medtronic evolut pro valve mri safety

Up to 80% deployment. J Am Coll Cardiol. Please talk to your doctor to decide whether this therapy is right for you. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. Healthcare Professionals Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . 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. endstream endobj 4545 0 obj <. You may also call800-961-9055 for a copy of a manual. November 2016;18(11):67. Skip to main content English The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. Access instructions for use and other technical manuals in the Medtronic Manual Library. For applicable products, consult instructions for use on manuals.medtronic.com. 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). Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US 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. 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. 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. In addition, patient age should be considered as long-term durability of the valve has not been established. Circulation. 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. PDF View Shellock R & D Services, Inc. email: . . Home per pulse sequence) in 1.5-Tesla and 3-Tesla MR systems, using an MR system reported, whole body averaged SAR of 2-W/kg or less, as follows: Highest temperature changes 2023 Medtronic . Pibarot P, Dumesnil JG. Search by the product name (e.g., Evolut) or model number. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. Lowest delivery profile During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Click OK to confirm you are a Healthcare Professional. General Clinical long-term durability has not been established for the bioprosthesis. `)\;>! Healthcare Professionals Evolut FX * Third party brands are trademarks of their respective owners. Access instructions for use and other technical manuals in the Medtronic Manual Library. All other brands are trademarks of a Medtronic company. Prevent kinking of the catheter when removing it from the packaging. Up to 80% deployment. Or, you may contact technical support online. 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% Cardiovascular Bleiziffer S, Eichinger WB, Hettich I, et al. 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. Find more detailed TAVRinformation, educationalresources, and tools. Evolut FX system enhancements make TAVR procedures easier to visualize and more predictable. Products endstream endobj startxref 2020 Medtronic. Explore our valve design and theperformance of the Evolut platform over time. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Access instructions for use and other technical manuals in the Medtronic Manual Library. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Evolut PRO System Sealing + Performance Home Search by the product name (e.g., Evolut) or model number. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Curr Treat Options Cardiovasc Med. 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. See how the external tissue wrap on the Evolut PRO TAVI performs. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Indications, Safety, & Warnings. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Follow all care instructions to ensure the best possible results. Proper sizing of the devices is the responsibility of the physician. 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. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. 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). Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Find additional feature information, educational resources, and tools. Bitte whlen Sie Ihre Region. 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. PRODUCT DETAILS EXCEPTIONAL DESIGN With an updated browser, you will have a better Medtronic website experience. Transcatheter Aortic Heart Valves For best results, use Adobe Acrobat Reader with the browser. 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. November 1, 1999;34(5):1609-1617. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. August 2006;92(8);1022-1029. Products $/R$J101 0 See the Evolut R System. Go . Your doctor can let you know which risks will most likely apply to you. Heart Valves and Annuloplasty Rings More. Home performance of the Evolut platform over time. Reach out to LifeLine CardioVascular Tech Support with questions. Cardiovascular In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Home Heart. If you continue, you may go to a site run by someone else. Click OK to confirm you are a Healthcare Professional. Evolut FX TAVR/TAVI Deployment Video 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). Broadest annulus range based on CT derived diameters. Update my browser now. Less information (see less). Healthcare Professionals Reach out to LifeLine CardioVascular Tech Support with questions. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Radiopaque gold markers provide a reference for deployment depth and commissure location. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W 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. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Broadest annulus range based onCT-derived diameters. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Language Remember My Preferences. 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 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. With an updated browser, you will have a better Medtronic website experience. For best results, use Adobe Acrobat Reader with the browser. Products 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. The external wrap increases surface contact with native anatomy, providing advanced sealing. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. 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.
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