Flameng, W, et al. PRODUCT DETAILS EXCEPTIONAL DESIGN CoreValve and Evolut TAVR Systems | Medtronic Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. See how the external tissue wrap on the Evolut PRO TAVI performs. Click OK to confirm you are a Healthcare Professional. 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. Patients who do not are more likely to have a stroke. Lowest delivery profile 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. Transcatheter Aortic Heart Valves Your use of the other site is subject to the terms of use and privacy statement on that site. 2020 Medtronic. Third attempt must be a complete recapture and retrieval from patient. 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. Explore our valve design and theperformance of the Evolut platform over time. per pulse sequence) in 1.5-Tesla and 3-Tesla MR systems, using an MR system reported, whole body averaged SAR of 2-W/kg or less, as follows: Highest temperature changes Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. See how the external tissue wrap on the Evolut PRO TAVI performs. Search by the product name (e.g., Evolut) or model number. Search by the product name (e.g., Evolut) or model number. 2010; 121:2123-2129. November 2016;18(11):67. Healthcare Professionals Up to 80% deployment. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Update my browser now. Raise your expectations for what is possiblewith the Evolut FX system. Healthcare Professionals You may also call 800-961-9055 for a copy of a manual. Reach out to LifeLine CardioVascular Tech Support with questions. 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. Language Remember My Preferences. Or, you may contact technical support online. DUBLIN, Aug. 24, 2021 / PRNewswire (opens new window) / -- 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. Indications, Safety, and Warnings Product Details Bleiziffer S, Eichinger WB, Hettich I, et al. With an updated browser, you will have a better Medtronic website experience. Update my browser now. Not doing so could result in injury or death. More information (see more) J Am Coll Cardiol. If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Medtronic MRI Resource Library Technical Information for Healthcare Professionals. August 2006;92(8);1022-1029. 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. With an updated browser, you will have a better Medtronic website experience. SPECIFICATIONS Evolut PRO+ TAV R BIOPROSTHESIS Evolut PRO+ 23 mm Valve Evolut PRO+ 26 mm Valve Model Number: EVPROPLUS-23US Size: 23 mm Aortic annulus diameter: 17*/18-20 mm Model Number: EVPROPLUS-26US Size: 26 mm Aortic annulus diameter: 20-23 mm LOADING SYSTEM Evolut PRO+ Loading System Model Number: L-EVPROP2329US During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. All other brands are trademarks of a Medtronic company. X'AD`4.$ 2 The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. The external wrap increases surface contact with native anatomy, providing advanced sealing. If you continue, you may go to a site run by someone else. TAVR currentlyis approvedfor patients withheart diseasedue to symptomatic severe aortic stenosis of the native valve, and patients with a failingsurgical aortic valve who are at high risk or extreme riskdue to symptomatic, severe aortic stenosis for complications during surgery. Less information (see less). 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. Medtronic MRI Verify allows you to look up the MR conditionality of a patient's Medtronic cardiac implantable electronic device based on the information available. Damage may result from forceful handling of the catheter. $/R$J101 THE List - MRI Safety The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic CoreValve Evolut Pro and Pro . Broadest annulus range based onCT-derived diameters. * Third party brands are trademarks of their respective owners. Flameng, W, et al. Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve Evolut PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR). Evolut PRO China Clinical Study - Full Text View - ClinicalTrials.gov Pibarot P, Dumesnil JG. Important Safety Information - Transcatheter Aortic Valve - Medtronic The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . 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. All other brands are trademarks of a Medtronic company. Reach out to LifeLine CardioVascular Tech Support with questions. Proper sizing of the devices is the responsibility of the physician. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. * Third party brands are trademarks of their respective owners. Evolut PRO+ - Transcatheter Aortic Heart Valves | Medtronic Transcatheter Aortic Heart Valves - Evolut R | Medtronic MRI safety information | Edwards Lifesciences Prevent kinking of the catheter when removing it from the packaging. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Treatments & Therapies t X 2010; 121:2123-2129. Healthcare Professionals What is Evolut pro valve made of? - Studybuff The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. AccessGUDID - DEVICE: Evolut PRO+ (00763000211127) Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Avoid prolonged or repeated exposure to the vapors. Your use of the other site is subject to the terms of use and privacy statement on that site. Third attempt must be a complete recapture and retrieval from patient. Update my browser now. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. The external wrap increases surface contact with native anatomy, providing advanced sealing. Premarket Approval (PMA) - Food and Drug Administration From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Seleccione su regin. Object Category Heart Valves and Annuloplasty Rings. Transcatheter Aortic Heart Valves. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. 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. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Transcatheter Aortic Heart Valves - Evolut PRO | 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 Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. 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. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. See how the external tissue wrap on the Evolut PRO TAV performs. Curr Treat Options Cardiovasc Med. Manuals can be viewed using a current version of any major internet browser. Safety Topic / Subject Heart Valves and Annuloplasty Rings. EVPROPLUS-29US: Medtronic Evolut Pro+ Transcatheter Aortic Valve 29mm 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 <4.0m/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. Veuillez slectionner votre rgion. Cardiovascular Heart. More information (see more) The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. At some point, the Medtronic TAVR valve may need tobe replaced. Cardiovascular Medtronic Launches Head-to-Head TAVR Study Comparing the Corevalve Pibarot P, Dumesnil JG. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Heart. January 2016;102(2):107-113. 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. Circulation. The Evolut PRO+ system offers the lowest delivery profile for 2329 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealingwith an external tissue wrap on all valve sizes. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. During the procedure, monitor contrast media usage. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. General Clinical long-term durability has not been established for the bioprosthesis. You just clicked a link to go to another website. %PDF-1.5 % Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Meet the Evolut R System. Medtronic, www.medtronic.com. * Third party brands are trademarks of their respective owners. PDF View Shellock R & D Services, Inc. email: . PDF PRO TAVR SPECIFICATIONS - asiapac.medtronic.com With an updated browser, you will have a better Medtronic website experience. Third attempt must be a complete recapture and retrieval from patient. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Heart Valves and Annuloplasty Rings More. Access instructions for use and other technical manuals in the Medtronic Manual Library. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. Evolut FX Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. We are here for you. 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 You just clicked a link to go to another website. Healthcare Professionals Dysfunctions of a Medtronic TAVR valve,including but not limited to: Valve frame does not open (expand) allthe way, Pannus the formation of scar tissuethat may cover or block the valve fromfunctioning normally, Wear, tear, or movement forward (prolapse)or backward (retraction) from the normalposition of the valve leaflets, A break in the stitches (sutures) of the valveframe or leaflets, Leakage through or around the valve orvalve frame, Incorrect position of the valve, either toohigh or too low, Regurgitation backward flow of bloodthrough the valve, Stenosis narrowing of the opening ofthe valve, Valve migration upward or downwardmovement of the device from where itwasoriginally placed, Embolism an abnormal particle (air, bloodclots) floating in the blood stream or attachedto an object, including the valve or deliverysystem component, Infection of the heart, blood, or other areas, Thrombosis (including valve thrombosis) blood clot, including a blood clot on the valve, Individual or multi-organ insufficiency or failure. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Heart Valves and Annuloplasty Rings More. With an updated browser, you will have a better Medtronic website experience. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. Home With an updated browser, you will have a better Medtronic website experience. 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. 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