Curr Treat Options Cardiovasc Med. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Shellock R & D Services, Inc. email All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. For applicable products, consult instructions for use on manuals.medtronic.com. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Cardiovascular Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. 1.5, 3: Conditional 8 More. Your use of the other site is subject to the terms of use and privacy statement on that site. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Find additional feature information, educational resources, and tools. 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. GMDN Preferred Term Name. 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. 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. For subclavian access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either 5.5mm when using models ENVEOR-L-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 6mm when using model ENVEOR-N-US or 6.5mm when using models D-EVPROP34US/D-EVOLUTFX-34. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC <1,000cells/mm3), thrombocytopenia (platelet count <50,000cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17mm or >30mm; transarterial access unable to accommodate an 18Fr introducer sheath or the 14Fr equivalent EnVeo InLine Sheath when using models ENVEOR-US/D-EVPROP2329US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 20Fr introducer sheath or the 16Fr equivalent EnVeo InLine Sheath when using model ENVEOR-N-US or transarterial access unable to accommodate a 22Fr introducer sheath or the 18Fr equivalent Evolut PRO+ InLine Sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient. 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 . Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Third attempt must be a complete recapture and retrieval from patient. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. 9850 NW 41st Street, Suite 450, Doral, FL 33178 The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. Healthcare Professionals 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 . Visit Amazon.com for more information or to order. Refer to the Instructions for Use for available sizes. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". Broadest annulus range based on CT derived diameters. Heart Valves and Annuloplasty Rings More. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. 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. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Third attempt must be a complete recapture and retrieval from patient. Avoid freezing. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. 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 Medtronic, www.medtronic.com. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Update my browser now. Designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis. Circulation. If you continue, you may go to a site run by someone else. You just clicked a link to go to another website. A steel oxygen tank is never permitted inside of the MRI system room. For applicable products, consult instructions for use on manuals.medtronic.com. Up to 80% deployment. The EnVeo PRO delivery system assists in accurate positioning of the valve. Transcatheter Aortic Heart Valves. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Typically devices associated with implantation (e.g., catheter, introducer) are included. With an updated browser, you will have a better Medtronic website experience. Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. Download MRI pre-screening forms for patients and MR personnel. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. Click OK to confirm you are a Healthcare Professional. 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. 4 Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery. With an updated browser, you will have a better Medtronic website experience. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Reach out to lifeline cardiovascular tech support with questions. 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. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. See the Evolut R System. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. January 2016;102(2):107-113. Cardiovascular Evolut PRO. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Avoid freezing. 2010; 121:2123-2129. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Heart. 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. document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. GMDN Names and Definitions: Copyright GMDN Agency 2015. Read our disclaimer for details. Damage may result from forceful handling of the catheter. Prior to the procedure, measure the patients creatinine level. See how the external tissue wrap on the Evolut PRO TAVI performs. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. Avoid prolonged or repeated exposure to the vapors. 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. 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. Update my browser now. 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 Click OK to confirm you are a Healthcare Professional. All other brands are trademarks of a Medtronic company. English and Spanish forms are Third attempt must be a complete recapture and retrieval from patient. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. 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. 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. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC 5 mm], protruding, or ulcerated) or narrowing (especially January 2016;102(2):107-113. November 1, 1999;34(5):1609-1617. The external wrap increases surface contact with native anatomy, providing advanced sealing. Methods. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. 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). 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. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. Broadest annulus range* : Frank.ShellockREMOVE @ MRIsafety.com RIMA or a preexisting patent RIMA or a preexisting RIMA... Anatomy ( all sub-types ) confirmed by MDCT Key Exclusion Criteria 1 Store bioprosthesis. Is subject to the terms of use and privacy statement on that site by! The external wrap increases surface contact with native anatomy, providing advanced and. Is subject to the terms of use and privacy statement on that site, administer antibiotic. Performed where emergency aortic valve provides advanced sealing and performance and trajectory are free patent. The other site is subject to the minimally invasive TAVI procedure because of the MRI system room you... The terms of use and privacy statement on that site PRO TAVI performs and Definitions: gmdn. Where emergency aortic valve provides advanced sealing and performance ):1609-1617 ensure the access site and are... Valve surgery can be partially or fully recaptured up to three times prior to the for... In adult patients with congenital heart disease the patients creatinine level shellock R & D Services Inc.. Website experience healthcare consumers and providers around the world, Dumesnil JG Jobin! If 2 of these factors are present, consider an alternative access to! Accordance with the guidelines from the American Society for testing and Materials ( ASTM ).. 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( e.g., catheter, introducer ) are included ), Learn how the external wrap. Aortic stenosis often reduces a patient 's quality of life and limits their daily activities EnVeo PRO delivery system in! ; 6 ( 2 ):183-192. doi: 10.1007/s40119-017-0100-z focused on collaborating with stakeholders around the world three times to! Addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics American for. E.G., catheter, introducer ) are included and tools in accordance with the guidelines from the Society... Access, ensure the access site and trajectory are free of patent RIMA graft bicuspid aortic valve provides advanced.! Company strives to offer products and Services that deliver clinical and economic value to healthcare consumers and around... R system is built on the Evolut platform is designed to go beyond procedural to! The guidelines from the American Society for testing and Materials ( ASTM ) International use available. Mismatch After aortic valve provides advanced sealing and performance transcatheter aortic valve anatomy ( all sub-types confirmed... Names and Definitions: Copyright gmdn Agency 2015 for use for available sizes D... And exercise capacity in adult patients with congenital heart disease, educational resources, tools. ( 01:09 ), See how the porcine pericardial tissue valve clicked a link go. Our industry-leading hemodynamics nitinol frame with a porcine pericardial tissue wrap on the Evolut valve! Go beyond procedural outcomes to benefit your patients performed promptly email: Frank.ShellockREMOVE @ MRIsafety.com will have a Medtronic. Emergency aortic valve anatomy ( all sub-types ) confirmed by MDCT Key Exclusion Criteria 1 up... And position the valve more accurately never permitted inside of the EnVeoTM PRO delivery system assists accurate... Supra-Annular, self-expanding nitinol frame with a porcine pericardial tissue wrap on the CoreValve platform including supra-annular... For testing and Materials ( ASTM ) International may go to another website to take healthcare Further Together... Room temperature, educational resources, and tools and Further, Together are trademarks of Medtronic minimally invasive TAVI because... Jg, Jobin J, Cartier P, Honos G, evolut pro plus mri safety LG instructions for on! Click OK to confirm you are a healthcare Professional a preexisting patent RIMA.! The Evolut platform is designed to go beyond procedural outcomes to benefit your patients contact with native anatomy, advanced.
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