Avoid freezing. Update my browser now. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Transcatheter Aortic Heart Valves Ascending aorta diameter >4.5 cm 3. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland Heart. For applicable products, consult instructions for use on manuals.medtronic.com. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Healthcare Professionals Contact Us; About Us; Group; Advanced sealing 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. Healthcare Professionals It provides the lowest delivery profile and added surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. 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. 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 Your use of the other site is subject to the terms of use and privacy statement on that site. A steel oxygen tank is never permitted inside of the MRI system room. 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. Typically devices associated with implantation (e.g., catheter, introducer) are included. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Your use of the other site is subject to the terms of use and privacy statement on that site. Products 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. Update my browser now. 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 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. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. You just clicked a link to go to another website. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Actual results may differ materially from anticipated results. Avoid prolonged or repeated exposure to the vapors. Reach out to lifeline cardiovascular tech support with questions. With an updated browser, you will have a better Medtronic website experience. Reproduced with Permission from the GMDN Agency. Heart. Bleiziffer S, Eichinger WB, Hettich I, et al. 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. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Avoid exposing to extreme fluctuations of temperature. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. August 2006;92(8);1022-1029. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Cardiovascular Broadest annulus range based on CT derived diameters. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve 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. for access down to 5.0 mm vessels with the 23-29 mm valves. Search by the product name (e.g., Evolut) or model number. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. Your Resource for MRI Safety, Bioeffects,& Patient Management. 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. Click OK to confirm you are a Healthcare Professional. Recapture and reposition Products GMDN Names and Definitions: Copyright GMDN Agency 2015. It is possible that some of the products on the other site are not approved in your region or country. GMDN Names and Definitions: Copyright GMDN Agency 2015. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. 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. 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. Age <60 years Subject Evaluation Your use of the other site is subject to the terms of use and privacy statement on that site. 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. J Am Coll Cardiol. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Find additional feature information, educational resources, and tools. If you continue, you will leave this site and go to a site run by someone else. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Visit Amazon.com for more information or to order. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. Damage may result from forceful handling of the catheter. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Prevent kinking of the catheter when removing it from the packaging. 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). Update my browser now. 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. Flameng, W, et al. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . 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. Update my browser now. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. 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. Typically devices associated with implantation (e.g., catheter, introducer) are included. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. With an updated browser, you will have a better Medtronic website experience. Shellock R & D Services, Inc. email Conduct the procedure under fluoroscopy. GMDN Definition. 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. Reach out to LifeLine CardioVascular Tech Supportwith questions. These legacy and new design features provide the following sealing mechanisms: The Evolut TAVI platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI 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. Download MRI pre-screening forms for patients and MR personnel. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. +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. We currently do not have this item in stock, but we can email you as soon as it is available. Third attempt must be a complete recapture and retrieval from patient. Products Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. If you continue, you may go to a site run by someone else. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Reproduced with Permission from the GMDN Agency. Training is available through AppliedRadiology.com. January 2016;102(2):107-113. * Third party brands are trademarks of their respective owners. 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. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. Broadest annulus range* Indications, Safety, & Warnings. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Transcatheter Aortic Heart Valves Quickly search hundreds of MRI safety related articles. 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. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. - (03:26). Update my browser now. Products Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Healthcare Professionals 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. Avoid freezing. Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. +353 (0)1 4047 113 info@evolut.ie. 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 Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. 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. 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. GMDN Preferred Term Name. 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. Home Less information (see less). The Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. Circulation. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. More information (see more) available. Skip to main content English 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 General Clinical long-term durability has not been established for the bioprosthesis. Find additional feature information, educational resources, and tools. Aortic valve, prosthesis, percutaneously delivered. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. 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. 2020 Medtronic. 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