See the Evolut R System. Typically devices associated with implantation (e.g., catheter, introducer) are included. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Avoid freezing. Click OK to confirm you are a Healthcare Professional. 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). Device Dimensions Operating and Storage Conditions Device Identifiers FDA Pre-market Approvals/Notifications & deNovo Premarket Approval: P130021 FDA Product Code NPT Aortic valve, prosthesis, percutaneously delivered Sterilization Device Entry Metadata On-Brand Devices [Evolut PRO+] Trademark Results [Evolut] 2022 FDA.report 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. Healthcare Professionals 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. It provides the lowest delivery profile and added surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. 1.5, 3: Conditional 8 More. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency. Your use of the other site is subject to the terms of use and privacy statement on that site. 2010; 121:2123-2129. Prevent kinking of the catheter when removing it from the packaging.
Reproduced with Permission from the GMDN Agency. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Visit: IMRSER.org, Videos Available on IMRSER include: MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. You just clicked a link to go to another website. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Pibarot P, Dumesnil JG. 4 Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery. With an updated browser, you will have a better Medtronic website experience.
A steel oxygen tank is never permitted inside of the MRI system room. It is possible that some of the products on the other sitenot be licensed for sale in Canada. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. Search by the product name (e.g., Evolut) or model number. Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Recapture and reposition
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.
Age <60 years Subject Evaluation 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. Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. Flameng, W, et al. 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. Typically devices associated with implantation (e.g., catheter, introducer) are included. More information (see more)
Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis.
These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years. Less information (see less). TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 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.
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.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Find additional feature information, educational resources, and tools. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Products The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Frank.ShellockREMOVE@MRIsafety.com. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. With an updated browser, you will have a better Medtronic website experience. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. For best results, use Adobe Acrobat Reader with the browser. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Your Resource for MRI Safety, Bioeffects,& Patient Management. It is possible that some of the products on the other site are not approved in your region or country.
Click OK to confirm you are a Healthcare Professional. Avoid freezing. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range.
For information, visit MagneticResonanceSafetyTesting.com. Update my browser now. Broadest annulus range based on CT derived diameters. 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. Medtronic, www.medtronic.com.
Circulation.
Broadest annulus range based on CT derived diameters. Healthcare Professionals More information (see more) Epub 2017 Oct 27. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Less information (see less).
GMDN Preferred Term Name GMDN Definition; Aortic transcatheter heart valve bioprosthesis, stent-like framework An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral .
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. Evolut PRO+ The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. You just clicked a link to go to another website. Aortic transcatheter heart valve bioprosthesis, stent-like framework. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis.
Visit Amazon.com for more information or to order. Manuals and technical guides Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. The external wrap increases surface contact with native anatomy, providing advanced sealing. * Third party brands are trademarks of their respective owners.
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. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services.
Skip to main content English If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.
These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing.
As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow).
The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market.
MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. 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: . Home
With an updated browser, you will have a better Medtronic website experience. Access instructions for use and other technical manuals in the Medtronic Manual Library. Bleiziffer S, Eichinger WB, Hettich I, et al. If you continue, you may go to a site run by someone else. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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.
- (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. It is possible that some of the products on the other site are not approved in your region or country.
Third attempt must be a complete recapture and retrieval from patient. document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Products Bleiziffer S, Eichinger WB, Hettich I, et al.
for all valve sizes with the addition of the external tissue wrap to the 34 mm valve.
January 2016;102(2):107-113. For applicable products, consult instructions for use on manuals.medtronic.com. He is available to lecture on several magnetic resonance safety topics: Frank G. Shellock, Ph.D. is a physiologist with more than 30 years of experience conducting laboratory and clinical investigations in the field of magnetic resonance imaging. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings.
The bioprosthesis size must be appropriate to fit the patients anatomy. Broadest annulus range based on CT derived diameters. 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. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted .
Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft.
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. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Lowest delivery profile
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