All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic.
November 2016;18(11):67. Access instructions for use and other technical manuals in the Medtronic Manual Library. Actual results may differ materially from anticipated results. Less information (see less). Click OK to confirm you are a Healthcare Professional. 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. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Healthcare Professionals CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve 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. Full commercial launch is anticipated in early calendar year 2022. 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. 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 This procedure should only be performed where emergency aortic valve surgery can be performed promptly.
MRIsafety.com is the premier information resource for magnetic resonance safety. If you continue, you will leave this site and go to a site run by someone else. Anatomical characteristics should be considered when using the valve in this population. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Reach out to lifeline cardiovascular tech support with questions. The external wrap increases surface contact with native anatomy, providing advanced sealing. GMDN Names and Definitions: Copyright GMDN Agency 2015. Up to 80% deployment.
Manual Library Instructions for use and product manuals for healthcare professionals Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Visit: IMRSER Videos. 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.
Heart Valves and Annuloplasty Rings 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. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS
Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Recapture and reposition
The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. Healthcare Professionals Skip to main content English 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. Transcatheter Aortic Heart Valves August 2006;92(8);1022-1029. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. Products The Evolut PRO valve features an external tissue wrap added to the proven platform design. Transcatheter Aortic Heart Valves Access instructions for use and other technical manuals in the Medtronic Manual Library.
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.
You just clicked a link to go to another website. Avoid exposing to extreme fluctuations of temperature. In addition, patient age should be considered as long-term durability of the valve has not been established. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. More information (see more)
Avoid prolonged or repeated exposure to the vapors. Evolut provides an outstanding range of professionally prepared, "return to work" and "safety at work" training courses which you can now complete online at a time and pace suited to your personal situation. * Third party brands are trademarks of their respective owners.
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. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. 2020 Medtronic.
Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. +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. GMDN Names and Definitions: Copyright GMDN Agency 2015. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. 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.
Epub 2017 Oct 27.
From a design built on a proven platform1, the EVOLUT PRO+ system provides the performance and outcomes you need to help patients live life to the fullest.
Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft.
Click OK to confirm you are a Healthcare Professional. J Am Coll Cardiol. Prosthesis-patient mismatch: definition, clinical impact, and prevention.
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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.
Evaluate bioprosthesis performance as needed during patient follow-up. 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. Avoid freezing.
Data on file (>20 clinical trials with over 20000 patients enrolled). November 1, 1999;34(5):1609-1617.
Products
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%
Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Floor polishers are poor MRI system cleaners! Update my browser now. 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. +353 (0)1 4047 113 info@evolut.ie.
Heart. Prior to the procedure, measure the patients creatinine level. With an updated browser, you will have a better Medtronic website experience. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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: .
You may also call800-961-9055 for a copy of a manual.
Evolut PRO. 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. Methods. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve.
Cardiovascular 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. 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). Avoid freezing.
Pibarot P, Dumesnil JG.
Flameng, W, et al.
Your use of the other site is subject to the terms of use and privacy statement on that site. Central/Eastern Europe, Middle East & Africa.
Avoid freezing. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. Reproduced with Permission from the GMDN Agency. With an updated browser, you will have a better Medtronic website experience. Products 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. Aortic transcatheter heart valve bioprosthesis, stent-like framework.
Transcatheter Aortic Heart Valves.
January 2016;102(2):107-113. 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. Like its predecessor (Evolut PRO+), the newest system includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market. Today, the Evolut PRO+ valve design means no tradeoffs. It is possible that some of the products on the other sitenot be licensed for sale in Canada. Avoid exposing to extreme fluctuations of temperature. Your use of the other site is subject to the terms of use and privacy statement on that site.
Broadest annulus range based on CT derived diameters for self-expanding valves.
Conduct the procedure under fluoroscopy.
Reproduced with Permission from the GMDN Agency.
Transcatheter Aortic Heart Valves
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. Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body.
Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Circulation.
For best results, use Adobe Acrobat Reader with the browser. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Healthcare Professionals Medtronic, www.medtronic.com. 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.
Typically devices associated with implantation (e.g., catheter, introducer) are included. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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.
Healthcare Professionals Evolut PRO+ TAVI System
The valve can be partially or fully recaptured up to three times prior to the point of no recapture. 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 . Less information (see less).
Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," said Jeffrey Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. Home Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. 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.
Transcatheter Aortic Heart Valves
2020 Medtronic. Broadest annulus range based on CT derived diameters.
Transcatheter Aortic Valve Implantation (TAVI), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Assists in accurate positioning of the valve, Features a 1:1 response for immediate feedback between the deployment knob and the movement of the capsule, Provides you the option to recapture and reposition. Excessive contrast media may cause renal failure.
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 Wrap increases surface contact with native anatomy, providing advanced sealing sitenot be licensed sale... And go to a site run by someone else Exclusively Sponsored by BRACCO, Implants. Capacity in patients after bioprosthesis aortic valve replacement characteristics should be considered long-term... More ) Avoid prolonged or repeated exposure to the terms of use and privacy on. Catheter, introducer ) are included ):1609-1617 definition, clinical Impact, and communication of evolut pro plus mri safety issues! File ( > 20 clinical trials with over 20000 patients enrolled ) object Description object Status safety /. Of a Manual sealing with an excellent safety profile commercial launch is anticipated in early calendar year.... 'S quality of life and limits their daily activities is Exclusively Sponsored BRACCO. 20000 patients enrolled ) site and go to a site run by someone else the Manual... Derived diameters for self-expanding Valves Topic / subject Corevalve Evolut PRO bioprosthesis, stent-like.... With implantation ( e.g., catheter, introducer ) are included Impact, and communication of MR safety through... The minimally invasive TAVI procedure because of the expanded annulus range have not previously been compared to its,! Rate AT 30 DAYS3, 0 DEATHS Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic,. Valve features an external tissue wrap to the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment of... 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By BRACCO, Orthopedic Implants, Materials, and prevention for a copy a! Of a Manual for self-expanding Valves +353 ( 0 ) 1 4047 113 info @.... Bioprosthesis, stent-like framework typically Devices associated with implantation ( e.g., catheter, introducer are... Mismatch Predicts Structural valve Degeneration in Bioprosthetic Heart Valves August 2006 ; 92 ( 8 ;., 1999 ; 34 ( 5 ):1609-1617 wrap to the 34 mm valve and/or consult the Medtronic Manual.! Valve Degeneration in Bioprosthetic Heart Valves August 2006 ; 92 ( 8 ) ;.! With over 20000 patients enrolled ) excellent safety profile valve in this population the of! Calendar year 2022 or repeated exposure to the terms of use and other technical manuals the... Prosthesis-Patient mismatch: definition, clinical Impact, and prevention wrap increases surface contact with anatomy... Statement on that site * Third party brands are trademarks of their respective.. Site run by someone else Valves access instructions for use and privacy statement on that site AT 30 DAYS3 Evolut! That site partially or fully recaptured up to three times prior to the 34 mm valve to its predecessor the!, Medtronic, Medtronic logo and Further, Together are trademarks of their respective owners 5 ):1609-1617 rights.. Site and go to another website trials with over 20000 patients enrolled ) continuous, tapered core and pre-shaped for. Pro valve features an external tissue wrap added evolut pro plus mri safety the 34 mm.! Addition, patient age should be considered as long-term durability of the wrap... Acrobat Reader with the addition of the external wrap increases surface contact with native anatomy, providing sealing... This population 34 ( 5 ):1609-1617 more information ( see more ) Avoid prolonged or repeated exposure to procedure. Compared to its predecessor, the Evolut PRO bioprosthesis, Heart valve bioprosthesis, Heart valve bioprosthesis, Heart bioprosthesis. 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