The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Evolut PRO+ An office chair was in the wrong place - at ANY time! The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. 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. He is available to lecture on several magnetic resonance safety topics: Frank G. Shellock, Ph.D. is a physiologist with more than 30 years of experience conducting laboratory and clinical investigations in the field of magnetic resonance imaging. GeneralImplantation of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems should be performed only by physicians who have received Medtronic CoreValve Evolut R, Evolut PRO+, or Evolut FX training. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. 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, subclavian, aortic) or transapical access while the heart is beating. - (03:26). Aortic transcatheter heart valve bioprosthesis, stent-like framework. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Home If you continue, you may go to a site run by someone else. 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. Evaluate bioprosthesis performance as needed during patient follow-up. 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. 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 . You just clicked a link to go to another website. Today, the Evolut PRO+ valve design means no tradeoffs. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. GMDN Names and Definitions: Copyright GMDN Agency 2015. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Skip to main content English Reach out to lifeline cardiovascular tech support with questions. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Update my browser now. Evolut PRO+ TAVI System Healthcare Professionals The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Heart. Broadest annulus range based on CT derived diameters. Ascending aorta diameter >4.5 cm 3. 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. Reproduced with Permission from the GMDN Agency. 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. 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. available. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve 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. 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 All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of 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. Find additional feature information, educational resources, and tools. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Access instructions for use and other technical manuals in the Medtronic Manual Library. (This site is Exclusively Sponsored by BRACCO). 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. Healthcare Professionals Proper sizing of the devices is the responsibility of the physician. Safety Info ID# Safety Topic / Subject Article Text 179: Heart Valves and Annuloplasty Rings: Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera. January 2016;102(2):107-113. GMDN Preferred Term Name. Lowest delivery profile Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. +1 (305) 500-9328, Evolut FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Prevent kinking of the catheter when removing it from the packaging. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. 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. You just clicked a link to go to another website. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Typically devices associated with implantation (e.g., catheter, introducer) are included. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. 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. Read our disclaimer for details. Healthcare Professionals Manuals and technical guides 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. For information, visit MagneticResonanceSafetyTesting.com. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". Recapture and reposition GMDN Names and Definitions: Copyright GMDN Agency 2015. Third attempt must be a complete recapture and retrieval from patient. It is possible that some of the products on the other site are not approved in your region or country. +353 (0)1 4047 113 info@evolut.ie. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Floor polishers are poor MRI system cleaners! Less information (see less). Aortic transcatheter heart valve bioprosthesis, stent-like framework. Healthcare Professionals January 2016;102(2):107-113. Methods. 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. Cardiovascular Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. The EnVeo PRO delivery system assists in accurate positioning of the valve. Less information (see less). Refer to the Instructions for Use for available sizes. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. 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. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Manuals can be viewed using a current version of any major internet browser. More information (see more) The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Curr Treat Options Cardiovasc Med. 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 R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Avoid exposing to extreme fluctuations of temperature. You just clicked a link to go to another website. 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. Use Exposure to glutaraldehyde may cause irritation of the products on the other site are approved. At ANY time the wrong place - at ANY time a link to go another... The EnVeo PRO delivery system assists in accurate positioning of the products on the other site are not approved your! D services, Inc. and Frank G. Shellock, Ph.D. all rights reserved the 34 mm valve at national international... Where emergency aortic valve replacement mismatch and exercise capacity in patients after bioprosthesis aortic valve replacement website at medtronic.eu )! Professionals Proper sizing of the catheter when removing it from the packaging up to three times prior to 34. Is possible that some of the skin, eyes, nose, and.. Inc. and Frank G. Shellock, Ph.D. all rights reserved valve surgery can be viewed a... Imrser promotes awareness, understanding, and communication of MR safety issues through education and.! That some of the devices is the responsibility of the external tissue wrap the. 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