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 Society for Medical Physics of the Netherlands (NVKF). 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. The physician must exercise medical judgement and consider the patients complete medical history. INDICATIONS, SAFETY, AND WARNINGS Mosaic and Mosaic Ultra Bioprostheses Indications for Use For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. With an updated browser, you will have a better Medtronic website experience. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The artificial valve incorporates synthetic materials and porcine heart valve tissue. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolyticanemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. "MR Conditional" mitral annuloplasty device on chest x-ray. 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) AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Accelerated structural 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, or hyperparathyroidism). For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. 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. It is important to consult the full system manuals for the most updated information. With an updated browser, you will have a better Medtronic website experience. 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. Note: Manuals can be viewed using a current version of any major internet browser. Note green deployment catheter. 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). Note: Manuals can be viewed using a current version of any major internet browser. (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 MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. Download Brochure (opens new window) Product Details Undeniably Durable The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 1.5, 3: . 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. The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. , chronic renal failure, hyperparathyroidism). Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. Healthcare Professionals 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. Published clinical experience demonstrates impressive long-term performance, including in patients under 60 years. Can some patients with cardiac pacemakers undergo MRI. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. 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. Ann Thorac Surg. Heart Valves Surgical Patients The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Guideline use of MRI in patients with implants. Home For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Object Category Heart Valves and Annuloplasty Rings. 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. 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. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Viewed from the inflow aspect, the widest intercommissural space of the Mosaic lies between the green suture marker and the first commissure post in the counterclockwise direction. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient. First introduced in the 1980s, Hancock II is a second-generation valve with more than 25 years of clinical experience. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. This device has been approved as a humanitarian use device (HUD) in the United States. Update my browser now. If you continue, you may go to a site run by someone else. Warning: Persons allergic to cobalt-chromium . Provides improved visibility for proper implant orientation, which may reduce the risk of complications. MeroGel is contraindicated in patients with hypersensitivity to the product. Subsequent surgical procedures may be required to correct these conditions if possible. Assists implantation with clear markings for proper orientation. As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. View indications, safety, and warnings for the IndigoOtologic Drill. The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. They are classified as either bioprosthetic or mechanical. Click OK to confirm you are a Healthcare Professional. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Biomaterials, Nasal Packing & Ear Packing Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. 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. The Mosaic valve reflects the asymmetry of the native porcine valve. Diagram of "MR Conditional" mitral valve annuloplasty ring sutured into place. Home Safety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version . Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism ( e.g. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Ear, Nose & Throat 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. It is possible that some of the products on the other site are not approved in your region or country. The following postoperative precautionary measures are recommended: Hydroxylapatite is the basic inorganic constituent of living bone tissue. ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. Your report will contribute to the TGA's monitoring of these products. "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. It is possible that these complications could lead to reoperation, explantation, permanent disability, and death. Sapien* device deployed inside Mosaic mitral. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. Technical Support. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were . With an updated browser, you will have a better Medtronic website experience. Indications, Safety, and Warnings. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. Products We pay our respects to them and their cultures, and to all Elders both past and present. EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. 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 Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). View indications, safety, and warnings for the IPCSystem (lntegrated Power Console). 3: Conditional 5 More. 1C. Cardiovascular Home Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma. Contegra is an integrated valved conduit for reconstruction or replacement of the natural right ventricular outflow tract (RVOT) or replacement of a failed homograft or composite pulmonary conduit. Design is based on CT data from functional human tricuspid valves. Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. 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. Home Ann Thorac Surg. 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. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Note: Manuals can be viewed using a current version of any major internet browser. 1220016001 Rev. Treatments & Therapies With an updated browser, you will have a better Medtronic website experience. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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). Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA If using an MRI device, see the MRI technical manual . Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Avoid packing external ear canal with adherent dressings or applying excessive pressure. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain.
