GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. The Evolut PRO valve features an external tissue wrap added to the proven platform design. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. Home The Evolut PRO valve features an external tissue wrap added to the proven platform design. Heart. 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% 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. 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. Medtronic Canada does not review or control the content on the other website, and is not responsible for any business dealings or transactions you have there. 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 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 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. Download MRI pre-screening forms for patients and MR personnel. Age <60 years Subject Evaluation Damage may result from forceful handling of the catheter. Prior to the procedure, measure the patients creatinine level. Read our disclaimer for details. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Typically devices associated with implantation (e.g., catheter, introducer) are included. 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. 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. Data on file (>20 clinical trials with over 20000 patients enrolled). Medtronic, www.medtronic.com. November 2016;18(11):67. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Access instructions for use and other technical manuals in the Medtronic Manual Library. Healthcare Professionals Prevent kinking of the catheter when removing it from the packaging. 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. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. It provides the lowest delivery profile and added surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI Heart. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. 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. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Avoid freezing. Update my browser now. 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. Prosthesis-patient mismatch: definition, clinical impact, and prevention. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. 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. Evolut PRO+ Anatomical characteristics should be considered when using the valve in this population. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland Access instructions for use and other technical manuals in the Medtronic Manual Library. Find more detailed TAVRinformation, educationalresources, and tools. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook Click OK to confirm you are a Healthcare Professional. 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. Device Dimensions Operating and Storage Conditions Device Identifiers FDA Pre-market Approvals/Notifications & deNovo Premarket Approval: P130021 FDA Product Code NPT Aortic valve, prosthesis, percutaneously delivered Sterilization Device Entry Metadata On-Brand Devices [Evolut PRO+] Trademark Results [Evolut] 2022 FDA.report The external wrap increases surface contact with native anatomy, providing advanced sealing. 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. Less information (see less). Like its predecessor (Evolut PRO+), the newest system includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market. Safety Topics ; Home; help (full/part words) . document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. January 2016;102(2):107-113. 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. It is possible that some of the products on the other site are not approved in your region or country. GO TO THE LIBRARY (opens new window) Aortic transcatheter heart valve bioprosthesis, stent-like framework. Lowest delivery profile 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. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Avoid freezing. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Reproduced with Permission from the GMDN Agency. During the procedure, monitor contrast media usage. November 1, 1999;34(5):1609-1617. Skip to main content English 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. With an updated browser, you will have a better Medtronic website experience. Up to 80% deployment. Evolut PRO. 1.5, 3: Conditional 8 More. Manuals can be viewed using a current version of any major internet browser. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Flameng, W, et al. Your use of the other site is subject to the terms of use and privacy statement on that site. More information (see more) Transcatheter Aortic Heart Valves Home 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. Products Visit: IMRSER Videos. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Products It is possible that some of the products on the other site are not approved in your region or country. Transcatheter Aortic Heart Valves The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. For applicable products, consult instructions for use on manuals.medtronic.com. Reach out to lifeline cardiovascular tech support with questions. If you continue, you will leave this site and go to a site run by someone else. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and has the ability to treat the broadest annulus range* of any commercially available TAVR system. Update my browser now. Search by the product name (e.g., Evolut) or model number. Conduct the procedure under fluoroscopy. Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic DUBLIN, Aug. 24, 2021 /PRNewswire/ --Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Indications, Safety, & Warnings. MRIsafety.com is the premier information resource for magnetic resonance safety. 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. The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. The Evolut PRO system goes beyond the CoreValve and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," said Jeffrey Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. Aortic transcatheter heart valve bioprosthesis, stent-like framework. GMDN Names and Definitions: Copyright GMDN Agency 2015. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. 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. In addition, patient age should be considered as long-term durability of the valve has not been established. for access down to 5.0 mm vessels with the 23-29 mm valves. Evaluate bioprosthesis performance as needed during patient follow-up. Click OK to confirm you are a Healthcare Professional. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM 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. Heart. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. MRIsafety.com is Exclusively Sponsored by BRACCO, MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. 2010; 121:2123-2129. Transcatheter Aortic Heart Valves. 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 Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve 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: Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Broadest annulus range* Excessive contrast media may cause renal failure. 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. Frank.ShellockREMOVE@MRIsafety.com. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Update my browser now. Find additional feature information, educational resources, and tools. Evolut PRO: Reviewing the Journey of self-expanding Transcatheter aortic Valves Cardiol Ther catheter, introducer ) included... Platform design procedure should only be performed promptly from forceful handling of the catheter when removing it the! ):183-192. doi: 10.1007/s40119-017-0100-z platform design continue, you acknowledge that you are a Healthcare Professional manuals the. 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