Heart Valves Surgical For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Object Category Heart Valves and Annuloplasty Rings. Product names on this page are trademarks or registered trademarks of Medtronic. With an updated browser, you will have a better Medtronic website experience. 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. Products Diagram of "MR Conditional" mitral valve annuloplasty ring sutured into place. Your cardiac surgery destination for education, evidence, and innovation. Heart Valves and Annuloplasty Rings More. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Product details Undeniably durable Less information (see less). Safety Info ID# Safety Topic / Subject Article Text 179: . THE List - MRI Safety Home With an updated browser, you will have a better Medtronic website experience. All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. 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. 3: Conditional 5 More. 1.5, 3: . The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." Mosaic and Mosaic Ultra Bioprostheses. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. 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 Mosaicbioprosthesis (MB) (Medtronic, Inc.; Minneapolis, Minn) is a 3rd-generation porcine valve that became clinically available in 1994. 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. The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. After use, dispose according to applicable national practice. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Update my browser now. 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). *Third-party brands are trademarks of their respective owners. This problem has occurred at a rate of 0.33% (3.3 reports per 1000 aortic valves). View indications, safety, and warnings for the IPCSystem (lntegrated Power Console). CVG EMEA Indications, Safety and Warnings | Medtronic Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. It is possible that these complications could lead to reoperation, explantation, permanent disability, and death. 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. Heart Valves Surgical. 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. With an updated browser, you will have a better Medtronic website experience. Heart Valves - Surgical | Medtronic Design is based on CT data from functional human tricuspid valves. MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. Assists implantation with clear markings for proper orientation. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. 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. 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.*. Home Mosaic & Mosaic Ultra Bioprostheses Ann Thorac Surg. PDF Guidelines for Managing Patients with Heart Valve Prostheses - ISMRM Medtronic Manuals: Region If you continue, you may go to a site run by someone else. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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). Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. View indications, safety, and warnings for the IndigoOtologic Drill. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. A subset of these valves have required explantation within five years of implantation at an overall occurrence rate of 0.1% (one explant per 1000 aortic implants). On-X Aortic Heart Valve - Artivion 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%). Instructions for Use. 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. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Note green deployment catheter. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Avoid packing external ear canal with adherent dressings or applying excessive pressure. 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 Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). 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. 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. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. Even very old stainless steel valves are likewise considered of no danger in MRI. 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). A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Technical Support. Healthcare Professionals Medtronic, Inc. 2018. 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. 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 Mosaic and Mosaic Ultra Bioprostheses - Surgical Heart Valves - Medtronic 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. 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. Download Brochure (opens new window) Product Details Undeniably Durable Heart Valves and Annuloplasty Rings More. EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. Update my browser now. It is possible that some of the products on the other site are not approved in your region or country. PMA Monthly approvals from 2/1/2022 to 2/28/2022 Original Total: 1 Supplements Total: 68 30-Day Notice P200030/S007 02/22/2022 X - 30-Day Notice GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS (CEXC). Guideline use of MRI in patients with implants. View indications, safety, and warnings for the NIMNerve Integrity Monitoring Systems. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain. Products Cardiovascular No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted.

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