The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. 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 Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. 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. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. 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. - (03:31), View this video for more information on the Medtronic alpha-aminooleic acid (AOA) tissue treatment. Published clinical experience demonstrates impressive long-term performance in all age groups. Heart Valves Surgical. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Mosaic 29 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.*. Valve dimensions and geometry facilitate future ViV procedures. If using an MRI device, see the MRI technical manual . 1.5: Safe More . 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. This site is Exclusively Sponsored by BRACCO. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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. Products Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 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 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. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. Product names on this page are trademarks or registered trademarks of Medtronic. To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. 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). Treatments & Therapies Aortic and Mitral Valve Replacement No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. Update my browser now. "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. Less information (see less). 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.
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