Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Manuals and technical guides 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. Manuals can be viewed using a current version of any major internet browser. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. 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. Heart. 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. Indications, Safety, & Warnings. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. Skip to main content English This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. 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. Typically devices associated with implantation (e.g., catheter, introducer) are included. Full commercial launch is anticipated in early calendar year 2022. 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 In addition, patient age should be considered as long-term durability of the valve has not been established. Search by the product name (e.g., Evolut) or model number. Home For applicable products, consult instructions for use on manuals.medtronic.com. Less information (see less). The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. Evolut PRO System Sealing + Performance Contact Us; About Us; Group; The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. GMDN Definition. 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% For applicable products, consult instructions for use on manuals.medtronic.com. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Click OK to confirm you are a Healthcare Professional. 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. Prior to the procedure, measure the patients creatinine level. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. 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 . The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. 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 Today, the Evolut PRO+ valve design means no tradeoffs. Access instructions for use and other technical manuals in the Medtronic Manual Library. With an updated browser, you will have a better Medtronic website experience. 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. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. 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. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. 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. Visit Amazon.com for more information or to order. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve Recapture and reposition Third attempt must be a complete recapture and retrieval from patient. +353 (0)1 4047 113 info@evolut.ie. Update my browser now. Typically devices associated with implantation (e.g., catheter, introducer) are included. 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. Transcatheter Aortic Heart Valves 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. Less information (see less). More information (see more) Healthcare Professionals Home Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Avoid freezing. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland Central/Eastern Europe, Middle East & Africa. Aortic valve, prosthesis, percutaneously delivered. 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. Evolut PRO+ Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. +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. The bioprosthesis size must be appropriate to fit the patients anatomy. Evolut PRO. 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. It is possible that some of the products on the other site are not approved in your region or country. Read our disclaimer for details. 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. Bleiziffer S, Eichinger WB, Hettich I, et al. Avoid prolonged or repeated exposure to the vapors. 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. Lowest delivery profile Heart. Less information (see less). The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. 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. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Training is available through AppliedRadiology.com. Third attempt must be a complete recapture and retrieval from patient. Broadest annulus range based on CT derived diameters for self-expanding valves. Reproduced with Permission from the GMDN Agency. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. Cardiovascular May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. J Am Coll Cardiol. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Click OK to confirm you are a Healthcare Professional. See how the external tissue wrap on the Evolut PRO TAVI performs. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Curr Treat Options Cardiovasc Med. Typically devices associated with implantation (e.g., catheter, introducer) are included. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). The valve can be partially or fully recaptured up to three times prior to the point of no recapture. 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. MRIsafety.com is the premier information resource for magnetic resonance safety. 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: . More information (see more) It is possible that some of the products on the other site are not approved in your region or country. Ascending aorta diameter >4.5 cm 3. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Broadest annulus range* Evaluate bioprosthesis performance as needed during patient follow-up. 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