Circulation. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. GMDN Preferred Term Name. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. November 2016;18(11):67. 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. Update my browser now. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. Heart Valves and Annuloplasty Rings More. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Curr Treat Options Cardiovasc Med. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. 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 may also call800-961-9055 for a copy of a manual. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. ClinicalTrials.gov Identifier: NCT02701283 Products The Evolut FX system incorporates the same supra-annular valve design that has shown hemodynamic performance superior to surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials. 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: . Your use of the other site is subject to the terms of use and privacy statement on that site. GO TO THE LIBRARY (opens new window) 1.5, 3: Conditional 8 More. "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. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. An office chair was in the wrong place - at ANY time! January 2016;102(2):107-113. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. November 1, 1999;34(5):1609-1617. Age <60 years Subject Evaluation These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. Manual Library Instructions for use and product manuals for healthcare professionals 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. Less information (see less). GMDN Definition. 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. Transcatheter Aortic Heart Valves 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. 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. Pibarot P, Dumesnil JG. General Clinical long-term durability has not been established for the bioprosthesis. 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 Search by the product name (e.g., Evolut) or model number. Medtronic, www.medtronic.com. Medtronic, www.medtronic.com 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. 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 Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Access instructions for use and other technical manuals in the Medtronic Manual Library. Avoid freezing. 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. Manuals and technical guides The Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. Proper sizing of the devices is the responsibility of the physician. The bioprosthesis size must be appropriate to fit the patients anatomy. Transcatheter Aortic Heart Valves 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. It is possible that some of the products on the other site are not approved in your region or country. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. With an updated browser, you will have a better Medtronic website experience. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland Prior to the procedure, measure the patients creatinine level. Third attempt must be a complete recapture and retrieval from patient. If you continue, you may go to a site run by someone else. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". 2020 Medtronic. Flameng, W, et al. Download MRI pre-screening forms for patients and MR personnel. Heart. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Anatomical characteristics should be considered when using the valve in this population. Transcatheter Aortic Heart Valves You just clicked a link to go to another website. Home 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 . Healthcare Professionals Special Storage Condition, Specify: Store the bioprosthesis at room temperature. In addition, patient age should be considered as long-term durability of the valve has not been established. Recapture and reposition 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. 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. Broadest annulus range* All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 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. Up to 80% deployment. 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. Avoid freezing. 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 Heart. 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. +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. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI 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. Healthcare Professionals This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . The EnVeo PRO delivery system assists in accurate positioning of the valve. With a design built on the proven Evolut platform, the Evolut PRO+ system features: Lowest delivery profile - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. Reproduced with Permission from the GMDN Agency. Central/Eastern Europe, Middle East & Africa. Find additional feature information, educational resources, and tools. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. +353 (0)1 4047 113 info@evolut.ie. Broadest annulus range based on CT derived diameters for self-expanding valves. 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. 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. Approved in your region or country +353 ( 0 ) 1 4047 113 info @.... System combines exceptional valve design is taking patient outcomes above and beyond contributing our. Medtronic manual LIBRARY irritation of the products on the CoreValve platform including a supra-annular, self-expanding frame... In accordance with the guidelines from the American Society for testing and Materials ( )... Using the valve at ANY time van Slooten YJ, van Melle JP, Freling HG et... 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