The external wrap increases surface contact with native anatomy, providing advanced sealing. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. 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. 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. Cardiovascular 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. * Third party brands are trademarks of their respective owners. Home Home 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. Access instructions for use and other technical manuals in the Medtronic Manual Library. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS 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. Update my browser now. Cardiovascular See how the external tissue wrap on the Evolut PRO TAVI performs. Radiopaque gold markers provide a reference for deployment depth and commissure location. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. English. Up to 80% deployment. Search by the product name (e.g., Evolut) or model number. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Indications, Safety, & Warnings. 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. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Transcatheter Aortic Heart Valves. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Cardiovascular Meet the Evolut R System. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. 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. Transcatheter Aortic Heart Valves Heart. Recapture and reposition If you continue, you may go to a site run by someone else. Update my browser now. This study is a prospective, single arm, multi-center . MRI Resources, For clinicians whose patients have a Medtronic system. t X For applicable products, consult instructions for use on manuals.medtronic.com. Click OK to confirm you are a Healthcare Professional. Products 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. Heart. See the Evolut R System. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. With an updated browser, you will have a better Medtronic website experience. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Products All other brands are trademarks of a Medtronic company. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Your use of the other site is subject to the terms of use and privacy statement on that site. Less information (see less). Cardiovascular 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. All other brands are trademarks of a Medtronic company. Home If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Broadest annulus range* With an updated browser, you will have a better Medtronic website experience. Refer to the Instructions for Use for available sizes. Heart. January 2016;102(2):107-113. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. 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. The EnVeo PRO delivery system assists in accurate positioning of the valve. With an updated browser, you will have a better Medtronic website experience. See how the external tissue wrap on the Evolut PRO TAV performs. 2020 Medtronic. 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. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Broadest annulus range based on CT-derived diameters. Update my browser now. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Your doctor can let you know which risks will most likely apply to you. Explore our valve design and theperformance of the Evolut platform over time. In addition, patient age should be considered as long-term durability of the valve has not been established. The EnVeo PRO delivery system assists in accurate positioning of the valve. 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. 4544 0 obj <> endobj 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. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Update my browser now. 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. J Am Coll Cardiol. Update my browser now. Access instructions for use and other technical manuals in the Medtronic Manual Library. `)\;>! Evolut FX TAVR/TAVI Deployment Video United States of America * Country / Region. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Cardiovascular For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Products Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Transcatheter aortic valve replacement (TAVR), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Cardiogenic shock failure of the heart topump enough blood to the body organs, Cardiac tamponade the constriction orinability of the heart to pump due to buildup ofblood or fluidaround the lining of the heart, Perforation of the myocardium or vessel ahole in the heart muscle or a blood vessel, Partial or complete block of coronary artery(that supplies blood to the heart), Ascending aorta trauma injury to the largeblood vessel leading blood away from the heart, Additional cardiac surgery, vascular surgery, orintervention, including removal of the TAV. More information (see more) Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Important Safety Information. If you continue, you may go to a site run by someone else. Treatments & Therapies Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Selecione a sua regio. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. 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. 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. PRODUCT DETAILS EXCEPTIONAL DESIGN For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. With an updated browser, you will have a better Medtronic website experience. For best results, use Adobe Acrobat Reader with the browser. August 2006;92(8);1022-1029. The external wrap increases surface contact with native anatomy, providing advanced sealing. . 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% Reach out to LifeLine CardioVascular Tech Support with questions. Find more detailed TAVRinformation, educationalresources, and tools. 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. Update my browser now. Raise your expectations for what is possiblewith the Evolut FX system. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. 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 Click OK to confirm you are a Healthcare Professional. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name 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. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR), 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. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Manuals can be viewed using a current version of any major internet browser. Click OK to confirm you are a Healthcare Professional. Products With an updated browser, you will have a better Medtronic website experience. These legacy and new design features provide the following sealing mechanisms: The Evolut TAVR platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. 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. 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. Products Evolut PRO System Sealing + Performance AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Prosthesis-patient mismatch: definition, clinical impact, and prevention. * Third party brands are trademarks of their respective owners. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Follow all care instructions to ensure the best possible results. $/R$J101 $G` Smooth, controlled, precise, and predictable. Proper sizing of the devices is the responsibility of the physician. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. Indications, Safety, and Warnings Product Details 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Update my browser now. Less information (see less). Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Go . For best results, use Adobe Acrobat Reader with the browser. Less information (see less). If you continue, you may go to a site run by someone else. Pibarot P, Dumesnil JG. 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. - (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. Epub 2017 Oct 27. 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 Healthcare Professionals Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. Up to 80% deployment. November 1, 1999;34(5):1609-1617. Radiopaque gold markers provide a reference for deployment depth and commissure location. Home Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Language Remember My Preferences. Object Category Heart Valves and Annuloplasty Rings. 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 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. Find more detailed TAVRinformation, educationalresources, and tools. Flameng, W, et al. Evolut PRO System Sealing + Performance
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