AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. Read MR Safety Disclaimer Before Proceeding, Currentlyavailable valves have either one or two tilting disks. 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. If you continue, you may go to a site run by someone else. The EpiDiscTM Perforation Patch Kitis intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve Cardiovascular 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. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. With an updated browser, you will have a better Medtronic website experience. Healthcare Professionals Roots arepressurized at 40 mm Hg with glutaraldehyde. Aortic and Mitral Valve Replacement 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. Update my browser now. See how the external tissue wrap on the Evolut PRO TAVI performs. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. More information (see more) This site is Exclusively Sponsored by BRACCO. At a minimum, the following precautions must be taken: Following surgery, both surgeon and patient must be alert to any sign of adverse effects from surgery and the patient should be advised of the proper care of the operative ear. Advanced Discussion (show/hide) References 1.5,3: Safe More. Respiratory, 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. Click OK to confirm you are a Healthcare Professional. Heart Valves Surgical. 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. A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. View indications, safety, and warnings for the NIMNerve Integrity Monitoring Systems. Product Details. Heart Valves and Annuloplasty Rings More. 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. Consumers and health professionals are encouraged to report problems with medical devices. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. They are classified as either bioprosthetic or mechanical. 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. - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. Heart Valves Surgical Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctable injury to the middle ear from trauma, The presence of middle ear infection which could result in displacement of the implant(s), Conductive hearingloss which may be restored by non-invasive methods. Heart Valves and Annuloplasty Rings More. The issue is not common, affecting 0.33% of aortic implants using the Mosaic Porcine Aortic Bioprosthesis Model 305. 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 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. EpiDiscTM Perforation Patch Kitis contraindicated in patients with hypersensitivity to the product. Sealing skirt technology Now featuring a ~40% taller *, textured polyethylene terephthalate (PET) outer skirt. Healthcare Professionals Note: Manuals can be viewed using a current version of any major internet browser. Heart Valves and Annuloplasty Rings More. However, the popular Carpentier-Edwards (. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. March 2018;105(3):763-769. 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. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. Cardiovascular Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. 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. Indications, Safety, & Warnings. 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. Click OK to confirm you are a Healthcare Professional. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Home For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Heart Valves . We are always looking for ways to improve our website. 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. VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification FDA .report PMA PMN De Novo MAUDE GUDID NDC DailyMed Drug Applications MOSAIC GUDID 00613994688996 VALVE 310C31 MOSAIC MIT CINCH US MEDTRONIC, INC. FDA.report GUDID MEDTRONIC, INC. 00613994688996 Beute T, Goehler M, Parker J, et al. 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. Ann Thorac Surg. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Smooth, even brushing strokes should prevent inadvertent breakage. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. 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. With an updated browser, you will have a better Medtronic website experience. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. Diagram of "MR Conditional" mitral valve annuloplasty ring sutured into place. 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. Note: Manuals can be viewed using a current version of any major internet browser. "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. Assists implantation with clear markings for proper orientation. Object Status Conditional 5. Products Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. The Streamline family from Medtronic is designed for post-surgical temporary pacing. The. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 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. 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. Published clinical experience demonstrates impressive long-term performance in all age groups. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. With an updated browser, you will have a better Medtronic website experience. Orienting the bioprosthesis in the annulus such that the green suture marker is directed approximately toward the right fibrous trigone should position the widest intercommissural space appropriately. 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. 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. Home 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 Profile 3D annuloplasty system has a unique asymmetrical 3-D remodeling ring design based on the annular geometry of normal human mitral annuli. Indications, Safety, and Warnings Product Details Medtronic Open Pivot Aortic Valved Graft (AVG) MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. August 2020;110(2):508-515. Company Name: MEDTRONIC, INC. Primary DI Number: 00885074253244 Issuing Agency: GS1 Commercial Distribution End Date: August 29, 2016 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use Device Description: VALVE 305U23 MOSAIC AOR ULTRA US CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers We pay our respects to them and their cultures, and to all Elders both past and present. First introduced in the 1980s, Hancock II is a second-generation valve with more than 25 years of clinical experience. 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. 3: Conditional 5 More. , chronic renal failure, hyperparathyroidism). Warning: Persons allergic to cobalt-chromium . Mosaic and Mosaic Ultra Bioprostheses. Update my browser now. 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 Additional factors that may contribute to durability are: The benefits of AOA tissue treatment have been demonstrated through animal testing. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Accelerated 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, hyperparathyroidism). Various reports6-9have shown that the MB is a safe and well-performing device in the medium and intermediate terms. Update my browser now. Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). 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. Home Medtronic, www.medtronic.com Strength 3. Mosaic Mitral Bioprosthesis Model 310 is not affected. Avoid packing external ear canal with adherent dressings or applying excessive pressure. Mosaic 29 Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Design is based on CT data from functional human tricuspid valves. With an updated browser, you will have a better Medtronic website experience. Warnings and Precautions. 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). Instructions for Use. Treatments & Therapies It is recommended that EpiFilm be used immediately after the opening of the pouch; discard any unused portion of the device. ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. With an updated browser, you will have a better Medtronic website experience. A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. 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). Note: Manuals can be viewed using a current version of any major internet browser. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Medtronic, Inc. 2018. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Healthcare Professionals Warnings / Precautions / Adverse Events Avoid packing external canal with adherent dressings or applying excessive pressure. 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. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. 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). Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Medtronic Australasia is recalling the resources and will replace them with updated versions. 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. With an updated browser, you will have a better Medtronic website experience. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Hancock Pulmonic Conduit Model 105 Medtronic, Inc. www.Medtronic.com. The Simplici-T annuloplasty system offers a first-of-its-kind approach to mitral and tricuspid valve repair. 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.*. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Products 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. 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. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. It is possible that some of the products on the other site are not approved in your region or country. Avoid packing external ear canal with adherent dressings or applying excessive pressure. 1.5: Safe More . 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. ), 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 Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. You just clicked a link to go to another website. Less information (see less). Carpentier-Edwards annuloplasty rings, Models 4400 and 4500, marketed from 1980 to 1983, were made of stainless steel. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. MeroGel is contraindicated in patients with hypersensitivity to the product. Update my browser now. The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." It is important to consult the full system manuals for the most updated information. Healthcare Professionals The Mosaic valve reflects the asymmetry of the native porcine valve. With an updated browser, you will have a better Medtronic website experience. Heart Valves Surgical. Biomaterials, Nasal Packing & Ear Packing 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). The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. 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 Suitable for Future Interventions Valve dimensions and geometry enable future valve-in-valve (ViV) replacements. Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. The valve design allows blood to flow through the annulus encountering only tissue, not obstructive components such as the stent and sewing ring. Products 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. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. If you continue, you may go to a site run by someone else. 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. 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. View indications, safety, and warnings for the Fusion ENT Navigation System. However,the use of cartilage or other suitable autogenous tissue as an interface between the implant and the tympanic membrane should be left to the surgeons experiences and preferences. 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. 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. Am J Oto. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. Product names on this page are trademarks or registered trademarks of Medtronic. Be alert to the issue in your clinical decision-making and consider referring the patient to a relevant specialist, if required. Patients

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