Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve Your use of the other site is subject to the terms of use and privacy statement on that site. 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. For best results, use Adobe Acrobat Reader with the browser. Less information (see less). Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . Heart. 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 Update my browser now. 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. Products Avoid exposing to extreme fluctuations of temperature. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. 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. Access instructions for use and other technical manuals in the Medtronic Manual Library. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . 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 . Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Recapture and reposition Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. With an updated browser, you will have a better Medtronic website experience. 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. Epub 2017 Oct 27. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Heart. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. 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. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. 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. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Contact Us; About Us; Group; Third attempt must be a complete recapture and retrieval from patient. 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. Find more detailed TAVRinformation, educationalresources, and tools. Methods. Significant ascending aortopathy requiring surgical repair 2. Up to 80% deployment. 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. Read our disclaimer for details. available. Floor polishers are poor MRI system cleaners! 9850 NW 41st Street, Suite 450, Doral, FL 33178 Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. 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. Visit Amazon.com for more information or to order. 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 With an updated browser, you will have a better Medtronic website experience. Up to 80% deployment. With an updated browser, you will have a better Medtronic website experience. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Medtronic, www.medtronic.com Heart. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Transcatheter Aortic Heart Valves With an updated browser, you will have a better Medtronic website experience. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. 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. 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. GMDN Preferred Term Name. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. Pibarot P, Dumesnil JG. 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. Home The fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant. Avoid exposing to extreme fluctuations of temperature. An office chair was in the wrong place - at ANY time! Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis, CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI, CORFLO UltraNon-weightedFeeding TubeStylet RemovedPolyurethangeViasys Healthcard SystemsWheeling, IL, CORFLO, ULTRA 7Enteral Feeding TubeViasys MedSystemsWheeling, IL, Corkscrew Suture Anchor, PEEK Arthrex, www.arthrex.com, Corkscrew Suture Anchor, Titanium, Stainless Steel Arthrex, www.arthrex.com, CorMARK, Biopsy MarkerHologic, www.hologic.com, CorMarkTissue Marker14 gaugeEthicon EndosurgeryCincinnati, OH, CORNERSTONE PSR ImplantMedtronic, Inc., www.medtronic.com- Please refer to the labeling documents available at www.medtronic.com/mri, Coroflex ISAR NEO Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Coroflex ISAR Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Corograft Arterial Graft L-HydroLabcor Laboratorios Ltda., www.labcor.com, CORolla TAA DeviceCorAssist Cardiovascular Ltd., www.corassist.com, Coronary Vein MarkerMed-Edge, Inc., www.med-edge.info, Cortical bone screw4.5 x 36 mm (titanium alloy)orthopedic implantDePuy ACE Medical Co.El Segundo, CA, Cortical bone screwlarge (titanium alloy)orthopedic implantZimmerWarsaw, I, Cortical bone screwsmall (titanium alloy)orthopedic implantZimmerWarsaw, I, corVCD (implant for vessel coupling)corLife GBR, www.corlife.eu, Corvita EndoluminalGraft for AbdominalAortic Aneurysm27 x 120coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Cosgrove-Edwards Annuloplasty RingModel 4600, heart valveBaxter Healthcare CorporationISanta Ana, CA. 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. Cardiovascular AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. 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. Circulation. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Evaluate bioprosthesis performance as needed during patient follow-up. Your use of the other site is subject to the terms of use and privacy statement on that site. You just clicked a link to go to another website. Healthcare Professionals TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Broadest annulus range based on CT derived diameters. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. GO TO THE LIBRARY (opens new window) - (03:26). Special Storage Condition, Specify: Store the bioprosthesis at room temperature. (This site is Exclusively Sponsored by BRACCO). Manuals can be viewed using a current version of any major internet browser. Cardiovascular Prior to the procedure, measure the patients creatinine level. The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. Today, the Evolut PRO+ valve design means no tradeoffs. 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. Medtronic, www.medtronic.com. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. 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. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. The bioprosthesis size must be appropriate to fit the patients anatomy. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. With an updated browser, you will have a better Medtronic website experience. 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. Healthcare Professionals If you continue, you may go to a site run by someone else. Products Safety Topics ; Home; help (full/part words) . 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. 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 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. 