Evolut PRO+ TAVI System Click OK to confirm you are a Healthcare Professional. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Access instructions for use and other technical manuals in the Medtronic Manual Library. Your use of the other site is subject to the terms of use and privacy statement on that site. Prosthesis-patient mismatch: definition, clinical impact, and prevention. 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. Products Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Less information (see less). 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. Transcatheter Aortic Heart Valves 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. 2020 Medtronic. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Up to 80% deployment. Methods. Search by the product name (e.g., Evolut) or model number. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. MRIsafety.com is Exclusively Sponsored by BRACCO, MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging 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. Broadest annulus range based on CT derived diameters. Update my browser now. Transcatheter Aortic Heart Valves 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 <4.0 m/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. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. GMDN Preferred Term Name. Ascending aorta diameter >4.5 cm 3. Safety Topics ; Home; help (full/part words) . In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Recapture and reposition 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. Download MRI pre-screening forms for patients and MR personnel. Home 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, Evolut PRO+ TAVI System For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. A steel oxygen tank is never permitted inside of the MRI system room. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. 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 Evolut PRO System Sealing + Performance Typically devices associated with implantation (e.g., catheter, introducer) are included. J Am Coll Cardiol. Manual Library Instructions for use and product manuals for healthcare professionals Special Storage Condition, Specify: Store the bioprosthesis at room temperature. 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 <17mm or >30mm; 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 best results, use Adobe Acrobat Reader with the browser. Damage may result from forceful handling of the catheter. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. 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. November 1, 1999;34(5):1609-1617. The Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. 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. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. All other brands are trademarks of a Medtronic company. Your use of the other site is subject to the terms of use and privacy statement on that site. For information, visit MagneticResonanceSafetyTesting.com. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. In addition, patient age should be considered as long-term durability of the valve has not been established. Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve The Evolut PRO system goes beyond the CoreValve and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. Find safety related information pertaining to thousands of specific implants or devices. Broadest annulus range based on CT derived diameters. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Indications, Safety, & Warnings. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. You just clicked a link to go to another website. GMDN Definition. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. During the procedure, monitor contrast media usage. MRIsafety.com is the premier information resource for magnetic resonance safety. You just clicked a link to go to another website. Implanting a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis in a degenerated surgical bioprosthetic valve (transcatheter aortic valve in surgical aortic valve [TAV-in-SAV]) should be avoided in the following conditions: The degenerated surgical bioprosthetic valve presents with: a significant concomitant paravalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g., wire form frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer-labeled inner diameter <17mm. 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. November 1, 1999;34(5):1609-1617. Update my browser now. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland 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 PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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. Class 2 Device Recall CoreValve Evolut PRO PLUS Delivery Catheter System: Date Initiated by Firm: June 11, 2021: Create Date: July 09, 2021: Recall Status 1: Open 3, Classified: Recall Number: Z-2043-2021: Recall Event ID: . Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. You just clicked a link to go to another website. Heart Valves and Annuloplasty Rings More. The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. Limited commercial release is planned for the fall with a full launch anticipated in early 2022. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Manuals can be viewed using a current version of any major internet browser. The fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant. The EnVeo PRO delivery system assists in accurate positioning of the valve. Visit: IMRSER Videos. available. J Am Coll Cardiol. Epub 2017 Oct 27. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 9850 NW 41st Street, Suite 450, Doral, FL 33178 Visit Amazon.com for more information or to order. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Anatomical characteristics should be considered when using the valve in this population. Are trademarks of a large EOA may include: Supra-annular valve design is taking outcomes. 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