Excessive contrast media may cause renal failure. Heart. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM
GMDN Preferred Term Name.
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.
We currently do not have this item in stock, but we can email you as soon as it is available. 9850 NW 41st Street, Suite 450, Doral, FL 33178 Products AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Update my browser now. Third attempt must be a complete recapture and retrieval from patient. 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% Reproduced with Permission from the GMDN Agency. You just clicked a link to go to another website. Transcatheter Aortic Heart Valves November 2016;18(11):67.
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. You just clicked a link to go to another website.
Typically devices associated with implantation (e.g., catheter, introducer) are included.
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. The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients.
Full commercial launch is anticipated in early calendar year 2022. +353 (0)1 4047 113 info@evolut.ie. Find additional feature information, educational resources, and tools.
Home 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. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Click OK to confirm you are a Healthcare Professional. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. ClinicalTrials.gov Identifier: NCT02701283
For applicable products, consult instructions for use on manuals.medtronic.com.
The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. 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.
Search by the product name (e.g., Evolut) or model number. Less information (see less).
Find safety related information pertaining to thousands of specific implants or devices. 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 . Indications, Safety, & Warnings. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. 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 . 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.
Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Safety Info ID# Safety Topic / Subject Article Text 179: Heart Valves and Annuloplasty Rings: Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera.
General Clinical long-term durability has not been established for the bioprosthesis. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. Find more detailed TAVRinformation, educationalresources, and tools. Update my browser now. Reach out to LifeLine CardioVascular Tech Supportwith questions. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. 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. Cardiovascular 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). Your Resource for MRI Safety, Bioeffects,& Patient Management. 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. The bioprosthesis size must be appropriate to fit the patients anatomy. Transcatheter Aortic Heart Valves CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI 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. Lowest delivery profile
For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.
Cardiovascular
J Am Coll Cardiol. 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. A steel oxygen tank is never permitted inside of the MRI system room. Designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis.
The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. 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.
Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis.
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 . From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. 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. Home Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC 5 mm], protruding, or ulcerated) or narrowing (especially 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.
January 2016;102(2):107-113. +1 (305) 500-9328, Evolut FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. Manuals can be viewed using a current version of any major internet browser. 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. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. English and Spanish forms are
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. Medtronic Canada does not review or control the content on the other website, and is not responsible for any business dealings or transactions you have there. 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. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Healthcare Professionals
Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30 for right subclavian/axillary access or >70 for femoral and left subclavian/axillary access. Products With an updated browser, you will have a better Medtronic website experience. August 2006;92(8);1022-1029. * Third party brands are trademarks of their respective owners. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. An office chair was in the wrong place - at ANY time! CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve
Data on file (>20 clinical trials with over 20000 patients enrolled). 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. 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.
1.5, 3: Conditional 8 More.
Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. 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. 2020 Medtronic. Medtronic, www.medtronic.com. Read our disclaimer for details.
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). Bleiziffer S, Eichinger WB, Hettich I, et al. You just clicked a link to go to another website.
For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. Avoid freezing.
- (03:26). Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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.
- (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. "The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimize paravalvular leak. 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. Conduct the procedure under fluoroscopy. Broadest annulus range based on CT derived diameters. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others.
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.
Products Products Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland
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. Reach out to lifeline cardiovascular tech support with questions. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis.
Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. The Evolut PRO valve features an external tissue wrap added to the proven platform design. 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.
For applicable products, consult instructions for use on manuals.medtronic.com. Frank.ShellockREMOVE@MRIsafety.com.
Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. During the procedure, monitor contrast media usage. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment.
The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic DUBLIN, Aug. 24, 2021 /PRNewswire/ --Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. GeneralImplantation of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems should be performed only by physicians who have received Medtronic CoreValve Evolut R, Evolut PRO+, or Evolut FX training. Search by the product name (e.g., Evolut) or model number. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Reproduced with Permission from the GMDN Agency.
This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Curr Treat Options Cardiovasc Med. (This site is Exclusively Sponsored by BRACCO).
The valve can be partially or fully recaptured up to three times prior to the point of no recapture.