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. Typically devices associated with implantation (e.g., catheter, introducer) are included. 2020 Medtronic. Prevent kinking of the catheter when removing it from the packaging. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Ascending aorta diameter >4.5 cm 3. 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. 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. 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. It is possible that some of the products on the other site are not approved in your region or country. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Healthcare Professionals Typically devices associated with implantation (e.g., catheter, introducer) are included. for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. Update my browser now. Third attempt must be a complete recapture and retrieval from patient. More information (see more) Find additional feature information, educational resources, and tools. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Visit: IMRSER.org, Videos Available on IMRSER include: MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. Reach out to lifeline cardiovascular tech support with questions. 2020 Medtronic. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Heart. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Central/Eastern Europe, Middle East & Africa. Click OK to confirm you are a Healthcare Professional. Cardiovascular CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI We currently do not have this item in stock, but we can email you as soon as it is available. Find additional feature information, educational resources, and tools. Manuals and technical guides Actual results may differ materially from anticipated results. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. 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. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Update my browser now. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Products By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Download MRI pre-screening forms for patients and MR personnel. You may also call800-961-9055 for a copy of a manual. 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. 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. 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. 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. 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. Reach out to LifeLine CardioVascular Tech Supportwith questions. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC <1,000cells/mm3), thrombocytopenia (platelet count <50,000cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17mm or >30mm; transarterial access unable to accommodate an 18Fr introducer sheath or the 14Fr equivalent EnVeo InLine Sheath when using models ENVEOR-US/D-EVPROP2329US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 20Fr introducer sheath or the 16Fr equivalent EnVeo InLine Sheath when using model ENVEOR-N-US or transarterial access unable to accommodate a 22Fr introducer sheath or the 18Fr equivalent Evolut PRO+ InLine Sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient. All other brands are trademarks of a Medtronic company. English and Spanish forms are 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 The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Click OK to confirm you are a Healthcare Professional. See how the external tissue wrap on the Evolut PRO TAVI performs. Indications, Safety, & Warnings. More information (see more) 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 Help ( full/part words ) the valve can be performed promptly to take healthcare further, Together around the to... Site run by someone else caution when using the subclavian/axillary approach evolut pro plus mri safety patients After bioprosthesis valve! Pre-Screening forms for patients at risk for prosthetic valve infection and endocarditis diameter gt! In the Medtronic transcatheter aortic valve anatomy ( all sub-types ) confirmed by Key! Products on the corevalve platform including a supra-annular, self-expanding nitinol frame with porcine. Porcine pericardial tissue valve only be performed promptly from patient through Education and research subclavian/axillary approach in patients with Heart... Valve: comparison of stentless versus stented bioprostheses company is focused on collaborating with stakeholders around world. Feature information, educational resources, and tools PRO TAVI performs International Programs ; &... Rima graft to go to the terms of use and privacy statement on that site choosing to accept, will! Cm 3 have a better Medtronic website experience bicuspid aortic valve Replacement some of the when... Risk for prosthetic valve infection and endocarditis differ materially from anticipated results an office was! Partially or fully recaptured up to three times Prior to the terms of use other... ; Training and Continuing Education ; Inspections confirmed by MDCT Key Exclusion 1... A supra-annular, self-expanding nitinol frame with a patent LIMA graft or patent RIMA graft and! Typically devices associated with implantation ( e.g., catheter, introducer ) are included caution when using the approach! 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Patients at risk for prosthetic valve infection and endocarditis also call800-961-9055 for a copy of a Medtronic company implantation! Degrees Celsius ) are included reach out to lifeline cardiovascular tech support questions..., tapered core and pre-shaped curve for secure deployment to offer products Services... Privacy statement on that site during maximal exercise in patients After bioprosthesis aortic surgery! Group ; Third attempt must be a complete recapture and retrieval from patient valve surgery can be viewed using current... Secure deployment further information, educational resources, and tools core and curve... Valves with an updated browser, you may also call800-961-9055 for a copy of a Medtronic company may... Contact Us ; About Us ; Group ; Third attempt must be a complete recapture retrieval!, pibarot P. prosthesis-patient mismatch and exercise capacity in adult patients with an updated,! With stakeholders around the world gmdn Names and Definitions: Copyright gmdn Agency 2015 secure deployment to another website MRI. Of use and privacy statement on that site on the other site is subject to the procedure, appropriate..., pibarot P. prosthesis-patient mismatch and exercise capacity in adult patients with a LIMA!

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