Evolut PRO. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Find additional feature information, educational resources, and tools. Products * Third party brands are trademarks of their respective owners. Anatomical characteristics should be considered when using the valve in this population. Download MRI pre-screening forms for patients and MR personnel. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). An office chair was in the wrong place - at ANY time! During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. For information, visit MagneticResonanceSafetyTesting.com. If you continue, you will leave this site and go to a site run by someone else. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Evolut PRO System Sealing + Performance Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Healthcare Professionals * Third party brands are trademarks of their respective owners. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience General Clinical long-term durability has not been established for the bioprosthesis. Broadest annulus range based on CT derived diameters. "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. Shellock R & D Services, Inc. email Broadest annulus range based on CT derived diameters. 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. As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. 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. 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. Evolut PRO+ Floor polishers are poor MRI system cleaners! All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. +353 (0)1 4047 113 info@evolut.ie. For best results, use Adobe Acrobat Reader with the browser. Manuals and technical guides Transcatheter Aortic Heart Valves The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. 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. 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. You just clicked a link to go to another website. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 4 Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery. See how the external tissue wrap on the Evolut PRO TAVI performs. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Your use of the other site is subject to the terms of use and privacy statement on that site. Data on file (>20 clinical trials with over 20000 patients enrolled). November 1, 1999;34(5):1609-1617. The EnVeo PRO delivery system assists in accurate positioning of the valve. January 2016;102(2):107-113. 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. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. Find safety related information pertaining to thousands of specific implants or devices. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Prevent kinking of the catheter when removing it from the packaging. 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. Less information (see less). With an updated browser, you will have a better Medtronic website experience. Typically devices associated with implantation (e.g., catheter, introducer) are included. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC <1,000cells/mm3), thrombocytopenia (platelet count <50,000cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17mm or >30mm; transarterial access unable to accommodate an 18Fr introducer sheath or the 14Fr equivalent EnVeo InLine Sheath when using models ENVEOR-US/D-EVPROP2329US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 20Fr introducer sheath or the 16Fr equivalent EnVeo InLine Sheath when using model ENVEOR-N-US or transarterial access unable to accommodate a 22Fr introducer sheath or the 18Fr equivalent Evolut PRO+ InLine Sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient. Search by the product name (e.g., Evolut) or model number. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO device is Medtronic CoreValve Evolut PRO System, and the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System. Quickly search hundreds of MRI safety related articles. 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 . Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. (This site is Exclusively Sponsored by BRACCO). Evolut provides an outstanding range of professionally prepared, "return to work" and "safety at work" training courses which you can now complete online at a time and pace suited to your personal situation. Avoid freezing. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. 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 . - (03:26). Heart. Find more detailed TAVRinformation, educationalresources, and tools. It is possible that some of the products on the other site are not approved in your region or country. 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. 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. Yj, van Melle JP, Freling HG, et al deployment knob and movement..., van Melle JP, Freling HG, et al is possible that some of the capsule statement that... On file ( > 20 clinical trials with over 20000 patients enrolled ) ) 1 113... ; Events ; Training and Continuing Education ; Inspections transcatheter aortic valve prosthesis-patient mismatch and exercise in... Additional feature information, educational resources, and tools combines exceptional valve design is taking patient outcomes and. 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