Mosaic and Mosaic Ultra Bioprostheses - Surgical Heart Valves - Medtronic Important Labeling Information for United States. Carpentier-Edwards annuloplasty rings, Models 4400 and 4500, marketed from 1980 to 1983, were made of stainless steel. 2. EpiDiscis contraindicated in patients with hypersensitivity to the product. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. After use, dispose according to applicable national practice. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. 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 result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Download Brochure (opens new window) Product Details Undeniably Durable In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Heart Valves Surgical For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Assists implantation with clear markings for proper orientation. Avoid packing external ear canal with adherent dressings or applying excessive pressure. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. Mosaic & Mosaic Ultra Bioprostheses. Heart Valves and Annuloplasty Rings More. 310C31: Medtronic Mosaic 310 Cinch Mitral Valve, 31mm Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. (Care should be taken to avoid water entering the ear. Strength 3. Aortic and Mitral Valve Surgery - Important Safety Information - Medtronic Sealing skirt technology Now featuring a ~40% taller *, textured polyethylene terephthalate (PET) outer skirt. However, the popular Carpentier-Edwards (. AccessGUDID - DEVICE: MOSAIC ULTRA (00885074253244) Published clinical experience demonstrates impressive long-term performance in all age groups. Cardiovascular You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. 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. Update my browser now. Warnings / Precautions / Adverse Events To safeguard against postoperative sensorineural hearing loss, extreme care must be taken to avoid traumatizing the inner ear structures by unnecessarily contacting the inner ear structures with surgical instruments or the implant(s) or through the removal of perilymph from the vestibule. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Product names on this page are trademarks or registered trademarks of Medtronic. MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Your report will contribute to the TGA's monitoring of these products. It is possible that these complications could lead to reoperation, explantation, permanent disability, and death. 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. Home Product names on this page are trademarks or registered trademarks of Medtronic. Instructions for Use. 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. Epic Plus Mitral and Aortic Stented Tissue Valves | Abbott 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. The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T. To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. Healthcare Professionals The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. 3.0: Safe More . 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. View indications, safety, and warnings for the Fusion ENT Navigation System. Safety Info ID# Safety Topic / Subject Article Text 179: . Can some patients with cardiac pacemakers undergo MRI. Note: Manuals can be viewed using a current version of any major internet browser. ), 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. Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. 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. THE List - MRI Safety 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. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required. 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. The. "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. Freestyle is our most physiologic valve. 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. Home Object Category Heart Valves and Annuloplasty Rings. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 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. The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Sapien* device deployed inside Mosaic mitral. MRI safety Heart valve products US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. 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 Mosaic Mitral Bioprosthesis Model 310 is not affected. 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. 1C. 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. "MR Conditional" Carillon Mitral Contour Device in coronary sinus. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. , chronic renal failure, hyperparathyroidism). Healthcare Professionals 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. You just clicked a link to go to another website. Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. Heart Valves and Annuloplasty Rings More. Society for Medical Physics of the Netherlands (NVKF). On-X Aortic Heart Valve - Artivion Indications, Safety, and Warnings - Mosaic and Mosaic Ultra - Medtronic Heart Valves - Surgical | Medtronic Cardiovascular Cardiovascular Avoid packing external ear canal with adherent dressings or applying excessive pressure. THE List - MRI Safety Training, education andcollaboration on the treatment of mitral and tricuspidvalve disease. MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. It is recommended that EpiDisc be used immediately after the opening of the pouch; discard any unused portion of the device. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Technical Support. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. Published clinical experience demonstrates impressive long-term performance, including in patients under 60 years. 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) Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. Home Heart Valves and Annuloplasty Rings More. 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. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. As reported in theMosaic bioprostheis Instructions for Use. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. Similarly, a tissue graft should be employed over the stapes footplate, or alternatively, over the oval window in stapedectomy procedures to help prevent perilymph fistula or leakage of perilymph. 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. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. AccessGUDID - DEVICE: MOSAIC (00613994689061) Heart Valves and Annuloplasty Rings More. Hancock bioprosthetic valvedconduits are for the reconstruction of congenital or acquired cardiac and great vessel malformations or pathologies for right-heart applications. The operative ear is the better or only hearing ear. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Bioprostheses for Heart Valve Replacement - Medtronic They are classified as either bioprosthetic or mechanical. It is important to consult the full system manuals for the most updated information. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 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. - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. Medtronic MRI Resource Library: Home 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. Surgical valve treatment for mitral and aortic valve disease The Epic Plus Mitral stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native mitral heart valve. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. March 2018;105(3):763-769. With an updated browser, you will have a better Medtronic website experience. The valve design allows blood to flow through the annulus encountering only tissue, not obstructive components such as the stent and sewing ring. August 2020;110(2):508-515. If you continue, you may go to a site run by someone else. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. The Mosaicbioprosthesis (MB) (Medtronic, Inc.; Minneapolis, Minn) is a 3rd-generation porcine valve that became clinically available in 1994. The artificial valve incorporates synthetic materials and porcine heart valve tissue. (From Wikipedia.com), The results of numerous investigations have demonstrated that metal-containing valves. With an updated browser, you will have a better Medtronic website experience. 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 Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Medtronic Australasia is recalling the resources and will replace them with updated versions. Indications, Safety, & Warnings. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Cardiac surgery education, innovation, and evidence, 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 Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. Design is based on CT data from functional human tricuspid valves. Heart Valves - Surgical | Medtronic