Advanced Discussion (show/hide) References 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). Products 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). 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. Home It is recommended that EpiDisc be used immediately after the opening of the pouch; discard any unused portion of the device. Indications, Safety, & Warnings. Cardiovascular For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Indications, Safety, and Warnings Product Details Medtronic Open Pivot Aortic Valved Graft (AVG) 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) AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. You just clicked a link to go to another website. Warning: Persons allergic to cobalt-chromium . Various reports6-9have shown that the MB is a safe and well-performing device in the medium and intermediate terms. Home Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. August 2020;110(2):508-515. High-performance stent that allows for absorption of stress produced during the cardiac cycle. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Healthcare Professionals Overview The Mosaic bioprosthesis based on more than 30 years of Medtronic tissue-valve design expertise is a great option for surgeons seeking exceptional long-term durability, excellent hemodynamics, and a smooth implanting experience. Protects tissue from inadvertent damage and prevents entanglement with the sub-valvular apparatus. Warnings and Precautions. 3: Conditional 5 More. 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). Society for Medical Physics of the Netherlands (NVKF). The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. Even very old stainless steel valves are likewise considered of no danger in MRI. "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. After use, dispose according to applicable national practice. Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). 3.0: Safe More . 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. Cardiovascular Products 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%). If using an MRI device, see the MRI technical manual . View indications, safety, and warnings for the Fusion ENT Navigation System. Healthcare Professionals Home Products The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Heart Valves and Annuloplasty Rings More. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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 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. Instructions for Use. 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. With an updated browser, you will have a better Medtronic website experience. 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 Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. It is possible that some of the products on the other site are not approved in your region or country. The. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were . 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. Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach. 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.*. The artificial valve incorporates synthetic materials and porcine heart valve tissue. Avoid packing external canal with adherent dressings or applying excessive pressure. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. 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. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. The Streamline family from Medtronic is designed for post-surgical temporary pacing. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. Please help keep this site free for everyone in the world! The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. If you have not been contacted or want to order the new materials directly, contact Medtronic Australasia on 1800 668 670. 2. 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. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. 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. Hancock bioprosthetic valvedconduits are for the reconstruction of congenital or acquired cardiac and great vessel malformations or pathologies for right-heart applications. The EpiDisc TM Perforation Patch Kitis indicated for use during myringoplastic surgical procedures. 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. "MR Conditional" mitral annuloplasty device on chest x-ray. Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). 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. Consumers and health professionals are encouraged to report problems with medical devices. Update my browser now. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Am J Oto. If there is any suspicion of oval window granuloma or fistuladuring the postoperative recovery period, an emergency exploratory tympanotomy and correction of the condition should be performed immediately. 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. Heart Valves Surgical We update our information and features frequently. We pay our respects to them and their cultures, and to all Elders both past and present. Module 1: MRI in patients with a prosthetic heart valve, annuloplasty. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. Update my browser now. 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). 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. Home March 2018;105(3):763-769. View indications, safety, and warnings for the NIMNerve Integrity Monitoring Systems. 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. 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. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. With an updated browser, you will have a better Medtronic website experience. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. With an updated browser, you will have a better Medtronic website experience. It is important to consult the full system manuals for the most updated information. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Home The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Less information (see less). As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. The physician must exercise medical judgement and consider the patients complete medical history. Healthcare Professionals March 2018;105(3):763-769. A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. It is highly unlikely, however, that anyone with mitral valve disease requiring angioplasty 40 years ago is still alive to be scanned, so I do not worry about the possibility of such a "black swan"event. 1C. 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. Your cardiac surgery destination for education, evidence, and innovation. , chronic renal failure, hyperparathyroidism). The Mosaic valve reflects the asymmetry of the native porcine valve. View indications, safety, and warnings for the IndigoOtologic Drill. This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T. Healthcare Professionals Note: Manuals can be viewed using a current version of any major internet browser. See how the external tissue wrap on the Evolut PRO TAVI performs. For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). 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. Medtronic, Inc. 2018. Cardiovascular A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. 1995; 16(6):722-724. 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. Healthcare Professionals Freestyle is our most physiologic valve. This device has been approved as a humanitarian use device (HUD) in the United States. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Update my browser now. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. Safety Topic / Subject Heart Valves and Annuloplasty Rings. The following postoperative precautionary measures are recommended: Hydroxylapatite is the basic inorganic constituent of living bone tissue. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Subsequent surgical procedures may be required to correct these conditions if possible. Strength 3. View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. Mosaic & Mosaic Ultra Bioprostheses Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. It may also be used to replace a previously implanted prosthetic mitral valve. * Compared to the Edwards SAPIEN 3 valve 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. 1220016001 Rev. 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. This site is Exclusively Sponsored by BRACCO. Suitable for Future Interventions Valve dimensions and geometry enable future valve-in-valve (ViV) replacements. The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." *Third-party brands are trademarks of their respective owners. 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. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. View indications, safety, and warnings for the IPCSystem (lntegrated Power Console). Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. Medtronic Neurosurgery Goleta, CA. Treatments & Therapies (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 (From Wikipedia.com), The results of numerous investigations have demonstrated that metal-containing valves. - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. The Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. 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. Heart Valves and Annuloplasty Rings More. Click OK to confirm you are a Healthcare Professional. Mosaic Porcine Bioprosthesis. With an updated browser, you will have a better Medtronic website experience. Ann Thorac Surg. Medtronic, www.medtronic.com To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Pre-6000 series Starr-Edwards valves were once considered contraindicated for MR imaging, but this prohibition has now been removed. 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). Home Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. If you are located outside the United States, see the device manual (opens new window) for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Roots arepressurized at 40 mm Hg with glutaraldehyde. heart valve Medtronic Inc. Minneapolis, M. 1.5: Safe More. 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. Note green deployment catheter. Carpentier-Edwards annuloplasty rings, Models 4400 and 4500, marketed from 1980 to 1983, were made of stainless steel. EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. Reduced hearing or total deafness is at risk in such cases. (Care should be taken to avoid water entering the ear. Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Download Brochure (opens new window) Product Details Undeniably Durable Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. The EpiDiscTM Perforation Patch Kitis intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. 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. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. 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. Provides improved visibility for proper implant orientation, which may reduce the risk of complications. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. Heart Valves Surgical. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Federal law (USA) restricts this device to sale by or on the order of a physician. Potential Adverse Events: Certain complications may occur with heart valve procedures. 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. 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. The artificial valve incorporates synthetic materials and porcine heart valve tissue. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. 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. 1.5,3: Safe More. 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. MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. Complications which may occur include, but are not limited to: A high degree of surgicalskill is required for the proper implantation of any ossicular prostheses. Product details Undeniably durable They are classified as either bioprosthetic or mechanical. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Long-Term Outcomes of Mosaic versus Perimount Mitral Replacements: 17-Year Follow Up of 940 Implants. After use, dispose according to applicable national practice. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. EpiDiscTM Perforation Patch Kitis contraindicated in patients with hypersensitivity to the product. 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 Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA 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.
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