcine valve. ), 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. The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). Cardiovascular 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. Update my browser now. Mosaic Porcine Bioprosthesis. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. Healthcare Professionals Instructions for Use. The Contour 3Dannuloplasty ring is a remodeling ring with a physiological tricuspid valve shape a 2-D shape and 3-D curvature based on CT data from functional tricuspid valves. Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. Products Sealing skirt technology Now featuring a ~40% taller *, textured polyethylene terephthalate (PET) outer skirt. PRODUCT DETAILS EXCEPTIONAL DESIGN 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. March 2018;105(3):763-769. In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. There is a risk non sterile product and patient infection, in case any unutilized portions of product were to be re-used after first application. "MR Conditional" mitral annuloplasty device on chest x-ray. 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%).
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