For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 2. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. It may also be used to replace a previously implanted prosthetic mitral valve.
The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Avoid packing external ear canal with adherent dressings or applying excessive pressure.
Reduced hearing or total deafness is at risk in such cases. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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 MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery.
This site is Exclusively Sponsored by BRACCO. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown. Mosaic and Mosaic Ultra Bioprostheses - Surgical Heart Valves - Medtronic
Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. The operative ear is the better or only hearing ear. The SimuForm ring is elevating mitral repair its flexible anterior partaccommodates anterior motion, while the semi-rigid posterior part enables remodeling. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." 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. Bioprostheses for Heart Valve Replacement - Medtronic
Various reports6-9have shown that the MB is a safe and well-performing device in the medium and intermediate terms. It is possible that some of the products on the other site are not approved in your region or country. The artificial valve incorporates synthetic materials and porcine heart valve tissue. 3.0: Safe More . For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals.
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AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com.
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. The physician must exercise medical judgement and consider the patients complete medical history. EpiDiscOtologic Laminais intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. With an updated browser, you will have a better Medtronic website experience. Cardiovascular
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Mosaic & Mosaic Ultra Bioprostheses
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. Products 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. However, the popular Carpentier-Edwards (. Federal law (USA) restricts this device to sale by or on the order of a physician. (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus.
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. Sapien* device deployed inside Mosaic mitral.
To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. 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. After use, dispose according to applicable national practice. Object Info: - MRI Safety This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T.
Medtronic, www.medtronic.com 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. The. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. Medtronic MRI Resource Library: Home March 2018;105(3):763-769. This website provides excerpts from our user manuals. 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. Products
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 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. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Beute T, Goehler M, Parker J, et al. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures.
EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical 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. After use, dispose according to applicable national practice.
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. Home
It is possible that these complications could lead to reoperation, explantation, permanent disability, and death.
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. Your report will contribute to the TGA's monitoring of these 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.
"MR Conditional" Carillon Mitral Contour Device in coronary sinus. 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. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Roots arepressurized at 40 mm Hg with glutaraldehyde. In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. Healthcare Professionals Medtronic Australasia is recalling the resources and will replace them with updated versions. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability.
Heart Valves Surgical
For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Cardiovascular It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA Surgical Heart Valve Repair and Replacement Healthcare Professionals Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. EpiDiscTM Perforation Patch Kitis contraindicated in patients with hypersensitivity to the product. The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. With an updated browser, you will have a better Medtronic website experience.
MR safety: cardiac valves - Questions and Answers in MRI View indications, safety, and warnings for the NIMNerve Integrity Monitoring Systems.
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). Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. The TGA cannot give advice about an individual's medical condition. 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
Heart Valves Surgical.
Published clinical experience demonstrates impressive long-term performance in all age groups. Update my browser now. Assists implantation with clear markings for proper orientation.
Heart Valves - Surgical | Medtronic
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 The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. PMA Monthly approvals from 2/1/2022 to 2/28/2022 Original Total: 1
The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. (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
Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. Viewed from the inflow aspect, the widest intercommissural space of the Mosaic lies between the green suture marker and the first commissure post in the counterclockwise direction.
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 It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. 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. Contraindications: None known .
Heart Valves and Annuloplasty Rings More.
On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. Ann Thorac Surg. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally.
FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Cardiovascular
Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. 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. 1995; 16(6):722-724.
The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm.
Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach.
Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Edwards MIRA aortic and mitral mechanical valves Models 3600, 3600f, 3600u, 9600 Edwards Lifesciences LLC www.edwards.com . Advanced Discussion (show/hide) References Mechanical testing of human cardiac tissue: some implications for MRI safety, Translational and rotational forces on heart valve prostheses subjected ex vivo to a 4.7 T MR system, Assessment of magnetic field (4.7T) induced forces on prosthethic heart valves and annuloplasty rings, Prosthetic heart valves: evaluation of magnetic field interactions, heating, and artifacts at 1.5T, State of the art of transcatheter mitral annuloplasty: present and future, Safety of magnetic resonance imaging in cardiac surgery patients: annuloplasty rings, septal occluders, and transcatheter valves (letter and response), 2020 ACC/AHA Guideline for the management of patients with valvular heart disease.
, 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. Biomaterials, Nasal Packing & Ear Packing Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 310C29: Medtronic Mosaic 310 Cinch Mitral Valve, 29mm Update my browser now.
Hazard alert - potential for implanting oversized valves, Information for surgeons and cardiologists, TGA Incident Reporting and Investigation Scheme (IRIS).
The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). Mosaic & Mosaic Ultra Bioprostheses. 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. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.
For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals.
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.
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