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. With an updated browser, you will have a better Medtronic website experience. 1220016001 Rev. Federal law (USA) restricts this device to sale by or on the order of a physician. Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. Pre-6000 series Starr-Edwards valves were once considered contraindicated for MR imaging, but this prohibition has now been removed. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. Physiologic Fixation, our advanced tissue fixation process, to mitigate biomechanical failures and promote long-term valve durability by: Improving preservation of valve structure and leaflet function, allowing it to function similar to a native valve. 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. Design is based on CT data from functional human tricuspid valves. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Healthcare Professionals AccessGUDID - DEVICE: MOSAIC (00613994689061) Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Epic Plus Mitral and Aortic Stented Tissue Valves | Abbott Heart Valves and Annuloplasty Rings More. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. View indications, safety, and warnings for the Fusion ENT Navigation System. 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). For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Edwards MIRA aortic and mitral mechanical valves Models 3600, 3600f, 3600u, 9600 Edwards Lifesciences LLC www.edwards.com . 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. Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. 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. Home Medtronic Open Pivot Mechanical Heart Valves The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. Bioprostheses for Heart Valve Replacement - Medtronic Mosaic and Mosaic Ultra Bioprostheses. 3: Conditional 5 More. Hancock Pericardial . 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. Medtronic, www.medtronic.com On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Less information (see less). 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. PRODUCT DETAILS EXCEPTIONAL DESIGN 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 artificial valve incorporates synthetic materials and porcine heart valve tissue. 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 Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. If there is any suspicion of oval window granuloma or fistuladuring the postoperative recovery period, an emergency exploratory tympanotomy and correction of the condition should be performed immediately. 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. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. Home Extreme caution must be exercised by the surgeon during surgery to safeguard against undesirable results and postoperative complications.implant should be trimmed (or a shorter implant selected) if it is too long for the vestibule to avoid any contact with sensitive inner ear structures. Subsequent surgical procedures may be required to correct these conditions if possible. 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. Cardiovascular Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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.