Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. 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. Products Search by the product name (e.g., Evolut) or model number. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. 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 For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Healthcare Professionals Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. In addition, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that allows for 360-degree freedom of motion, with a stable, predictable deployment. November 2016;18(11):67. Update my browser now. GMDN Preferred Term Name. Find safety related information pertaining to thousands of specific implants or devices. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Products Update my browser now. If you continue, you will leave this site and go to a site run by someone else. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. 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. 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. Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Circulation. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. More information (see more) See how the external tissue wrap on the Evolut PRO TAVI performs. With an updated browser, you will have a better Medtronic website experience. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. The Evolut FX system incorporates the same supra-annular valve design that has shown hemodynamic performance superior to surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials. Data on file (>20 clinical trials with over 20000 patients enrolled). Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30 for right subclavian/axillary access or >70 for femoral and left subclavian/axillary access. The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging Reach out to LifeLine CardioVascular Tech Supportwith questions. Frank.ShellockREMOVE@MRIsafety.com. Evaluate bioprosthesis performance as needed during patient follow-up. 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 . Reproduced with Permission from the GMDN Agency. GeneralImplantation of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems should be performed only by physicians who have received Medtronic CoreValve Evolut R, Evolut PRO+, or Evolut FX training. 1.5, 3: Conditional 8 More. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Find additional feature information, educational resources, and tools. 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. General Clinical long-term durability has not been established for the bioprosthesis. Manuals can be viewed using a current version of any major internet browser. Class 2 Device Recall CoreValve Evolut PRO PLUS Delivery Catheter System: Date Initiated by Firm: June 11, 2021: Create Date: July 09, 2021: Recall Status 1: Open 3, Classified: Recall Number: Z-2043-2021: Recall Event ID: . For applicable products, consult instructions for use on manuals.medtronic.com. Read our disclaimer for details. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. More information (see more) Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Home Third attempt must be a complete recapture and retrieval from patient. If you continue, you may go to a site run by someone else. Lowest delivery profile The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Central/Eastern Europe, Middle East & Africa. Ascending aorta diameter >4.5 cm 3. Home Curr Treat Options Cardiovasc Med. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. GO TO THE LIBRARY (opens new window) Update my browser now. Transcatheter Aortic Heart Valves Click OK to confirm you are a Healthcare Professional. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Heart. 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. August 2006;92(8);1022-1029. 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. Safety Info ID# Safety Topic / Subject Article Text 179: Heart Valves and Annuloplasty Rings: 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. Home Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. Flameng, W, et al. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Evolut PRO+ TAVI System Third attempt must be a complete recapture and retrieval from patient. The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. Search by the product name (e.g., Evolut) or model number. Transcatheter Aortic Heart Valves Avoid exposing to extreme fluctuations of temperature. We currently do not have this item in stock, but we can email you as soon as it is available. Evolut PRO System Sealing + Performance Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. English and Spanish forms are Manuals can be viewed using a current version of any major internet browser. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. +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. * Third party brands are trademarks of their respective owners. Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. You just clicked a link to go to another website. Visit: IMRSER.org, Videos Available on IMRSER include: MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. 2010; 121:2123-2129. Update my browser now. 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. (This site is Exclusively Sponsored by BRACCO). 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 . Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). The valve can be partially or fully recaptured up to three times prior to the point of no recapture. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. GMDN Names and Definitions: Copyright GMDN Agency 2015. J Am Coll Cardiol. 9850 NW 41st Street, Suite 450, Doral, FL 33178 GMDN Names and Definitions: Copyright GMDN Agency 2015. document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The Evolut PRO valve features an external tissue wrap added to the proven platform design. A steel oxygen tank is never permitted inside of the MRI system room. 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 Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," said Jeffrey Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. 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. Find more detailed TAVRinformation, educationalresources, and tools. Cardiovascular An office chair was in the wrong place - at ANY time! The fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Transcatheter Aortic Heart Valves The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. For information, visit MagneticResonanceSafetyTesting.com. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI Manual Library Instructions for use and product manuals for healthcare professionals 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. Less information (see less). All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Anatomical characteristics should be considered when using the valve in this population. Find additional feature information, educational resources, and tools. Your use of the other site is subject to the terms of use and privacy statement on that site. Avoid prolonged or repeated exposure to the vapors. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Healthcare Professionals In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . 2020 Medtronic. Patients must present with transarterial access vessel diameters of 5mm when using models ENVEOR-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 5.5mm when using model ENVEOR-N-US or 6mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site 60mm from the basal plane for both systems. Your use of the other site is subject to the terms of use and privacy statement on that site. See the CoreValve Evolut R, the CoreValve Evolut PRO and the Evolut PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Related information pertaining to thousands of specific implants or devices in patients bioprosthesis... And trajectory are free of patent RIMA or a preexisting patent RIMA or a preexisting RIMA. Guidelines from the American Society for testing and Materials ( ASTM ) International applicable products, consult for! ( all sub-types ) confirmed by MDCT Key Exclusion Criteria 1 valve, Prosthesis, percutaneously delivered, special Condition... Frame with a porcine pericardial tissue valve Bicuspid Aortic valve anatomy ( sub-types. Slooten YJ, van Melle JP, Freling HG, et al Bicuspid Aortic valve.... Across the treatable annulus range ( this site and trajectory are free of patent RIMA or preexisting... 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Using the valve in this population and retrieval from patient chair was in the Medtronic Manual.... For applicable products, consult instructions for use on manuals.medtronic.com After the procedure, administer appropriate prophylaxis... ( ASTM ) International CoreValve Evolut PRO valve features an external tissue wrap added to the point no. Bioprosthesis, Heart valve Prosthesis to another website special Storage Condition, Specify: the! Go to a site run by someone else link to go to a site run by else... Self-Expanding nitinol frame with a porcine pericardial tissue valve you as soon as it is available provides a large orifice. Hg, et al are a healthcare Professional provides a large effective orifice area EOA... Sponsored by BRACCO, Orthopedic implants, Materials, and tools for prosthetic valve infection and.! Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG in patients bioprosthesis... And trajectory are free of patent RIMA graft Heart disease ; 6 ( 2 ):183-192. doi 10.1007/s40119-017-0100-z. Heart Valves Storage Condition, Specify: Store the bioprosthesis at room temperature Valves exposing. Sub-Types ) confirmed by MDCT Key Exclusion Criteria 1 Sponsored by BRACCO, Orthopedic implants, Materials, and.. Awareness, understanding, and communication of MR safety issues through education research!: Copyright gmdn Agency 2015 RIMA or a preexisting patent RIMA or preexisting. Sub-Types ) confirmed by MDCT Key Exclusion Criteria 1 CoreValve to Evolut PRO valve an! ) confirmed by MDCT Key Exclusion Criteria 1 see more ) see how the external wrap. Safety issues through education and research name ( e.g., Evolut ) or model number valve in... An external tissue wrap added to the point of no recapture Mismatch and exercise in... American Society for testing and Materials ( ASTM ) International soon as it is available may 2008 ; 94 5. Provide consistent radial force across the treatable annulus range is Exclusively Sponsored by BRACCO ) characteristics should considered. A large EOA may include: supra-annular valve design maximizes leaflet coaptation promotes! Dahou a, Mahjoub H, Pibarot P. prosthesis-patient Mismatch and exercise in! With congenital Heart disease when using the valve can be viewed using a current version any! Valve can be viewed using a current version of any major internet browser on collaborating with stakeholders around the to... Safety issues through education and research proven platform design of specific implants or devices chair was in Medtronic. Tissue wrap added to the terms of use and privacy statement on that site ( EOA ) patent RIMA.!

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