medtronic evolut pro valve mri safety

Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Recapture and reposition J Am Coll Cardiol. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. It is possible that some of the products on the other site are not approved in your region or country. Curr Treat Options Cardiovasc Med. Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve Evolut PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR). 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. For best results, use Adobe Acrobat Reader with the browser. Healthcare Professionals Less information (see less). Fewer instances of prosthesis-patient mismatch (PPM), which has been correlated to improved long-term survival, A large EOA provides improved flow, less resistance, and better long-term durability. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Click OK to confirm you are a Healthcare Professional. Curr Treat Options Cardiovasc Med. Heart. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. THE List - MRI Safety The Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap on all valve sizes. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Bitte whlen Sie Ihre Region. See how the external tissue wrap on the Evolut PRO TAVI performs. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. For applicable products, consult instructions for use on manuals.medtronic.com. We are here for you. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Cardiovascular Important Safety Information. Smooth, controlled, precise, and predictable. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO device is Medtronic CoreValve Evolut PRO System, and the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System. Reach out to LifeLine CardioVascular Tech Support with questions. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. The EnVeo PRO delivery system assists in accurate positioning of the valve. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. January 2016;102(2):107-113. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Medtronic MRI Resource Library: Region With an updated browser, you will have a better Medtronic website experience. Proper sizing of the devices is the responsibility of the physician. Patients The Evolut R valve was built on the proven design of our CoreValve platform and features a supra-annular, self-expanding nitinol frame with a low delivery profile. Important Safety Information - Transcatheter Aortic Valve Replacement (TAVR) | Medtronic Your browser is out of date With an updated browser, you will have a better Medtronic website experience. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. Prevent kinking of the catheter when removing it from the packaging. You just clicked a link to go to another website. 2010; 121:2123-2129. With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. Healthcare Professionals For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. General surgical risks applicable to transcatheter aortic valve implantation: abnormal lab values (including electrolyte imbalance, allergic reaction to antiplatelet agents, contrast medium, or anesthesia, exposure to radiation through fluoroscopy and angiography. Conduct the procedure under fluoroscopy. United States of America * Country / Region. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. All other brands are trademarks of a Medtronic company. All other brands are trademarks of a Medtronic company. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. %PDF-1.5 % Safety Topic / Subject Heart Valves and Annuloplasty Rings. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. It is possible that some of the products on the other site are not approved in your region or country. Search by the product name (e.g., Evolut) or model number. Bleiziffer S, Eichinger WB, Hettich I, et al. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. November 2016;18(11):67. performance of the Evolut platform over time. Cardiovascular The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Meet the Evolut R System. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. How long it lasts varies from patient to patient. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. 2023 Medtronic . Heart Valves and Annuloplasty Rings More. Patients who do not are more likely to have a stroke. August 2006;92(8);1022-1029. Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic PDF PRO TAVR SPECIFICATIONS - asiapac.medtronic.com * Third party brands are trademarks of their respective owners. See the Evolut R System. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. Potential risks associated with the implantation of the CoreValve Evolut R, Evolut PRO+, or Evolut FX transcatheter aortic valve may include, but are not limited to, the following: Please reference the CoreValve Evolut R, Evolut PRO+, and Evolut FX Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events. Products Click OK to confirm you are a Healthcare Professional. Home Products More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Evolut FX. The Evolut PRO valve features an external tissue wrap added to the proven platform design. October 14, 2020 Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). EVPROPLUS-29US: Medtronic Evolut Pro+ Transcatheter Aortic Valve 29mm Or, you may contact technical support online. PDF Summary of Safety and Effectiveness Data I. General Information Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Home More information (see more) Brand Name: Evolut PRO+ Version or Model: EVPROPLUS-29US Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC COREVALVE LLC Primary DI Number: 00763000211127 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527231 * Terms of Use cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic CoreValve Evolut Pro and Pro . Transcatheter Aortic Valve Replacement (TAVR) Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. Transcatheter Aortic Heart Valves | Medtronic Reach out to LifeLine CardioVascular Tech Supportwith questions. The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus.

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