Healthcare Professionals 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. Update my browser now. Heart Valves Surgical. The TGA cannot give advice about an individual's medical condition. Read MR Safety Disclaimer Before Proceeding, Currentlyavailable valves have either one or two tilting disks. Medtronic Manuals: Region "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. Specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, can result in the alteration of normal leaflet movement as blood flowing through the native annulus might not properly match the size and/or shape of the inflow of the Mosaic Porcine Aortic Bioprosthesis Model 305. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). After use, dispose according to applicable national practice. With an updated browser, you will have a better Medtronic website experience. Healthcare Professionals 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. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. Federal law (USA) restricts this device to sale by or on the order of a physician. View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain. THE List - MRI Safety After use, dispose according to applicable national practice. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Freestyle is our most physiologic valve. "MR Conditional" mitral annuloplasty device on chest x-ray. A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. 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. 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. 310C31: Medtronic Mosaic 310 Cinch Mitral Valve, 31mm CVG EMEA Indications, Safety and Warnings | Medtronic In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Edwards MIRA aortic and mitral mechanical valves Models 3600, 3600f, 3600u, 9600 Edwards Lifesciences LLC www.edwards.com . Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 1C. However, the popular Carpentier-Edwards (. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA 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. 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 The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. March 2018;105(3):763-769. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). Be alert to the issue in your clinical decision-making and consider referring the patient to a relevant specialist, if required. Reduced hearing or total deafness is at risk in such cases. Chole RA and Brummet RE, et al. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. If you have not been contacted or want to order the new materials directly, contact Medtronic Australasia on 1800 668 670. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. Hancock Pulmonic Conduit Model 105 Medtronic, Inc. www.Medtronic.com. Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Note green deployment catheter. Note: Manuals can be viewed using a current version of any major internet browser. 1220016001 Rev. Smooth, even brushing strokes should prevent inadvertent breakage. With an updated browser, you will have a better Medtronic website experience. The adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. 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. 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 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. 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. Products A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. The artificial valve incorporates synthetic materials and porcine heart valve tissue. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. 1995; 16(6):722-724. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. The physician must exercise medical judgement and consider the patients complete medical history. * Compared to the Edwards SAPIEN 3 valve The valve design allows blood to flow through the annulus encountering only tissue, not obstructive components such as the stent and sewing ring. The Streamline family from Medtronic is designed for post-surgical temporary pacing. Ann Thorac Surg. To safeguard against postoperative sensorineural hearing loss, extreme care must be taken to avoid traumatizing the inner ear structures by unnecessarily contacting the inner ear structures with surgical instruments or the implant(s) or through the removal of perilymph from the vestibule. It is important to consult the full system manuals for the most updated information. 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. 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 largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Product names on this page are trademarks or registered trademarks of Medtronic. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. MeroGelOtologic Packing is a space-occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. 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. 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. EpiDiscis contraindicated in patients with hypersensitivity to the product. 1.5,3: Safe More. The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. 3: Conditional 5 More. 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). Home Update my browser now. 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) 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. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. Mosaic Mitral Bioprosthesis Model 310 is not affected. On-X Aortic Heart Valve - Artivion Healthcare Professionals Module 1: MRI in patients with a prosthetic heart valve, annuloplasty. Home VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification Note: Manuals can be viewed using a current version of any major internet browser. You just clicked a link to go to another website. Hancock Pericardial . Heart Valves Surgical Heart Valves Surgical Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Assists implantation with clear markings for proper orientation. Instructions for Use. ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. Physiologic Fixation, our advanced tissue fixation process, to mitigate biomechanical failures and promote long-term valve durability by: Improving preservation of valve structure and leaflet function, allowing it to function similar to a native valve. Update my browser now. Mosaic and Mosaic Ultra Bioprostheses. Hancock bioprosthetic valvedconduits are for the reconstruction of congenital or acquired cardiac and great vessel malformations or pathologies for right-heart applications. It is possible that some of the products on the other site are not approved in your region or country. MeroGel is contraindicated in patients with hypersensitivity to the product. 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. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. 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). Mosaic and Mosaic Ultra Bioprostheses. 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. 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. 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. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. 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. ), 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. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Object Info: - MRI Safety 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. Published clinical experience demonstrates impressive long-term performance in all age groups. Cardiovascular 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). Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. Roots arepressurized at 40 mm Hg with glutaraldehyde. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Mosaic & Mosaic Ultra Bioprostheses. Products THE List - MRI Safety Update my browser now. 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. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. 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 Safety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version . Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. With an updated browser, you will have a better Medtronic website experience. 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. Indications, Safety, and Warnings Product Details Medtronic Open Pivot Aortic Valved Graft (AVG) Medtronic, Inc. 2018. 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. All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Heart Valves and Annuloplasty Rings More. (Care should be taken to avoid water entering the ear. Cardiovascular Object Category Heart Valves and Annuloplasty Rings. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. It may also be used to replace a previously implanted prosthetic mitral valve. Subsequent surgical procedures may be required to correct these conditions if possible. Update my browser now. 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 and Mosaic Ultra Bioprostheses - Surgical Heart Valves - Medtronic It is meant to closely emulate the native aortic valve, offering excellent hemodynamics, durability, and patient outcomes. 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. MRI safety information | Edwards Lifesciences (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus. Advanced Discussion (show/hide) References Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. Beute T, Goehler M, Parker J, et al. Click OK to confirm you are a Healthcare Professional. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. View indications, safety, and warnings for the Fusion ENT Navigation System. High-performance stent that allows for absorption of stress produced during the cardiac cycle. Pre-6000 series Starr-Edwards valves were once considered contraindicated for MR imaging, but this prohibition has now been removed. Am J Oto. Important Labeling Information for United States. Medtronic MRI Resource Library: Home Home If you are treating a patient who has received a Mosaic Porcine Aortic Bioprosthesis Model 305, reassure them that it is not common (occurring at a rate of 0.33%). Update my browser now. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. We pay our respects to them and their cultures, and to all Elders both past and present. No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. 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. Heart Valves Surgical. Training, education andcollaboration on the treatment of mitral and tricuspidvalve disease.