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medtronic mosaic valve mri safety

The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. Aortic and Mitral Valve Replacement The Mosaic valve reflects the asymmetry of the native porcine valve. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Healthcare Professionals 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. Your use of the other site is subject to the terms of use and privacy statement on that site. * Compared to the Edwards SAPIEN 3 valve Update my browser now. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. 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 artificial valve incorporates synthetic materials and porcine heart valve tissue. It is possible that these complications could lead to reoperation, explantation, permanent disability, and death. Medtronic Neurosurgery Goleta, CA. For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Sapien* device deployed inside Mosaic mitral. 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. Please help keep this site free for everyone in the world! With an updated browser, you will have a better Medtronic website experience. March 2018;105(3):763-769. It is meant to closely emulate the native aortic valve, offering excellent hemodynamics, durability, and patient outcomes. 3.0: Safe More . With an updated browser, you will have a better Medtronic website experience. Design is based on CT data from functional human tricuspid 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. It is possible that some of the products on the other site are not approved in your region or country. 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. "MR Conditional" Carillon Mitral Contour Device in coronary sinus. Warnings and Precautions. 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. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. Object Status Conditional 5. The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. AOA Tissue Treatment Video The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. The physician must exercise medical judgement and consider the patients complete medical history. 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. If you continue, you may go to a site run by someone else. Your report will contribute to the TGA's monitoring of these products. Valve dimensions and geometry facilitate future ViV procedures. 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. 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. Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach. After use, dispose according to applicable national practice. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Product names on this page are trademarks or registered trademarks of Medtronic. The SimuForm ring is elevating mitral repair its flexible anterior partaccommodates anterior motion, while the semi-rigid posterior part enables remodeling. 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) Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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. 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 Click OK to confirm you are a Healthcare Professional. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. The Contour 3D remodeling ring is anatomically shaped. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. See how the external tissue wrap on the Evolut PRO TAVI performs. Object Category Heart Valves and Annuloplasty Rings. Reduced hearing or total deafness is at risk in such cases. Home Safety of silver oxide-impregnated Silastic tympanostomy tubes. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Long-Term Outcomes of Mosaic versus Perimount Mitral Replacements: 17-Year Follow Up of 940 Implants. Medtronic, www.medtronic.com With an updated browser, you will have a better Medtronic website experience. Update my browser now. It is recommended that EpiDisc be used immediately after the opening of the pouch; discard any unused portion of the device. Healthcare Professionals 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. This device has been approved as a humanitarian use device (HUD) in the United States. If you have not been contacted or want to order the new materials directly, contact Medtronic Australasia on 1800 668 670. Even very old stainless steel valves are likewise considered of no danger in MRI. EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. The Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. Subsequent surgical procedures may be required to correct these conditions if possible. (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 "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. PRODUCT DETAILS EXCEPTIONAL DESIGN 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 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. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. It is important to consult the full system manuals for the most updated information. , chronic renal failure, hyperparathyroidism). 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. 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. Note: Manuals can be viewed using a current version of any major internet browser. Freestyle is our most physiologic valve. 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. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. Home 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. LifeLine CardioVascular Technical Support, 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. Consumers and health professionals are encouraged to report problems with medical devices. As reported in theMosaic bioprostheis Instructions for Use. With an updated browser, you will have a better Medtronic website experience. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. The Tri-Ad 2.0 Adams tricuspid annuloplasty band repairs annular dilatation, preserving 3-D motion during the cardiac cycle while providing free wall support and remodeling. Beute T, Goehler M, Parker J, et al. heart valve Medtronic Inc. Minneapolis, M. 1.5: Safe More. Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Home The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. 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. This site is Exclusively Sponsored by BRACCO. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. 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. Mosaic and Mosaic Ultra Bioprostheses. More information (see more) Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. The valve design allows blood to flow through the annulus encountering only tissue, not obstructive components such as the stent and sewing ring. 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. Cardiovascular Avoid packing external ear canal with adherent dressings or applying excessive pressure. 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). Suitable for Future Interventions Valve dimensions and geometry enable future valve-in-valve (ViV) replacements. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Treatments & Therapies - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. EpiDiscis contraindicated in patients with hypersensitivity to the product. With an updated browser, you will have a better Medtronic website experience. 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. Indications, Safety, and Warnings. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. It is recommended that EpiFilm be used immediately after the opening of the pouch; discard any unused portion of the device. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Click OK to confirm you are a Healthcare Professional. 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. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA *Third-party brands are trademarks of their respective owners. A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Note: Manuals can be viewed using a current version of any major internet browser. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Higher-than-expected transvalvular gradients (>25 mmHg) associated with the Mosaic Procine Aortic Bioprosthesis Model 305 have occurred at a rate of 0.33% (3.3 reports per 1000 aortic implants). Mosaic Mitral Bioprosthesis Model 310 is not affected. 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. Mosaic and Mosaic Ultra Bioprostheses. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. They are classified as either bioprosthetic or mechanical. This website provides excerpts from our user manuals. Product details Undeniably durable 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. 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. Mosaic Porcine Bioprosthesis. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. If you continue, you may go to a site run by someone else. 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. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. MeroGel is contraindicated in patients with hypersensitivity to the product. View indications, safety, and warnings for the NIMNerve Integrity Monitoring Systems. 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. View indications, safety, and warnings for the IndigoOtologic Drill. 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. This problem has occurred at a rate of 0.33% (3.3 reports per 1000 aortic valves). Heart Valves Surgical 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. MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. 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. Module 1: MRI in patients with a prosthetic heart valve, annuloplasty. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Hancock Pericardial . 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. 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. 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. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Ann Thorac Surg. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. The issue is not common, affecting 0.33% of aortic implants using the Mosaic Porcine Aortic Bioprosthesis Model 305. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). Home AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. The EpiDiscTM Perforation Patch Kitis intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. Various reports6-9have shown that the MB is a safe and well-performing device in the medium and intermediate terms. Heart Valves and Annuloplasty Rings More. "MR Conditional" mitral annuloplasty device on chest x-ray. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown. However, the popular Carpentier-Edwards (. 1.5,3: Safe More. 3: Conditional 5 More. Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert for its Mosaic Porcine Aortic Bioprosthesis Model 305 due to the potential for implanting oversized valves. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. Avoid packing external canal with adherent dressings or applying excessive pressure. The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. 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. 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. Product names on this page are trademarks or registered trademarks of Medtronic. Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. Your cardiac surgery destination for education, evidence, and innovation. 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

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