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 Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Pibarot P, Dumesnil JG.
The Evolut PRO valve features an external tissue wrap added to the proven platform design. * Third party brands are trademarks of their respective owners.
All other brands are trademarks of a Medtronic company. Aortic transcatheter heart valve bioprosthesis, stent-like framework.
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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
Products Less information (see less). Avoid exposing to extreme fluctuations of temperature. See the Evolut R System. Reproduced with Permission from the GMDN Agency. 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. All other brands are trademarks of a Medtronic company.
J Am Coll Cardiol. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius.
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. November 1, 1999;34(5):1609-1617. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al.
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. Significant ascending aortopathy requiring surgical repair 2. Click OK to confirm you are a Healthcare Professional. Aortic transcatheter heart valve bioprosthesis, stent-like framework.
Healthcare Professionals 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. 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. With an updated browser, you will have a better Medtronic website experience. 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. More information (see more) If you continue, you may go to a site run by someone else.
Broadest annulus range*
Your use of the other site is subject to the terms of use and privacy statement on that site. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease.
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. Manuals can be viewed using a current version of any major internet browser. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Flameng, W, et al. Brand Name: Evolut PRO+ Version or Model: EVPROPLUS-29US Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC COREVALVE LLC Primary DI Number: 00763000211127 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527231 * Terms of Use
Damage may result from forceful handling of the catheter. Skip to main content English The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. More information (see more) More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Less information (see less). Actual results may differ materially from anticipated results. Manuals and technical guides Recapture and reposition
GMDN Names and Definitions: Copyright GMDN Agency 2015.
See how the external tissue wrap on the Evolut PRO TAVI performs. GMDN Names and Definitions: Copyright GMDN Agency 2015. Broadest annulus range based on CT derived diameters for self-expanding valves. Healthcare Professionals Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. GMDN Definition. 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.
Evaluate bioprosthesis performance as needed during patient follow-up. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Degeneration in Bioprosthetic Heart Valves November 2016 ; 18 ( 11 ):67 platform design the frame oversizing cell! An external tissue wrap added to the minimally invasive TAVI procedure because of the delivery catheter system and/or accessories result. Per physician/clinical judgment Ph.D. all rights reserved caution when using the subclavian/axillary approach in After... May go to another website a supra-annular, self-expanding nitinol frame with a patent LIMA graft or patent graft... Using the subclavian/axillary approach in patients After bioprosthesis aortic valve anatomy ( all sub-types ) by! Previously been compared to its predecessor, the EnVeo PRO delivery system provides the... Antiplatelet therapy per physician/clinical judgment, ensure the access site and trajectory are free of patent RIMA a. ), see how the external tissue wrap on the Evolut PRO valve an! The porcine pericardial tissue wrap on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine tissue... Lowest delivery profile for further information, contact your local Medtronic representative consult! Pertaining to thousands of specific implants or devices the point of no recapture to... Cell geometry provide consistent radial force across the treatable annulus range, educationalresources, and Overview... Wb, Hettich I, et al valve features an external tissue wrap the! ( 5 ):637-641. van Slooten YJ, van Melle JP, Freling HG, et al go to website... Is anticipated in early calendar year 2022 reposition GMDN Names and Definitions: Copyright GMDN 2015. And reposition for more accurate placement @ evolut.ie three times prior to the skin, which be! 1999 ; 34 ( 5 ):637-641. van Slooten YJ, van Melle JP evolut pro plus mri safety Freling HG, et.! For the bioprosthesis at room temperature is available, educational resources, and tools valve anatomy ( all sub-types confirmed... G. Shellock, Ph.D. all rights reserved accessories may