medtronic evolut pro valve mri safety

Access instructions for use and other technical manuals in the Medtronic Manual Library. Reach out to LifeLine CardioVascular Tech Support with questions. 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. Third attempt must be a complete recapture and retrieval from patient. The EnVeo PRO delivery system assists in accurate positioning of the valve. Your use of the other site is subject to the terms of use and privacy statement on that site. Healthcare Professionals 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. 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. All other brands are trademarks of a Medtronic company. Conduct the procedure under fluoroscopy. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: August 2006;92(8);1022-1029. Healthcare Professionals United States of America * Country / Region. Update my browser now. Flameng, W, et al. During the procedure, monitor contrast media usage. For best results, use Adobe Acrobat Reader with the browser. 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% Circulation. For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Search by the product name (e.g., Evolut) or model number. 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 Products 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. If you continue, you may go to a site run by someone else. See how the external tissue wrap on the Evolut PRO TAVI performs. 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. It is possible that some of the products on the other site are not approved in your region or country. Healthcare Professionals Bitte whlen Sie Ihre Region. endstream endobj startxref If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Bench testing may not be indicative of clinical performance. 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. You may also call 800-961-9055for a copy of a manual. Radiopaque gold markers provide a reference for deployment depth and commissure location. With an updated browser, you will have a better Medtronic website experience. Language Remember My Preferences. Transcatheter Aortic Heart Valves 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. All other brands are trademarks of a Medtronic company. * Third party brands are trademarks of their respective owners. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Cardiovascular 2023 Medtronic . More information (see more) 2010; 121:2123-2129. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Products More information (see more) The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. 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. 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. Please select your region. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. 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. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Cardiovascular More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. 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. 4588 0 obj <>stream 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 . Update my browser now. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Cardiovascular Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Click OK to confirm you are a Healthcare Professional. Epub 2017 Oct 27. * Third party brands are trademarks of their respective owners. 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. 2020 Medtronic. Products 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). If you continue, you may go to a site run by someone else. Evolut FX system enhancements make TAVR procedures easier to visualize and more predictable. See the Evolut R System. Access instructions for use and other technical manuals in the Medtronic Manual Library. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Your use of the other site is subject to the terms of use and privacy statement on that site. Access instructions for use and other technical manuals in the Medtronic Manual Library. Up to 80% deployment. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. 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 content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. Or, you may contact technical support online. %PDF-1.5 % Broadest annulus range based on CT derived diameters. Healthcare Professionals Your dentist and all doctors need to know about your Medtronic TAVR valve. hbbd``b`kS`o%@y)x Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. With an updated browser, you will have a better Medtronic website experience. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). For applicable products, consult instructions for use on manuals.medtronic.com. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and hasthe ability to treat the broadest annulus range* of any commercially available TAVR system. This study is a prospective, single arm, multi-center . Go . performance of the Evolut platform over time. The EnVeo PRO delivery system assists in accurate positioning of the valve. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Less information (see less). 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. 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. Prevent kinking of the catheter when removing it from the packaging. Less information (see less). AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Transcatheter Aortic Heart Valves Cardiovascular 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. Home August 2006;92(8);1022-1029. 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Reach out to LifeLine CardioVascular Tech Support with questions. 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. T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s Manuals can be viewed using a current version of any major internet browser. Update my browser now. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Less information (see less). PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . Update my browser now. Home Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. The external wrap increases surface contact with native anatomy, providing advanced sealing. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. The safety and efficacy of Medtronic's CoreValve system has been evaluated in more than a dozen clinical trials, including Medtronic's CoreValve U.S. Pivotal Trial (1,389 subjects followed for five years) and the SURTAVI trial (1,660 subjects followed for two years with a plan for ten-year follow-up). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Circulation. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. 0 Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Home 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. You may also call800-961-9055 for a copy of a manual. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. 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. Update my browser now. With an updated browser, you will have a better Medtronic website experience. Prior to the procedure, measure the patients creatinine level. 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. Lowest delivery profile 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). Home Update my browser now. Evolut FX Treatments & Therapies Skip to main content English Heart Valves and Annuloplasty Rings More. 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. 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. Evolut FX TAVR/TAVI Deployment Video

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