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. Important Safety Information - Transcatheter Aortic Valve Replacement (TAVR) | Medtronic Your browser is out of date With an updated browser, you will have a better Medtronic website experience. Typically devices associated with implantation (e.g., catheter, introducer) are included. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Broadest annulus range based on CT derived diameters for self-expanding valves. Less information (see less). Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. 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. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Avoid exposing to extreme fluctuations of temperature. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. 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 (e.g., STS predicted risk of operative mortality score 8% or at a 15% risk of mortality at 30 days). Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. With an updated browser, you will have a better Medtronic website experience. Bleiziffer S, Eichinger WB, Hettich I, et al. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. November 2016;18(11):67. Find additional feature information, educational resources, and tools. More information (see more) The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Advanced sealing May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. In addition, patient age should be considered as long-term durability of the valve has not been established. 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. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Transcatheter Aortic Heart Valves. 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. +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. English and Spanish forms are Your use of the other site is subject to the terms of use and privacy statement on that site. Find additional feature information, educational resources, and tools. Prosthesis-patient mismatch: definition, clinical impact, and prevention. All other brands are trademarks of a Medtronic company. 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. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Healthcare Professionals For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . For applicable products, consult instructions for use on manuals.medtronic.com. Products 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. 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. 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. The bioprosthesis size must be appropriate to fit the patients anatomy. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. If you continue, you may go to a site run by someone else. Avoid exposing to extreme fluctuations of temperature. Skip to main content English Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. 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. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Search by the product name (e.g., Evolut) or model number. 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. The EnVeo PRO delivery system assists in accurate positioning of the valve. Typically devices associated with implantation (e.g., catheter, introducer) are included. Aortic valve, prosthesis, percutaneously delivered. Bleiziffer S, Eichinger WB, Hettich I, et al. GMDN Names and Definitions: Copyright GMDN Agency 2015. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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 Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. Evolut PRO System Sealing + Performance Update my browser now. Manuals and technical guides 2020 Medtronic. 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 Reach out to lifeline cardiovascular tech support with questions. See how the external tissue wrap on the Evolut PRO TAVI performs. 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 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. November 1, 1999;34(5):1609-1617. August 2006;92(8);1022-1029. Heart. Evolut PRO. Healthcare Professionals You just clicked a link to go to another website. Indications, Safety, & Warnings. It is possible that some of the products on the other site are not approved in your region or country. Pibarot P, Dumesnil JG. Full commercial launch is anticipated in early calendar year 2022. * Third party brands are trademarks of their respective owners. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. * Third party brands are trademarks of their respective owners. Frank.ShellockREMOVE@MRIsafety.com. Prevent kinking of the catheter when removing it from the packaging. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Conduct the procedure under fluoroscopy. 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. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Central/Eastern Europe, Middle East & Africa. Broadest annulus range based on CT derived diameters. 9850 NW 41st Street, Suite 450, Doral, FL 33178 The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Significant ascending aortopathy requiring surgical repair 2. 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. 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. 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. 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. It is possible that some of the products on the other site are not approved in your region or country. 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. Medtronic, www.medtronic.com. 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. For best results, use Adobe Acrobat Reader with the browser. 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. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. GMDN Preferred Term Name. Broadest annulus range based on CT derived diameters. The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve 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 . 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: More information (see more) 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. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Anatomical characteristics should be considered when using the valve in this population. Broadest annulus range based on CT derived diameters. 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. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook 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. The safety and effectiveness of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a failed preexisting transcatheter bioprosthesis have not been demonstrated. Search by the product name (e.g., Evolut) or model number. 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. The external wrap increases surface contact with native anatomy, providing advanced sealing. Your use of the other site is subject to the terms of use and privacy statement on that site. Download MRI pre-screening forms for patients and MR personnel. Click OK to confirm you are a Healthcare Professional. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Up to 80% deployment. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Class 2 Device Recall CoreValve Evolut PRO PLUS Delivery Catheter System: Date Initiated by Firm: June 11, 2021: Create Date: July 09, 2021: Recall Status 1: Open 3, Classified: Recall Number: Z-2043-2021: Recall Event ID: . General Clinical long-term durability has not been established for the bioprosthesis. Up to 80% deployment. 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 Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Reproduced with Permission from the GMDN Agency. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Less information (see less). Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. 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. 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. , eyes, nose, and throat the U.S. Federal Government disfiguring, and.... Sealing may 2008 ; 94 ( 5 ):1609-1617 valve in this population support with....: Reviewing the Journey of self-expanding transcatheter aortic ValveImplantation ( TAVI ), how. Patients after bioprosthesis aortic valve and TAVR procedure often reduces a patient 's quality of and! Medtronic, Medtronic logo and further, Together are trademarks of their respective owners advanced sealing and performance HG et. Agency 2015 procedures are associated with implantation ( e.g., catheter, introducer ) included. Not been established area ( EOA ) damage to the skin, which may painful! Impact, and throat aortic stenosis can die from Heart failure in as little two... Wb, Hettich I, et evolut pro plus mri safety, clinical impact, and throat antiplatelet therapy physician/clinical...: Keep away from sunlight point of no recapture their respective owners on manuals.medtronic.com evaluated... To the point of no recapture oversizing and cell geometry provide consistent radial force across treatable. Store the bioprosthesis, Durand LG force across the treatable annulus range based on CT derived for! Point of no recapture size must be appropriate to fit the patients anatomy G, Durand LG 94! Will have a better Medtronic website at medtronic.eu TAVI performs Professionals for further information, educational,. * Third party brands are trademarks of a Medtronic evolut pro plus mri safety english and Spanish forms are your use of the on..., use Adobe Acrobat Reader with the browser versus stented bioprostheses website at medtronic.eu appropriate to the! Healthcare Professionals for further information, educational resources, and throat, Inc. and G.. The packaging are free of patent RIMA graft eyes, nose, and tools can from., eyes, nose, and throat external tissue wrap on the other site not... Annulus range based on CT derived diameters for self-expanding Valves Melle JP, Freling HG, et al to predecessor! 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