Click OK to confirm you are a Healthcare Professional. Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Reach out to LifeLine CardioVascular Tech Support with questions. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. * Third party brands are trademarks of their respective owners. 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 < 17 mm. 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. More information (see more) Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Manuals can be viewed using a current version of any major internet browser. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. The safety and efficacy of Medtronic's CoreValve system has been evaluated in more than a dozen clinical trials, including Medtronic's CoreValve U.S. Pivotal Trial (1,389 subjects followed for five years) and the SURTAVI trial (1,660 subjects followed for two years with a plan for ten-year follow-up). November 1, 1999;34(5):1609-1617. Heart Valves and Annuloplasty Rings More. Cardiovascular Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve Evolut PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR). * Third party brands are trademarks of their respective owners. Transcatheter Aortic Heart Valves - Evolut R | Medtronic Click OK to confirm you are a Healthcare Professional. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Broadest annulus range based on CT-derived diameters. 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). Home Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Update my browser now. 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. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Patients who do not are more likely to have a stroke. Transcatheter Aortic Heart Valves TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 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. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. The bioprosthesis size must be appropriate to fit the patients anatomy. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Update my browser now. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and hasthe ability to treat the broadest annulus range* of any commercially available TAVR system. Or, you may contact technical support online. Antibiotics maybe recommendedfor patients who are at risk of infections. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Home 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. With an updated browser, you will have a better Medtronic website experience. $G` Object Info: - MRI Safety The EnVeo PRO delivery system assists in accurate positioning of the valve. Go . cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX Less information (see less). Recapture and reposition Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). Healthcare Professionals - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Conduct the procedure under fluoroscopy. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. Healthcare Professionals Cardiovascular hb```lu eah(x B 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. Epub 2017 Oct 27. Home Keep appointments with your doctor. Your use of the other site is subject to the terms of use and privacy statement on that site. Lowest delivery profile How long it lasts varies from patient to patient. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. It is possible that some of the products on the other site are not approved in your region or country. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. 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. Pibarot P, Dumesnil JG. Access instructions for use and other technical manuals in the Medtronic Manual Library. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Update my browser now. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS At some point, the Medtronic TAVR valve may need tobe replaced. Select country / region and language . Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. 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. Cardiovascular Healthcare Professionals Curr Treat Options Cardiovasc Med. Evaluate bioprosthesis performance as needed during patient follow-up. Manuals can be viewed using a current version of any major internet browser. Medtronic MRI Resource Library: Region Evolut FX - Transcatheter Aortic Heart Valves | Medtronic The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. Object Info: - MRI Safety Selezionare la propria regione. PRODUCT DETAILS EXCEPTIONAL DESIGN T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s Reach out to LifeLine CardioVascular Tech Supportwith questions. 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, 8.8% 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 . All other brands are trademarks of a Medtronic company. Bench testing may not be indicative of clinical performance. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Transcatheter aortic valve replacement (TAVR), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Cardiogenic shock failure of the heart topump enough blood to the body organs, Cardiac tamponade the constriction orinability of the heart to pump due to buildup ofblood or fluidaround the lining of the heart, Perforation of the myocardium or vessel ahole in the heart muscle or a blood vessel, Partial or complete block of coronary artery(that supplies blood to the heart), Ascending aorta trauma injury to the largeblood vessel leading blood away from the heart, Additional cardiac surgery, vascular surgery, orintervention, including removal of the TAV. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. With an updated browser, you will have a better Medtronic website experience. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. Up to 80% deployment. With an updated browser, you will have a better Medtronic website experience. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. per pulse sequence) in 1.5-Tesla and 3-Tesla MR systems, using an MR system reported, whole body averaged SAR of 2-W/kg or less, as follows: Highest temperature changes Transcatheter Aortic Heart Valves SPECIFICATIONS Evolut PRO+ TAV R BIOPROSTHESIS Evolut PRO+ 23 mm Valve Evolut PRO+ 26 mm Valve Model Number: EVPROPLUS-23US Size: 23 mm Aortic annulus diameter: 17*/18-20 mm Model Number: EVPROPLUS-26US Size: 26 mm Aortic annulus diameter: 20-23 mm LOADING SYSTEM Evolut PRO+ Loading System Model Number: L-EVPROP2329US Find additional feature information, educational resources, and tools. Transcatheter Aortic Valve Replacement (TAVR) Indications, Safety, and Warnings - Evolut FX | Medtronic THE List - MRI Safety Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR), 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. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. You may also call 800-961-9055for a copy of a manual. Cardiovascular Access instructions for use and other technical manuals in the Medtronic Manual Library. August 2006;92(8);1022-1029. Flameng, W, et al. The external wrap increases surface contact with native anatomy, providing advanced sealing. Broadest annulus range* Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: . Veuillez slectionner votre rgion. Indications, Safety, & Warnings. Safety Topic / Subject Heart Valves and Annuloplasty Rings. MRI Resources | Medtronic United States of America * Country / Region. %%EOF 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. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. Smooth, controlled, precise, and predictable. Excessive contrast media may cause renal failure. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Object Status: Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Manuals and technical guides More information (see more) The Evolut PRO valve features an external tissue wrap added to the proven platform design. October 14, 2020 Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). General surgical risks applicable to transcatheter aortic valve implantation: abnormal lab values (including electrolyte imbalance, allergic reaction to antiplatelet agents, contrast medium, or anesthesia, exposure to radiation through fluoroscopy and angiography. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Evolut PRO+. You may also call800-961-9055 for a copy of a manual. This study is a prospective, single arm, multi-center . You just clicked a link to go to another website. 3: Conditional 5 More. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. $/R$J101 Safety Info ID# Safety Topic / Subject Article Text 179: . All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Less information (see less). Skip to main content English The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. Treatments & Therapies 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
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