The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Less information (see less). This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. English and Spanish forms are Medtronic, www.medtronic.com. Additional Details Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US Size: 29mm Aortic Annulus Diameter: 23-26mm For Use With Loading System: L-EVPROP2329US Delivery Catheter System: D-EVPROP2329US Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis, CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI, CORFLO UltraNon-weightedFeeding TubeStylet RemovedPolyurethangeViasys Healthcard SystemsWheeling, IL, CORFLO, ULTRA 7Enteral Feeding TubeViasys MedSystemsWheeling, IL, Corkscrew Suture Anchor, PEEK Arthrex, www.arthrex.com, Corkscrew Suture Anchor, Titanium, Stainless Steel Arthrex, www.arthrex.com, CorMARK, Biopsy MarkerHologic, www.hologic.com, CorMarkTissue Marker14 gaugeEthicon EndosurgeryCincinnati, OH, CORNERSTONE PSR ImplantMedtronic, Inc., www.medtronic.com- Please refer to the labeling documents available at www.medtronic.com/mri, Coroflex ISAR NEO Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Coroflex ISAR Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Corograft Arterial Graft L-HydroLabcor Laboratorios Ltda., www.labcor.com, CORolla TAA DeviceCorAssist Cardiovascular Ltd., www.corassist.com, Coronary Vein MarkerMed-Edge, Inc., www.med-edge.info, Cortical bone screw4.5 x 36 mm (titanium alloy)orthopedic implantDePuy ACE Medical Co.El Segundo, CA, Cortical bone screwlarge (titanium alloy)orthopedic implantZimmerWarsaw, I, Cortical bone screwsmall (titanium alloy)orthopedic implantZimmerWarsaw, I, corVCD (implant for vessel coupling)corLife GBR, www.corlife.eu, Corvita EndoluminalGraft for AbdominalAortic Aneurysm27 x 120coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Cosgrove-Edwards Annuloplasty RingModel 4600, heart valveBaxter Healthcare CorporationISanta Ana, CA. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Contact Us; About Us; Group; It is possible that some of the products on the other sitenot be licensed for sale in Canada. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Manuals can be viewed using a current version of any major internet browser. Data on file (>20 clinical trials with over 20000 patients enrolled). It is possible that some of the products on the other site are not approved in your region or country. +1 (305) 500-9328, Evolut FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. Skip to main content English GMDN Definition. Evolut PRO+ Transcatheter Aortic Valve, The next generation EvolutTM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster.1,2,3, Evolut PRO+ TAVI System 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. The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. Limited commercial release is planned for the fall with a full launch anticipated in early 2022. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Avoid exposing to extreme fluctuations of temperature. A steel oxygen tank is never permitted inside of the MRI system room. Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. 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. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. It is possible that some of the products on the other site are not approved in your region or country. The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. 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. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (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: If you continue, you may go to a site run by someone else. MRIsafety.com is Exclusively Sponsored by BRACCO, MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Actual results may differ materially from anticipated results. Less information (see less). 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. Home MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Curr Treat Options Cardiovasc Med. Epub 2017 Oct 27. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Click OK to confirm you are a Healthcare Professional. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. 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. Download MRI pre-screening forms for patients and MR personnel. Your use of the other site is subject to the terms of use and privacy statement on that site. From a design built on a proven platform1, the EVOLUT PRO+ system provides the performance and outcomes you need to help patients live life to the fullest. The safety and effectiveness of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a failed preexisting transcatheter bioprosthesis have not been demonstrated. Implanting a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis in a degenerated surgical bioprosthetic valve (transcatheter aortic valve in surgical aortic valve [TAV-in-SAV]) should be avoided in the following conditions: The degenerated surgical bioprosthetic valve presents with: a significant concomitant paravalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g., wire form frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer-labeled inner diameter <17mm. 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. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Medtronic, www.medtronic.com Aortic transcatheter heart valve bioprosthesis, stent-like framework. The Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and has the ability to treat the broadest annulus range* of any commercially available TAVR system. The Evolut PRO valve features an external tissue wrap added to the proven platform design. You just clicked a link to go to another website. For applicable products, consult instructions for use on manuals.medtronic.com. Heart. GMDN Preferred Term Name GMDN Definition; Aortic transcatheter heart valve bioprosthesis, stent-like framework An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral . 2020 Medtronic. Your Resource for MRI Safety, Bioeffects,& Patient Management. August 2006;92(8);1022-1029. Medtronic Canada does not review or control the content on the other website, and is not responsible for any business dealings or transactions you have there. 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. Update my browser now. Transcatheter Aortic Heart Valves Healthcare Professionals J Am Coll Cardiol. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Reproduced with Permission from the GMDN Agency. Conduct the procedure under fluoroscopy. Cardiovascular These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years. Avoid prolonged or repeated exposure to the vapors. More information (see more) Prosthesis-patient mismatch: definition, clinical impact, and prevention. 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. General Clinical long-term durability has not been established for the bioprosthesis. Reach out to lifeline cardiovascular tech support with questions. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. * Third party brands are trademarks of their respective owners. Avoid freezing. Broadest annulus range based on CT derived diameters for self-expanding valves. January 2016;102(2):107-113. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. Manual Library Instructions for use and product manuals for healthcare professionals If you continue, you may go to a site run by someone else. 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