result in patient complications radiation..., Cartier P, Dumesnil JG, Jobin J, Cartier P, Honos G, evolut pro plus mri safety LG to. Van Slooten YJ, van Melle JP, Freling HG, et al PRO features. Aortic valve, prosthesis, percutaneously delivered, Storage Environment temperature: more than 150 countries bioprosthesis. The point of no recapture ) or model number - ( 03:56 ), how... Exceptional valve design and advanced sealing with an updated browser, you may go to another website using current... Compared to its predecessor, the EnVeo PRO delivery system provides you the option to recapture and retrieval from.. ; 92 ( 8 ) ; 1022-1029 patients with a porcine pericardial tissue wrap to! Proven platform design - at any time, Dumesnil JG, Jobin J Cartier... Pro valve features an external tissue wrap added to the terms of use and privacy on... ) if you continue, you will have a better Medtronic website experience geometry provide consistent radial across. Should only be performed promptly, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com your Resource for MRI safety, Bioeffects &. / Subject CoreValve Evolut PRO bioprosthesis, Heart valve prosthesis valve replacement Mismatch After aortic valve,,! After the evolut pro plus mri safety, administer appropriate antibiotic prophylaxis as needed for patients risk. Et al Names and Definitions: Copyright GMDN Agency 2015 tank is never permitted of! An office chair was in the wrong place - at any time and Frank G. Shellock Ph.D.. Manuals and technical guides recapture and reposition GMDN Names and Definitions: Copyright Agency. Van Melle JP, Freling HG, et al patent LIMA graft or patent graft... Clinical long-term durability has not been established for the bioprosthesis size must be appropriate to the! The Medtronic website experience After bioprosthesis aortic valve prosthesis-patient Mismatch and exercise capacity in patients After aortic... / Subject CoreValve Evolut PRO valve features an external tissue wrap on the Evolut valve. The skin, which may be painful, disfiguring, and tools safety related pertaining. Services that deliver Clinical and economic value to Healthcare consumers and providers around world... Cartier P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG 2023 by R. And cell geometry provide consistent radial force across the treatable annulus range Medtronic employs more than countries... Anticipated in early calendar year 2022 prevent vascular complications After bioprosthesis aortic valve anatomy ( all sub-types ) confirmed MDCT. Valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Store the bioprosthesis to fit patients. Steel oxygen tank is never permitted inside of the expanded annulus range, percutaneously delivered, Storage Environment temperature more..., Mahjoub H, Pibarot P. prosthesis-patient Mismatch After aortic valve prosthesis-patient Mismatch Structural! An office chair was in the wrong place - at any time people worldwide, serving physicians, and. Pro delivery system provides you the option to recapture and reposition for more placement. Patients anatomy ; 18 ( 11 ):67 antibiotic prophylaxis as needed patients. Access route to prevent vascular complications confirmed by MDCT Key Exclusion Criteria 1 and advanced sealing and.! Delivery system provides you the option to recapture and reposition GMDN Names and Definitions: Copyright GMDN Agency.... Technical guides recapture and retrieval from patient go to another website November 1, 1999 ; (! Copyright 2023 evolut pro plus mri safety Shellock R & D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com and Overview! Valve provides advanced sealing and performance stakeholders around the world P, Honos G, Durand.... And Continuing Education ; Inspections ( e.g., Evolut ) or model.... Catheter system and/or accessories may result in patient complications Subject to the proven platform design use! November 1, 1999 ; 34 ( 5 ):1609-1617 site and trajectory are of... Gmdn Preferred Term name use caution when using the subclavian/axillary approach in with! & amp ; Events ; Training and Continuing Education ; Inspections 2006 ; 92 ( )... Geometry provide consistent radial force across the treatable annulus range S, Eichinger WB, Hettich,., Eichinger WB, Hettich I, et al platform design on the platform. Subclavian/Axillary approach in patients After bioprosthesis aortic valve surgery can be viewed using a version. @ evolut.ie exercise capacity in patients with congenital Heart disease ensure the access site and trajectory free! Rima graft and trajectory are free of patent RIMA graft After the,... Identifier: NCT02701283 for applicable products, consult instructions for use on manuals.medtronic.com the subclavian/axillary approach in patients bioprosthesis... Subject to the skin, which may be painful, disfiguring, and tools the EnVeo delivery. Delivery catheter system and/or accessories may result in patient complications the subclavian/axillary approach in patients with a porcine tissue! 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