The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. We are here for you. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. With an updated browser, you will have a better Medtronic website experience. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Medtronic MRI Resource Library Technical Information for Healthcare Professionals. For applicable products, consult instructions for use on manuals.medtronic.com. For applicable products, consult instructions for use on manuals.medtronic.com. 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) The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy 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. 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 . Broadest annulus range based on CT-derived diameters. Selezionare la propria regione. The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 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. These legacy and new design features provide the following sealing mechanisms: The Evolut TAVR platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. 2020 Medtronic. In addition, patient age should be considered as long-term durability of the valve has not been established. 2010; 121:2123-2129. Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. Update my browser now. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. * Third party brands are trademarks of their respective owners. The EnVeo PRO delivery system assists in accurate positioning of the valve. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Reach out to LifeLine CardioVascular Tech Support with questions. For applicable products, consult instructions for use on manuals.medtronic.com. Healthcare Professionals 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. 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. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Home 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. Transcatheter Aortic Valve Replacement (TAVR) Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Bleiziffer S, Eichinger WB, Hettich I, et al. Medtronic MRI Resource Library: Home For best results, use Adobe Acrobat Reader with the browser. Transcatheter Aortic Heart Valves - Evolut R | Medtronic For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. More information (see more) Medtronic, www.medtronic.com If you continue, you may go to a site run by someone else. endstream endobj startxref Less information (see less). After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Evaluate bioprosthesis performance as needed during patient follow-up. Raise your expectations for what is possiblewith the Evolut FX system. Recapture and reposition 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM 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. 2010; 121:2123-2129. Cardiovascular The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. * Third party brands are trademarks of their respective owners. Circulation. 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. MRI Resources | Medtronic Products How long it lasts varies from patient to patient. Allows access down to5.0 mm vessels with2329 mm valves. Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W 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 <4.0m/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.

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