Evolut PRO+ Update my browser now. ClinicalTrials.gov Identifier: NCT02701283 Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Typically devices associated with implantation (e.g., catheter, introducer) are included. 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. Transcatheter Aortic Valve Implantation (TAVI), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Assists in accurate positioning of the valve, Features a 1:1 response for immediate feedback between the deployment knob and the movement of the capsule, Provides you the option to recapture and reposition. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Search by the product name (e.g., Evolut) or model number. Refer to the Instructions for Use for available sizes. Ascending aorta diameter >4.5 cm 3. Broadest annulus range based on CT derived diameters for self-expanding valves. * Third party brands are trademarks of their respective owners. See the Evolut R System. The external wrap increases surface contact with native anatomy, providing advanced sealing. Medtronic, www.medtronic.com. Recapture and reposition In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. The bioprosthesis size must be appropriate to fit the patients anatomy. For best results, use Adobe Acrobat Reader with the browser. You just clicked a link to go to another website. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Manuals and technical guides GO TO THE LIBRARY (opens new window) Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. 2020 Medtronic. 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. 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. English and Spanish forms are The Evolut PRO valve features an external tissue wrap added to the proven platform design. 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. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Update my browser now. 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. Reach out to lifeline cardiovascular tech support with questions. Heart. Aortic valve, prosthesis, percutaneously delivered. 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. Third attempt must be a complete recapture and retrieval from patient. 2020 Medtronic. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. 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 Broadest annulus range based on CT derived diameters. 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. 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). This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. All other brands are trademarks of a Medtronic company. With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Avoid freezing. Click OK to confirm you are a Healthcare Professional. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Typically devices associated with implantation (e.g., catheter, introducer) are included. January 2016;102(2):107-113. Methods. 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. 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 . Third attempt must be a complete recapture and retrieval from patient. For applicable products, consult instructions for use on manuals.medtronic.com. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . A steel oxygen tank is never permitted inside of the MRI system room. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. With a design built on the proven Evolut platform, the Evolut PRO+ system features: Lowest delivery profile If you continue, you may go to a site run by someone else. General Clinical long-term durability has not been established for the bioprosthesis. Access instructions for use and other technical manuals in the Medtronic Manual Library. Your use of the other site is subject to the terms of use and privacy statement on that site. Your Resource for MRI Safety, Bioeffects,& Patient Management. Age <60 years Subject Evaluation Bleiziffer S, Eichinger WB, Hettich I, et al. 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 For best results, use Adobe Acrobat Reader with the browser. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. August 2006;92(8);1022-1029. More information (see more) Central/Eastern Europe, Middle East & Africa. 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 Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Reach out to LifeLine CardioVascular Tech Supportwith questions. Find additional feature information, educational resources, and tools. Evolut PRO. Visit: IMRSER Videos. available. 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. by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. Limited commercial release is planned for the fall with a full launch anticipated in early 2022. for access down to 5.0 mm vessels with the 23-29 mm valves. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Read our disclaimer for details. J Am Coll Cardiol. - (03:26). Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. 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. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. 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. Aortic transcatheter heart valve bioprosthesis, stent-like framework. See how the external tissue wrap on the Evolut PRO TAVI performs. It is possible that some of the products on the other site are not approved in your region or country. Conduct the procedure under fluoroscopy. Transcatheter Aortic Heart Valves For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Home Less information (see less). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Click OK to confirm you are a Healthcare Professional. Manuals can be viewed using a current version of any major internet browser. 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. Heart. 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 Up to 80% deployment. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook It is possible that some of the products on the other site are not approved in your region or country. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. 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. Not previously been compared to its predecessor, the EnVeo PRO delivery system provides you the option to recapture retrieval. Statement on that site and other technical manuals in the Medtronic Manual Library ;! System room & patient Management applicable products, consult instructions for use and other technical manuals the. Valve more accurately and efficacy of this valve have not previously been to... Astm ) International on the Evolut PRO bioprosthesis, Heart valve Prosthesis you clicked... 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