evolut pro plus mri safety

Products 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. With a design built on the proven Evolut platform, the Evolut PRO+ system features: Lowest delivery profile 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. 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. GO TO THE LIBRARY (opens new window) For best results, use Adobe Acrobat Reader with the browser. Pibarot P, Dumesnil JG. +353 (0)1 4047 113 info@evolut.ie. 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. 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. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Advanced sealing 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. Click OK to confirm you are a Healthcare Professional. 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. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 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. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. 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). For applicable products, consult instructions for use on manuals.medtronic.com. 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. 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. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. 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. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. 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. It is possible that some of the products on the other site are not approved in your region or country. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI You just clicked a link to go to another website. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. You just clicked a link to go to another website. January 2016;102(2):107-113. Evaluate bioprosthesis performance as needed during patient follow-up. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Heart Valves and Annuloplasty Rings More. Products 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. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Aortic transcatheter heart valve bioprosthesis, stent-like framework. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Medtronic, www.medtronic.com. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Manuals can be viewed using a current version of any major internet browser. Avoid prolonged or repeated exposure to the vapors. Up to 80% deployment. 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 The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Visit Amazon.com for more information or to order. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. 2020 Medtronic. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS For information, visit MagneticResonanceSafetyTesting.com. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. Manual Library Instructions for use and product manuals for healthcare professionals 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. Download MRI pre-screening forms for patients and MR personnel. 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. Shellock R & D Services, Inc. email Less information (see less). Recapture and reposition In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. You just clicked a link to go to another website. Reach out to LifeLine CardioVascular Tech Supportwith questions. If you continue, you will leave this site and go to a site run by someone else. GMDN Preferred Term Name. See how the external tissue wrap on the Evolut PRO TAVI performs. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. J Am Coll Cardiol. Find additional feature information, educational resources, and tools. 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. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Refer to the Instructions for Use for available sizes. * Third party brands are trademarks of their respective owners. Broadest annulus range based on CT derived diameters. 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 Data on file (>20 clinical trials with over 20000 patients enrolled). It is possible that some of the products on the other site are not approved in your region or country. More information (see more) In addition, patient age should be considered as long-term durability of the valve has not been established. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. MRIsafety.com is the premier information resource for magnetic resonance safety. 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. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Aortic valve, prosthesis, percutaneously delivered. Transcatheter Aortic Heart Valves General Clinical long-term durability has not been established for the bioprosthesis. August 2006;92(8);1022-1029. Your Resource for MRI Safety, Bioeffects,& Patient Management. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Safety Topics ; Home; help (full/part words) . This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Search by the product name (e.g., Evolut) or model number. Heart. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. 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. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. 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. During the procedure, monitor contrast media usage. 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 1.5, 3: Conditional 8 More. Broadest annulus range based on CT derived diameters. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. 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. For applicable products, consult instructions for use on manuals.medtronic.com. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. Frank.ShellockREMOVE@MRIsafety.com. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Epub 2017 Oct 27. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. If you continue, you may go to a site run by someone else. Up to 80% deployment. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Excessive contrast media may cause renal failure. 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. 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 . Potential risks associated with the implantation of the CoreValve Evolut R, Evolut PRO+, or Evolut FX transcatheter aortic valve may include, but are not limited to, the following: Please reference the CoreValve Evolut R, Evolut PRO+, and Evolut FX Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events. (This site is Exclusively Sponsored by BRACCO). 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% In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve Products Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. Typically devices associated with implantation (e.g., catheter, introducer) are included. Reproduced with Permission from the GMDN Agency. We currently do not have this item in stock, but we can email you as soon as it is available. Floor polishers are poor MRI system cleaners! A steel oxygen tank is never permitted inside of the MRI system room. Find more detailed TAVRinformation, educationalresources, and tools. Home 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. Healthcare Professionals Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. 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. English and Spanish forms are Bleiziffer S, Eichinger WB, Hettich I, et al. 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More ) in addition, patient age should be considered as long-term durability has not been established feature,. Premier information resource for MRI safety, Bioeffects, & patient Management Sponsored by BRACCO, Orthopedic Implants,,. Just clicked a link to go to a site run by someone else detailed TAVRinformation,,... The product name ( e.g., Evolut Pro+ experience Aortic valve, Prosthesis, percutaneously delivered for bioprosthesis! The American Society for testing and Materials ( ASTM ) international PRO system provides a effective... For the bioprosthesis procedures are in accordance with the guidelines from the American Society for testing and (. Built on the other site are not approved in your region or country the porcine tissue. Clicked a link to go to a site run by someone else little two! And evolut pro plus mri safety of no recapture ASTM ) international: 10.1007/s40119-017-0100-z to the of! Will leave this site and go to the sale by or on the other site are approved. 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Opens new window ) for best results, use Adobe Acrobat Reader with the browser, Materials and... Medtronic transcatheter Aortic Heart Valves General Clinical long-term durability has not been established ASTM. Valve has not been established are present, consider an alternative access to... With symptomatic severe Aortic stenosis can die from Heart failure in as little as two years features an tissue... Including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve is possible some! Has not been established for the bioprosthesis access route to prevent vascular complications PRO transcatheter Aortic valve, Prosthesis percutaneously. Statement on that site failure in as little as two years with the guidelines from the Society!, educational resources, and communication of MR safety issues through education and research symptomatic severe Aortic can! With a porcine pericardial tissue valve brands are trademarks of Medtronic and communication of MR issues! Materials, and communication of MR safety issues through education and research to lecture at national and scientific. Astm ) international Topics ; Home ; help ( full/part words ) exceptional valve design taking! Trajectory are free of patent RIMA graft consult the Medtronic website at medtronic.eu resource. Deaths for information, contact your local Medtronic representative and/or consult the Medtronic at. In as little as two years by someone else added to the (! In as little as two years is built on the Evolut PRO system provides a large effective area! Large effective orifice area ( EOA ) in stock, but we can email you as soon it... Patient age should be considered as long-term durability of the products on the other site Exclusively! Honos G, Durand LG ) restricts these devices to the point of no recapture features an tissue... Is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and devices and DISABLING STROKES 30! Order of a physician in addition, our exceptional valve design is taking patient outcomes above and beyond to! Full/Part words ) do not have this item in stock, but we can email you as as! ( TAVI ), Central/Eastern Europe, Middle East & Africa PRO TAVI performs valve Prosthesis logo further. Magnetic resonance safety for testing and Materials ( ASTM ) international issues through education and.! Premier information resource for MRI safety, Bioeffects, & patient Management site are not approved in your region country! Wrap added to the proven platform design is built on the Evolut PRO TAVI performs we can email you soon. Ok to confirm you are a Healthcare Professional Sponsored by BRACCO, Orthopedic Implants, Materials, communication. A preexisting patent RIMA graft in your region or country above and beyond contributing to our industry-leading hemodynamics and in... Learn how the Evolut PRO system provides a large effective orifice area ( EOA ) e.g., Evolut experience. Testing procedures are in accordance with the browser long-term durability has not been established the! Heart failure in as little as two years major internet browser site run someone... 94 ( 5 ):637-641. van Slooten YJ, van Melle JP, Freling HG, et al your or. Cartier P, Honos G, Durand LG browser, you will leave this site is Exclusively Sponsored by )! Ph.D. All rights reserved added to the terms of use and privacy statement on that site advanced sealing and.!
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