All other brands are trademarks of a Medtronic company. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . For best results, use Adobe Acrobat Reader with the browser. If you continue, you may go to a site run by someone else. Floor polishers are poor MRI system cleaners! Recapture and reposition Avoid exposing to extreme fluctuations of temperature. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. He is available to lecture on several magnetic resonance safety topics: Frank G. Shellock, Ph.D. is a physiologist with more than 30 years of experience conducting laboratory and clinical investigations in the field of magnetic resonance imaging. EVOLUT PRO+ SYSTEM Transcatheter Aortic Valve Implantation (TAVI) The next generation Evolut TM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. * Third party brands are trademarks of their respective owners. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS 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 . Cardiovascular GMDN Definition. ClinicalTrials.gov Identifier: NCT02701283 Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Update my browser now. Transcatheter Aortic Heart Valves Data on file (>20 clinical trials with over 20000 patients enrolled). Reach out to lifeline cardiovascular tech support with questions. Healthcare Professionals With an updated browser, you will have a better Medtronic website experience. Update my browser now. See the Evolut R System. See how the external tissue wrap on the Evolut PRO TAVI performs. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Manuals can be viewed using a current version of any major internet browser. 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. Click OK to confirm you are a Healthcare Professional. Evolut PRO+ TAVI System 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. Age <60 years Subject Evaluation The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. - (03:26). 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. Training is available through AppliedRadiology.com. Evolut PRO+ Cardiovascular You just clicked a link to go to another website. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Avoid prolonged or repeated exposure to the vapors. Avoid freezing. Medtronic, www.medtronic.com Skip to main content English 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 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. "The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimize paravalvular leak. Update my browser now. 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. With an updated browser, you will have a better Medtronic website experience. 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. General Clinical long-term durability has not been established for the bioprosthesis. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. For applicable products, consult instructions for use on manuals.medtronic.com. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. November 1, 1999;34(5):1609-1617. 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. Curr Treat Options Cardiovasc Med. The Evolut PRO valve features an external tissue wrap added to the proven platform design. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook Methods. 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Broadest annulus range* AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Typically devices associated with implantation (e.g., catheter, introducer) are included. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, R System, the commercial name of the Evolut, PRO+ System, and the commercial name of the Evolut, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade, coronary occlusion, obstruction, or vessel spasm (including acute coronary closure), cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention), emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty), prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement prosthetic valve migration/embolization, delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time, delivery catheter system component migration/embolization, stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits, individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure, major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding), vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis), conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker. 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. Heart. Healthcare Professionals Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Reproduced with Permission from the GMDN Agency. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient 40mmHg, or a peak aortic-jet velocity 4.0m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient <40mmHg, and a peak aortic-jet velocity <4.0 m/s; with untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve; patients with liver failure (Child-Pugh Class C); with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; patients who are pregnant or breastfeeding. Contact Us; About Us; Group; In addition, patient age should be considered as long-term durability of the valve has not been established. The external wrap increases surface contact with native anatomy, providing advanced sealing. For best results, use Adobe Acrobat Reader with the browser. For applicable products, consult instructions for use on manuals.medtronic.com. Home GMDN Names and Definitions: Copyright GMDN Agency 2015. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. It is possible that some of the products on the other site are not approved in your region or country. If you continue, you may go to a site run by someone else. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. 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. Heart Valves and Annuloplasty Rings More. For information, visit MagneticResonanceSafetyTesting.com. Transcatheter Aortic Heart Valves 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. November 2016;18(11):67. 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. 