The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. Contraindications: None known . Warnings and Precautions. Cardiovascular
Contegra is an integrated valved conduit for reconstruction or replacement of the natural right ventricular outflow tract (RVOT) or replacement of a failed homograft or composite pulmonary conduit.
"MR Conditional" mitral annuloplasty device on chest x-ray. Freestyle is our most physiologic valve. 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.
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, 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. Hazard alert - potential for implanting oversized valves, Information for surgeons and cardiologists, TGA Incident Reporting and Investigation Scheme (IRIS). The physician must exercise medical judgement and consider the patients complete medical history. Contraindications None known. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals.
Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com.
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. 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. 1.5, 3: . This website provides excerpts from our user manuals.
Less information (see less).
Medtronic Neurosurgery Goleta, CA. The Mosaic bioprosthesis based on more than 30 years of Medtronic tissue-valve design expertise is an excellent choice for surgeons looking for long-lasting durability, exceptional performance and implantability for aortic, mitral, and MICS procedures. The 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. Healthcare Professionals
"MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve.
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heart valve Medtronic Inc. Minneapolis, M. 1.5: Safe More. Mosaic Mitral Bioprosthesis Model 310 is not affected. Important Labeling Information for United States.
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. View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel.
Medtronic, Inc. 2018. Warning: Persons allergic to cobalt-chromium . No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. 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.
The Streamline family from Medtronic is designed for post-surgical temporary pacing. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Society for Medical Physics of the Netherlands (NVKF).
This theoretical concern was not born out experimentally, so all-metal valves remain safe to scan at fields at least up to 3T. EpiDiscTM Perforation Patch Kitis 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.
The following postoperative precautionary measures are recommended: Hydroxylapatite is the basic inorganic constituent of living bone tissue. Chole RA and Brummet RE, et al. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were .
The TGA cannot give advice about an individual's medical condition. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. After use, dispose according to applicable national practice. It is possible that some of the products on the other site are not approved in your region or country.
"MR Conditional" Carillon Mitral Contour Device in coronary sinus.
3: Conditional 5 More. Click OK to confirm you are a Healthcare Professional. Treatments & Therapies
Guideline use of MRI in patients with implants.
AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. Indications, Safety, and Warnings.
Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. Cardiovascular The Profile 3D annuloplasty system has a unique asymmetrical 3-D remodeling ring design based on the annular geometry of normal human mitral annuli.
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.
Home 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. 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.
- (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment.
Assists implantation with clear markings for proper orientation. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.
The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. 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. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. Additional factors that may contribute to durability are: The benefits of AOA tissue treatment have been demonstrated through animal testing. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA
Heart Valves .
Your use of the other site is subject to the terms of use and privacy statement on that site. If you continue, you may go to a site run by someone else. View indications, safety, and warnings for the IndigoOtologic Drill.
With an updated browser, you will have a better Medtronic website experience. Update my browser now. A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. AOA Tissue Treatment Video Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures.
Module 1: MRI in patients with a prosthetic heart valve, annuloplasty. 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). *Third-party brands are trademarks of their respective owners. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device.
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. 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.