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. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Home 2020 Medtronic. This could make you feel sick or cause death. 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Update my browser now. Safety Topic / Subject Heart Valves and Annuloplasty Rings. 0 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. Access instructions for use and other technical manuals in the Medtronic Manual Library. We are here for you. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. 4564 0 obj <>/Filter/FlateDecode/ID[<2C0E24D68A9BFB4295F1AF0A6EE224DC>]/Index[4544 45]/Info 4543 0 R/Length 94/Prev 676184/Root 4545 0 R/Size 4589/Type/XRef/W[1 2 1]>>stream Broadest annulus range based onCT-derived diameters. Unfavorable reaction by the body (allergicreaction) to: Antiplatelet agents blood-thinningmedicines that keep blood clots from forming, Contrast medium a substance used toincrease the visualization of body structuressuch as X-ray dye. Find more detailed TAVRinformation, educationalresources, and tools. Lowest delivery profile The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. More information (see more) 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% Recapture and reposition Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. More information (see more) AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Healthcare Professionals Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name Transcatheter Aortic Heart Valves. November 2016;18(11):67. 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. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US 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. You just clicked a link to go to another website. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Broadest annulus range* You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Explore our valve design and theperformance of the Evolut platform over time. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Seleccione su regin. October 14, 2020 Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). Evolut FX TAVR/TAVI Deployment Video For applicable products, consult instructions for use on manuals.medtronic.com. It is possible that some of the products on the other site are not approved in your region or country. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. Patients who do not are more likely to have a stroke. Broadest annulus range based on CT derived diameters. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Object Status Conditional 8. More information (see more) The valve can be partially or fully recaptured up to three times prior to the point of no recapture. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. hbbd``b`kS`o%@y)x You just clicked a link to go to another website. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . If you continue, you may go to a site run by someone else. 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 CoreValve Evolut PRO System, and the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System. You may also call 800-961-9055 for a copy of a manual. 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. Medtronic, www.medtronic.com. * Third party brands are trademarks of their respective owners. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. * Third party brands are trademarks of their respective owners. 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. At some point, the Medtronic TAVR valve may need tobe replaced. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. Patients 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. Less information (see less). Re-engineered delivery system expands flexibility for360 range of motion and increases conformability to the anatomy for a 50% reduction in tracking forces*1 in challenging anatomies. Selecione a sua regio. 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. X'AD`4.$ 2 Your use of the other site is subject to the terms of use and privacy statement on that site. including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Raise your expectations for what is possiblewith the Evolut FX system. 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. The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. Broadest annulus range based on CT-derived diameters. Cardiovascular Broadest annulus range based on CT derived diameters. 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. Bench testing may not be indicative of clinical performance. Update my browser now. Search by the product name (e.g., Evolut) or model number. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. 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. 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. Cardiovascular Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. . Home Curr Treat Options Cardiovasc Med. United States of America * Country / Region. Circulation. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Heart Valves and Annuloplasty Rings More. Evolut PRO. performance of the Evolut platform over time. endstream endobj 4545 0 obj <. 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. 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. All other brands are trademarks of a Medtronic company. For best results, use Adobe Acrobat Reader with the browser. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. For best results, use Adobe Acrobat Reader with the browser. Damage may result from forceful handling of the catheter. Up to 80% deployment. Select country / region and language . Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. See how the external tissue wrap on the Evolut PRO TAVI performs. Evolut PRO. Proper sizing of the devices is the responsibility of the physician. Evolut PRO+. J Am Coll Cardiol. You just clicked a link to go to another website. 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). All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic.

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