Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 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. Up to 80% deployment. This could make you feel sick or cause death. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Update my browser now. Access instructions for use and other technical manuals in the Medtronic Manual Library. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Important Safety Information. If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. 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. Search by the product name (e.g., Evolut) or model number. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. PRODUCT DETAILS EXCEPTIONAL DESIGN Recapture and reposition Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Less information (see less). Prior to the procedure, measure the patients creatinine level. Search by the product name (e.g., Evolut) or model number. Pibarot P, Dumesnil JG. Up to 80% deployment. 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 It is possible that some of the products on the other site are not approved in your region or country. Evolut PRO. Access instructions for use and other technical manuals in the Medtronic Manual Library. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. 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). The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. 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. Cardiovascular Anatomical characteristics should be considered when using the valve in this population. Broadest annulus range based on CT derived diameters. Selezionare la propria regione. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. Bitte whlen Sie Ihre Region. 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. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. 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. 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. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Manuals can be viewed using a current version of any major internet browser. 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. Transcatheter Aortic Heart Valves If you continue, you may go to a site run by someone else. Reach out to LifeLine CardioVascular Tech Support with questions. Click OK to confirm you are a Healthcare Professional. Safety Topic / Subject Heart Valves and Annuloplasty Rings. Select country / region and language . 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 You just clicked a link to go to another website. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Click OK to confirm you are a Healthcare Professional. Products 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. If you continue, you may go to a site run by someone else. Home All other brands are trademarks of a Medtronic company. 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 Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. For applicable products, consult instructions for use on manuals.medtronic.com. During the procedure, monitor contrast media usage. 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 . The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. Your use of the other site is subject to the terms of use and privacy statement on that site. With an updated browser, you will have a better Medtronic website experience. November 1, 1999;34(5):1609-1617. 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. More information (see more) How long it lasts varies from patient to patient. 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. 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. 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. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Home AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience 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. Lowest delivery profile The Evolut PRO valve features an external tissue wrap added to the proven platform design. Prevent kinking of the catheter when removing it from the packaging. Medtronic, www.medtronic.com. Treatments & Therapies Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Healthcare Professionals Circulation. Healthcare Professionals Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. 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. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Cardiovascular Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. $G` Reach out to LifeLine CardioVascular Tech Supportwith questions. Manuals and technical guides Seleccione su regin. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 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. Third attempt must be a complete recapture and retrieval from patient. Manuals can be viewed using a current version of any major internet browser. Reach out to LifeLine CardioVascular Tech Support with questions. Your doctor can let you know which risks will most likely apply to you. 0 Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Meet the Evolut R System. * Third party brands are trademarks of their respective owners. See how the external tissue wrap on the Evolut PRO TAVI performs. 2020 Medtronic. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Broadest annulus range based on CT-derived diameters. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 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. January 2016;102(2):107-113. Refer to the Instructions for Use for available sizes. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. August 2006;92(8);1022-1029. 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. 4588 0 obj <>stream 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. Radiopaque gold markers provide a reference for deployment depth and commissure location. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Heart Valves and Annuloplasty Rings More. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Less information (see less). More information (see more) Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. With an updated browser, you will have a better Medtronic website experience. 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. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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. With an updated browser, you will have a better Medtronic website experience. 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. Evolut FX system enhancements make TAVR procedures easier to visualize and more predictable. Products 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.
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