medtronic mosaic valve mri safety medtronic mosaic valve mri safety

On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. They are classified as either bioprosthetic or mechanical. After use, dispose according to applicable national practice. Home 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. 1.5,3: Safe More. 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. 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. Read MR Safety Disclaimer Before Proceeding, Currentlyavailable valves have either one or two tilting disks. AOA Tissue Treatment Video 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. Cardiovascular Indications, Safety, and Warnings. Mosaic and Mosaic Ultra Bioprostheses. "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. You just clicked a link to go to another website. Heart Valves . 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. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Hancock Pulmonic Conduit Model 105 Medtronic, Inc. www.Medtronic.com. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. Healthcare Professionals Pre-6000 series Starr-Edwards valves were once considered contraindicated for MR imaging, but this prohibition has now been removed. 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. Sealing skirt technology Now featuring a ~40% taller *, textured polyethylene terephthalate (PET) outer skirt. It is recommended that EpiFilm be used immediately after the opening of the pouch; discard any unused portion of the device. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. The. Healthcare Professionals Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Patients Diagram of "MR Conditional" mitral valve annuloplasty ring sutured into place. EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. Note: Manuals can be viewed using a current version of any major internet browser. With an updated browser, you will have a better Medtronic website experience. The Streamline family from Medtronic is designed for post-surgical temporary pacing. 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. 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. Technical Support. Note: Manuals can be viewed using a current version of any major internet browser. 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 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. 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. 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 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. Training, education andcollaboration on the treatment of mitral and tricuspidvalve disease. 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). Products 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.*. 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. 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. It is important to consult the full system manuals for the most updated information. The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. Products We are always looking for ways to improve our website. Heart Valves and Annuloplasty Rings More. Cardiovascular Contraindications None known. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Healthcare Professionals As reported in theMosaic bioprostheis Instructions for Use. Your report will contribute to the TGA's monitoring of these products. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Even very old stainless steel valves are likewise considered of no danger in MRI. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. In the event that minor modifications of a dense H/A head or shaft are required, it is advisable to perform all trimming or contouring with a diamond burr using copious amounts of irrigation. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Beute T, Goehler M, Parker J, et al. Chole RA and Brummet RE, et al. 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. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. MeroGel is contraindicated in patients with hypersensitivity to the product. 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. Warning: Persons allergic to cobalt-chromium . Mosaic & Mosaic Ultra Bioprostheses Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. This website provides excerpts from our user manuals. Note: Manuals can be viewed using a current version of any major internet browser. Home Click OK to confirm you are a Healthcare Professional. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 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). Download Brochure (opens new window) Product Details Undeniably Durable Update my browser now. Long-Term Outcomes of Mosaic versus Perimount Mitral Replacements: 17-Year Follow Up of 940 Implants. 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. 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). PMA Monthly approvals from 2/1/2022 to 2/28/2022 Original Total: 1 Supplements Total: 68 30-Day Notice P200030/S007 02/22/2022 X - 30-Day Notice GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS (CEXC). 1.5, 3: . Safety Info ID# Safety Topic / Subject Article Text 179: . You just clicked a link to go to another website. Assists implantation with clear markings for proper orientation. Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve Am J Oto. 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., chronic renal failure, hyperparathyroidism). ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. Reduced hearing or total deafness is at risk in such cases. With an updated browser, you will have a better Medtronic website 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. See how the external tissue wrap on the Evolut PRO TAVI performs. 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 You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. 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. Less information (see less). It may also be used to replace a previously implanted prosthetic mitral valve. View indications, safety, and warnings for the Fusion ENT Navigation System. The artificial valve incorporates synthetic materials and porcine heart valve tissue. MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. 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. Products Update my browser now. Published clinical experience demonstrates impressive long-term performance, including in patients under 60 years. 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. Roots arepressurized at 40 mm Hg with glutaraldehyde. MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. PRODUCT DETAILS EXCEPTIONAL DESIGN 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. This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T. Ann Thorac Surg. The EpiDiscTM Perforation Patch Kitis intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. The issue is not common, affecting 0.33% of aortic implants using the Mosaic Porcine Aortic Bioprosthesis Model 305. Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach. If you continue, you may go to a site run by someone else. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Mosaic & Mosaic Ultra Bioprostheses. 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. It also: Our exclusive Physiologic Fixation* process mitigates biomechanical failures and promotes long-term valve durability by: Valve dimensions and geometryfacilitate future TAV-in-SAVreplacements. The Profile 3D annuloplasty system has a unique asymmetrical 3-D remodeling ring design based on the annular geometry of normal human mitral annuli. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). Hancock Pericardial . This site is Exclusively Sponsored by BRACCO. If you continue, you may go to a site run by someone else. Carpentier-Edwards annuloplasty rings, Models 4400 and 4500, marketed from 1980 to 1983, were made of stainless steel. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. If using an MRI device, see the MRI technical manual . Subsequent surgical procedures may be required to correct these conditions if possible. (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. Contraindications: None known . Instructions for Use. *Third-party brands are trademarks of their respective owners. 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 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. 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 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. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Cardiovascular 1220016001 Rev. 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. Medtronic Neurosurgery Goleta, CA. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. Federal law (USA) restricts this device to sale by or on the order of a physician. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were . Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown. Home Ann Thorac Surg. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA Society for Medical Physics of the Netherlands (NVKF). (From Wikipedia.com), The results of numerous investigations have demonstrated that metal-containing valves. Heart Valves Surgical The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). August 2020;110(2):508-515. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Important Labeling Information for United States. The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. If you, or someone you care for, have received a porcine aortic bioprosthesis and you are concerned about this issue, contact the treating surgeon or cardiologist for advice. Suitable for Future Interventions Valve dimensions and geometry enable future valve-in-valve (ViV) replacements. 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. 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 (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus. EpiDiscTM Perforation Patch Kitis contraindicated in patients with hypersensitivity to the product. We update our information and features frequently. Protects tissue from inadvertent damage and prevents entanglement with the sub-valvular apparatus. 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. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. The operative ear is the better or only hearing ear. First introduced in the 1980s, Hancock II is a second-generation valve with more than 25 years of clinical experience. It is possible that some of the products on the other site are not approved in your region or country. 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.