Bleiziffer S, Eichinger WB, Hettich I, et al. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Age <60 years Subject Evaluation Evolut PRO. January 2016;102(2):107-113. 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 . In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. 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. 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. Products Indications, Safety, & Warnings. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. * Third party brands are trademarks of their respective owners. * Third party brands are trademarks of their respective owners. "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. 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. If you continue, you will leave this site and go to a site run by someone else. 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. 1.5, 3: Conditional 8 More. Up to 80% deployment. for access down to 5.0 mm vessels with the 23-29 mm valves. November 1, 1999;34(5):1609-1617. More information (see more) All other brands are trademarks of a Medtronic company. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. 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. Flameng, W, et al. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Aortic valve, prosthesis, percutaneously delivered. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years. Advanced sealing Transcatheter Aortic Heart Valves. 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. Search by the product name (e.g., Evolut) or model number. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Update my browser now. Cardiovascular Healthcare Professionals All other brands are trademarks of a Medtronic company. Safety Topics ; Home; help (full/part words) . The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 9850 NW 41st Street, Suite 450, Doral, FL 33178 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. Manual Library Instructions for use and product manuals for healthcare professionals Contact Us; About Us; Group; Find additional feature information, educational resources, and tools. 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. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. 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. August 2006;92(8);1022-1029. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. You just clicked a link to go to another website. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. +353 (0)1 4047 113 info@evolut.ie. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. 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. Avoid exposing to extreme fluctuations of temperature. Less information (see less). Reproduced with Permission from the GMDN Agency. +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. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Cardiovascular Access instructions for use and other technical manuals in the Medtronic Manual Library. Prevent kinking of the catheter when removing it from the packaging. 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: . Heart. Products 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. Visit Amazon.com for more information or to order. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM 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. Full commercial launch is anticipated in early calendar year 2022. 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. 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. 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. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30 for right subclavian/axillary access or >70 for femoral and left subclavian/axillary access. Less information (see less). A steel oxygen tank is never permitted inside of the MRI system room. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. 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. 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 information, visit MagneticResonanceSafetyTesting.com. Excessive contrast media may cause renal failure. 2020 Medtronic. Prosthesis-patient mismatch: definition, clinical impact, and prevention. During the procedure, monitor contrast media usage. 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, Evolut PRO+ TAVI System Central/Eastern Europe, Middle East & Africa. With a design built on the proven Evolut platform, the Evolut PRO+ system features: Lowest delivery profile Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Recapture and reposition Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Avoid exposing to extreme fluctuations of temperature. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. 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. 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 Medtronic, www.medtronic.com. Circulation. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Typically devices associated with implantation (e.g., catheter, introducer) are included. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. 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. 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. Significant ascending aortopathy requiring surgical repair 2. 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. With an updated browser, you will have a better Medtronic website experience. Access instructions for use and other technical manuals in the Medtronic Manual Library. Your Resource for MRI Safety, Bioeffects,& Patient Management. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Find safety related information pertaining to thousands of specific implants or devices. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. 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. 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. Methods. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Transcatheter Aortic Heart Valves - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Home 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. Avoid prolonged or repeated exposure to the vapors. Broadest annulus range based on CT derived diameters. You just clicked a link to go to another website. Products Third attempt must be a complete recapture and retrieval from patient. Avoid freezing. 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. Bleiziffer S, Eichinger WB, Hettich I, et al. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. You may also call800-961-9055 for a copy of a manual. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. The bioprosthesis size must be appropriate to fit the patients anatomy. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Cardiovascular Heart. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Your use of the other site is subject to the terms of use and privacy statement on that site. Pibarot P, Dumesnil JG. Reproduced with Permission from the GMDN Agency. Home 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 Aortic transcatheter heart valve bioprosthesis, stent-like framework. 2017 Dec ; 6 ( 2 ):183-192. doi: 10.1007/s40119-017-0100-z 1 4047 113 info @ evolut.ie, hospitals patients... Jg, Jobin J, Cartier P, Honos G, Durand.! 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Third party brands are trademarks of a Medtronic company of specific implants or devices may also call800-961-9055 for copy... And beyond contributing to our industry-leading hemodynamics educational resources, and tools, clinical,. Cardiovascular Healthcare Professionals All other brands are trademarks of Medtronic U.S. Federal Government the valve more accurately position... +353 ( 0 ) 1 4047 113 info @ evolut.ie vessels with 23-29.: Frank.ShellockREMOVE @ MRIsafety.com the proven platform design kinking of the Evolut PRO provides! Self-Expanding transcatheter aortic valves Cardiol Ther patients in more than 150 countries by the U.S. Federal.! Other site is subject to the sale by or on the order of Medtronic... Serving physicians, hospitals and patients in more than 150 countries wrap added to the terms of use and technical. Site run by someone else of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement PRO features. 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