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. More information (see more) Indications, Safety, & Warnings. Heart. 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). (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W If 2 of these factors are present, consider an alternative access route to prevent vascular complications. Evolut PRO. At some point, the Medtronic TAVR valve may need tobe replaced. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. November 1, 1999;34(5):1609-1617. English. Update my browser now. Medtronic MRI Resource Library: Home This library contains technical information on whether an MRI scan can be performed and how to perform a scan on patients with Medtronic implantable devices. 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. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. With an updated browser, you will have a better Medtronic website experience. Home Products Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. Broadest annulus range based on CT derived diameters. J Am Coll Cardiol. 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. Flameng, W, et al. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Heart. 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. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Strength 1.5, 3. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and has the ability to treat the broadest annulus range* of any commercially available TAVR system. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. January 2016;102(2):107-113. Healthcare Professionals All other brands are trademarks of a Medtronic company. MRI-Related Heating In non-clinical testing, the implant/device produced the following temperature rises during MRI performed for 15-minutes (i.e. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. 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. Transcatheter Aortic Heart Valves 0 Pibarot P, Dumesnil JG. Click OK to confirm you are a Healthcare Professional. PRODUCT DETAILS EXCEPTIONAL DESIGN Up to 80% deployment. Up to 80% deployment. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. You just clicked a link to go to another website. Patients who do not are more likely to have a stroke. Or, you may contact technical support online. More information (see more) Conduct the procedure under fluoroscopy. Transcatheter Aortic Heart Valves. Third attempt must be a complete recapture and retrieval from patient. hb```lu eah(x B Evolut FX Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). Title Transcatheter Aortic Valve Replacement (TAVR) with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement (SAVR) Product Name Medtronic TAVR System: xEvolut PRO Transcatheter Aortic Valve (TAV) 23, 26, and 29 mm xEvolut R 23, 26, 29, and 34 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). The Evolut R valve was built on the proven design of our CoreValve platform and features a supra-annular, self-expanding nitinol frame with a low delivery profile. Explore our valve design and theperformance of the Evolut platform over time. Products Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. Products Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. Home Curr Treat Options Cardiovasc Med. 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. Veuillez slectionner votre rgion. The Evolut PRO valve features an external tissue wrap added to the proven platform design. If you continue, you may go to a site run by someone else. Avoid prolonged or repeated exposure to the vapors. Go . Manuals can be viewed using a current version of any major internet browser. Evolut PRO System Sealing + Performance 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. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. 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. Lowest delivery profile Evolut PRO. Evolut FX. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI All other brands are trademarks of a Medtronic company. With an updated browser, you will have a better Medtronic website experience. Products Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name Antibiotics maybe recommendedfor patients who are at risk of infections. US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. November 2016;18(11):67. With an updated browser, you will have a better Medtronic website experience. `)\;>! Safety Info ID# Safety Topic / Subject Article Text 179: . Circulation. Bench testing may not be indicative of clinical performance. It is possible that some of the products on the other site are not approved in your region or country. Find more detailed TAVRinformation, educationalresources, and tools. We are here for you. The Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap on all valve sizes. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 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. You may also call 800-961-9055 for a copy of a manual. Search by the product name (e.g., Evolut) or model number. 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. The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. * Third party brands are trademarks of their respective owners. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. 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. 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 < 17 mm. 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. t X Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. Reach out to LifeLine CardioVascular Tech Support with questions. Access instructions for use and other technical manuals in the Medtronic Manual Library. The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. Refer to the Instructions for Use for available sizes. Safety Topic / Subject Heart Valves and Annuloplasty Rings. 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. If you continue, you may go to a site run by someone else. This study is a prospective, single arm, multi-center . Anatomical characteristics should be considered when using the valve in this population. Complications at the area where the doctor cutthe skin or related to cutting the skin, includingbut not limited to: Hematoma blood collecting under the skin, Pseudoaneurysm blood collecting on theoutside of a vessel wall causing a balloon-likewidening, Irreversible nerve damage permanentdamage to nerves, Compartment syndrome squeezing ofnerves and muscles in a closed space thatcould cause muscle or nerve damage, Stenosis narrowing of a blood vessel(artery), Mitral valve regurgitation blood leakingbackward through the valve between the leftlower chamber of the heart to the left upperchamber of the heart, Hypotension or hypertension low or highblood pressure, Bowel ischemia decreased blood supply tothe intestines. Epub 2017 Oct 27. Pibarot P, Dumesnil JG. Update my browser now. 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. With an updated browser, you will have a better Medtronic website experience. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. 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. Up to 80% deployment. Please select your region. Access instructions for use and other technical manuals in the Medtronic Manual Library. Cardiovascular Cardiovascular 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Your use of the other site is subject to the terms of use and privacy statement on that site. 2010; 121:2123-2129. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US Healthcare Professionals With an abnormal growth in the heart or arteries, Whose failing valve is too small or too big, Whose arteries are too small for the device, Whose arteries that deliver blood to the heart maybe blockedby the device, Whose arteries that deliver blood to the heart need tobe treated, Whose arteries that deliver blood to the brain need tobe treated, Who have a reaction to some imaging solutions, cannot take medications that reduce the risk of blood clots, or who have a reaction to somemetals, Who have severe problems with bleeding or bloodclotting, Who have specific types of surgical valves implanted in the pulmonaryvalve, Who have specific types of surgical valves implanted in the mitralvalve, Who have thick heart muscles, making it difficult for the heart to pumpblood, Who have thick heart muscles that block the heart from pumpingblood, Who need to have a surgical procedure on theiraorta. See how the external tissue wrap on the Evolut PRO TAV performs. Medtronic, www.medtronic.com The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. Recapture and reposition Select country / region and language . Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Language Remember My Preferences. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. November 2016;18(11):67. 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 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 <17 mm or >30 mm; 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. 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. Broadest annulus range based on CT-derived diameters. Cardiovascular TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Home Access instructions for use and other technical manuals in the Medtronic Manual Library. Treatments & Therapies Transcatheter Aortic Heart Valves During the procedure, monitor contrast media usage. Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. 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. Cardiovascular Broadest annulus range* All other brands are trademarks of a Medtronic company. 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 . 4588 0 obj <>stream Less information (see less). In addition, patient age should be considered as long-term durability of the valve has not been established. $G` Prosthesis-patient mismatch: definition, clinical impact, and prevention. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Meet the Evolut R System. Transcatheter Aortic Heart Valves Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Keep appointments with your doctor. If you continue, you may go to a site run by someone else. Damage may result from forceful handling of the catheter. It is possible that some of the products on the other site are not approved in your region or country. The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. August 2006;92(8);1022-1029. Access instructions for use and other technical manuals in the Medtronic Manual Library. 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 Less information (see less). %PDF-1.5 % Flameng, W, et al. 2020 Medtronic. It is possible that some of the products on the other site are not approved in your region or country. Access instructions for use and other technical manuals in the Medtronic Manual Library. United States of America * Country / Region. Home Products See how the external tissue wrap on the Evolut PRO TAVI performs. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule.
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medtronic evolut pro valve mri safety