Reproduced with Permission from the GMDN Agency. Conduct the procedure under fluoroscopy. Training is available through AppliedRadiology.com. Lowest delivery profile Flameng, W, et al. Medtronic, www.medtronic.com. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Medtronic, www.medtronic.com 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 Your use of the other site is subject to the terms of use and privacy statement on that site. Refer to the Instructions for Use for available sizes. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. Healthcare Professionals for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. 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. 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. Less information (see less). Less information (see less). The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI (This site is Exclusively Sponsored by BRACCO). Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Actual results may differ materially from anticipated results. Find additional feature information, educational resources, and tools. Products 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). Advanced sealing 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% Prosthesis-patient mismatch: definition, clinical impact, and prevention. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. It is possible that some of the products on the other site are not approved in your region or country. Reproduced with Permission from the GMDN Agency. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Avoid exposing to extreme fluctuations of temperature. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Heart. Avoid exposing to extreme fluctuations of temperature. 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). More information (see more) 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. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. Avoid freezing. Healthcare Professionals Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, R System, the commercial name of the Evolut, PRO+ System, and the commercial name of the Evolut, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade, coronary occlusion, obstruction, or vessel spasm (including acute coronary closure), cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention), emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty), prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement prosthetic valve migration/embolization, delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time, delivery catheter system component migration/embolization, stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits, individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure, major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding), vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis), conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker. Evolut PRO System Sealing + Performance 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. Significant ascending aortopathy requiring surgical repair 2. 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. 2020 Medtronic. 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. Click OK to confirm you are a Healthcare Professional. 2010; 121:2123-2129. Manual Library Instructions for use and product manuals for healthcare professionals Today, the Evolut PRO+ valve design means no tradeoffs. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. With an updated browser, you will have a better Medtronic website experience. Products Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Manuals and technical guides for access down to 5.0 mm vessels with the 23-29 mm valves. Broadest annulus range* The EnVeo PRO delivery system assists in accurate positioning of the valve. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . Special Storage Condition, Specify: Store the bioprosthesis at room temperature. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient 40mmHg, or a peak aortic-jet velocity 4.0m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient <40mmHg, and a peak aortic-jet velocity <4.0 m/s; with untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve; patients with liver failure (Child-Pugh Class C); with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; patients who are pregnant or breastfeeding. Search by the product name (e.g., Evolut) or model number. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. * Third party brands are trademarks of their respective owners. Up to 80% deployment. 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. Find more detailed TAVRinformation, educationalresources, and tools. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Heart. 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. You just clicked a link to go to another website. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. For applicable products, consult instructions for use on manuals.medtronic.com. In addition, patient age should be considered as long-term durability of the valve has not been established. For best results, use Adobe Acrobat Reader with the browser. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. 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. 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. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Typically devices associated with implantation (e.g., catheter, introducer) are included. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Safety Topics ; Home; help (full/part words) . We currently do not have this item in stock, but we can email you as soon as it is available. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. For applicable products, consult instructions for use on manuals.medtronic.com. Healthcare Professionals 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+ GO TO THE LIBRARY (opens new window) Bleiziffer S, Eichinger WB, Hettich I, et al. Home Less information (see less). Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. ClinicalTrials.gov Identifier: NCT02701283 Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. It is possible that some of the products on the other site are not approved in your region or country. +353 (0)1 4047 113 info@evolut.ie. Heart. Products 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. Click OK to confirm you are a Healthcare Professional. 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 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 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. 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. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM 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. 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. 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. Cardiovascular Heart Valves and Annuloplasty Rings More. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. 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. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland August 2006;92(8);1022-1029. Heart. January 2016;102(2):107-113. Evolut PRO. 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. If you continue, you may go to a site run by someone else. 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 . Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Transcatheter Aortic Heart Valves. It is possible that some of the products on the other sitenot be licensed for sale in Canada. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. 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. Update my browser now. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Third attempt must be a complete recapture and retrieval from patient. Recapture and reposition 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. 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