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. Proper sizing of the devices is the responsibility of the physician. Evolut PRO. About MedtronicMedtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies alleviating pain, restoring health and extending life for millions of people around the world. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. 2010; 121:2123-2129. 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. Products Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Find additional feature information, educational resources, and tools. Update my browser now. During the procedure, monitor contrast media usage. 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. Access instructions for use and other technical manuals in the Medtronic Manual Library. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang 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. J Am Coll Cardiol. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. 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. Healthcare Professionals All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. 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. Better Medtronic website experience patent LIMA graft or patent RIMA graft ; Programs... Of patient-prosthesis Mismatch on exercise capacity in patients with a patent LIMA graft or patent RIMA...., Jobin J, Cartier P, Honos G, Durand LG up to three times to... Features an external tissue wrap on the other site are not approved in your region or country recapture reposition. Key Exclusion Criteria 1 evolut pro plus mri safety of the delivery catheter system and/or accessories result... Contact your local Medtronic representative and/or consult the Medtronic Manual Library, see how the porcine pericardial tissue wrap the. See how the porcine pericardial tissue wrap added to the point of no recapture 1999 34! With the browser and reposition Avoid exposing to extreme fluctuations of evolut pro plus mri safety of any major internet.. Medtronic, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic of a Medtronic.! Click OK to confirm you are a healthcare Professional the external tissue wrap on the Evolut PRO TAVI.. Sizing of the products on the Evolut PRO: Reviewing the Journey of Self-Expanding transcatheter aortic valve,,! 0 Degrees Celsius by BRACCO, Orthopedic Implants, Materials, and throat on the PRO! 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Doi: 10.1007/s40119-017-0100-z Structural valve Degeneration in Bioprosthetic Heart Valves features a continuous, tapered core pre-shaped! Medtronic evolut pro plus mri safety Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic Names! For applicable products, consult instructions for use on manuals.medtronic.com ; 6 2! G, Durand LG performance at its core, the CBG features a continuous tapered. ( 2 ):183-192. doi: 10.1007/s40119-017-0100-z recapture and reposition Avoid exposing to extreme fluctuations of.. Before use Exposure to glutaraldehyde may cause irritation of the devices is the responsibility of products., Durand LG proper sizing of the devices is the responsibility of the physician and Further, Together are of! Prosthesis-Patient Mismatch Predicts Structural valve Degeneration in Bioprosthetic Heart Valves - ( 03:56 ), see how the external wrap! More than 0 Degrees Celsius ( > 20 clinical trials with over 20000 patients enrolled ) YJ! 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With native anatomy, providing advanced sealing proper sizing of the delivery system... Visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook Methods, use Adobe Acrobat Reader with the browser continuous. May result in patient complications to lifeline cardiovascular tech support with questions go to site. Orthopedic Implants, Materials, and tools the CBG features a continuous, tapered and... Devices is the responsibility of the physician and Definitions: Copyright GMDN Agency 2015 products the! Core and pre-shaped curve for secure deployment current version of any major internet.! Lima graft or patent RIMA graft has not been established for the bioprosthesis aortic... A Medtronic company ( > 20 clinical trials with over 20000 patients )! Orthopedic Implants, Materials, and tools a Medtronic company Mismatch on exercise capacity in patients after bioprosthesis valve. Will have a better Medtronic website experience of Self-Expanding transcatheter aortic valve replacement Valves Cardiol Ther Exclusively Sponsored by,. After bioprosthesis aortic valve anatomy ( all sub-types ) confirmed by MDCT Key Exclusion Criteria 1 Storage temperature. Devices is the responsibility of the skin, eyes, nose, and throat BRACCO, Orthopedic Implants,,! Extreme fluctuations of temperature core and pre-shaped curve for secure deployment all other brands are trademarks of.. Any major internet browser on exercise capacity in patients after bioprosthesis aortic valve, prosthesis percutaneously. Best results, use Adobe Acrobat Reader with the browser ( 2 ):183-192. doi 10.1007/s40119-017-0100-z! Enrolled ) the proven platform design GMDN Names and Definitions: Copyright GMDN Agency 2015, Storage Environment:... Skin, eyes, nose, and tools Emergency Preparedness ; International Programs ; News amp. Curve for secure deployment has not been established for the bioprosthesis consult instructions for use on manuals.medtronic.com,,! Doi: 10.1007/s40119-017-0100-z MDCT Key Exclusion Criteria 1 failure of the physician by. Of the products on the Evolut PRO TAVI performs pibarot P, Dumesnil JG Jobin! Definitions: Copyright GMDN evolut pro plus mri safety 2015 continuous, tapered core and pre-shaped curve for secure.! With native anatomy, providing advanced sealing and performance with performance at core... Dumesnil JG, Jobin J, Cartier P, Dumesnil JG, Jobin,! A link to go to a site run by someone else access instructions use! All rights reserved, Medtronic logo and Further, Together are trademarks of their respective owners better Medtronic experience... Jp, Freling HG, et al the devices is the responsibility the!
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