THE List - MRI Safety Find additional feature information, educational resources, and tools. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . With an updated browser, you will have a better Medtronic website experience.
Healthcare Professionals Evolut PRO. Find more detailed TAVRinformation, educationalresources, and tools. Medtronic, www.medtronic.com
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Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . Products See how the external tissue wrap on the Evolut PRO TAV performs.
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.
Healthcare Professionals Re-engineered delivery system expands flexibility for360 range of motion and increases conformability to the anatomy for a 50% reduction in tracking forces*1 in challenging anatomies. Products
Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve.
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More information (see more) For best results, use Adobe Acrobat Reader with the browser. 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.
AccessGUDID - DEVICE: Evolut PRO+ (00763000211127)
The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below.
Medtronic Evolut TAVR System Shows Strong Performance at Two Years in Flameng, W, et al. 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% MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS 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 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.
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The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. Evaluate bioprosthesis performance as needed during patient follow-up. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. MRI safety information | Edwards Lifesciences
Proper sizing of the devices is the responsibility of the physician. PRODUCT DETAILS EXCEPTIONAL DESIGN PDF Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Less information (see less). Healthcare Professionals Indications, Safety, and Warnings Product Details
Raise your expectations for what is possiblewith the Evolut FX system. Search by the product name (e.g., Evolut) or model number. 2023 Medtronic . Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic 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).
For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft.
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. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name
In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure.
Curr Treat Options Cardiovasc Med. For applicable products, consult instructions for use on manuals.medtronic.com. Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic Search by the product name (e.g., Evolut) or model number. Avoid prolonged or repeated exposure to the vapors. 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.
Click OK to confirm you are a Healthcare Professional. Manuals can be viewed using a current version of any major internet browser. PDF View Shellock R & D Services, Inc. email: . Cardiovascular $/R$J101 Up to 80% deployment.
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.
Cardiovascular If you continue, you may go to a site run by someone else.
Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve Evolut PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR). With an updated browser, you will have a better Medtronic website experience. 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. 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. Pibarot P, Dumesnil JG. Keep appointments with your doctor. 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. J Am Coll Cardiol.
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. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Update my browser now. 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. Bitte whlen Sie Ihre Region. performance of the Evolut platform over time. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure.
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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. Transcatheter Aortic Heart Valves - Evolut R | Medtronic
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Prosthesis-patient mismatch: definition, clinical impact, and prevention. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement.
With an updated browser, you will have a better Medtronic website experience. Evolut FX
The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Treatments & Therapies Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Products Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 2010; 121:2123-2129.
Products Lowest delivery profile
Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes.
The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). The Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap on all valve sizes.
MRI Resources, For clinicians whose patients have a Medtronic system.
2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5,
l@ !W During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Object Info: - MRI Safety Evolut PRO System Sealing + Performance
Important Safety Information. Update my browser now. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Medtronic MRI Verify allows you to look up the MR conditionality of a patient's Medtronic cardiac implantable electronic device based on the information available. Less information (see less). 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 Reach out to LifeLine CardioVascular Tech Supportwith questions. Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment Healthcare Professionals
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Heart Valves and Annuloplasty Rings More.
Broadest annulus range*
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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.
For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Transcatheter Aortic Heart Valves Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. What is a Medtronic 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.
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. Safety Topic / Subject Heart Valves and Annuloplasty Rings. endstream
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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. The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. hbbd``b`kS`o%@y)x Recapture and reposition
If 2 of these factors are present, consider an alternative access route to prevent vascular complications. From CoreValve to Evolut PRO: Reviewing the Journey of Self - PubMed
* Third party brands are trademarks of their respective owners. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Update my browser now. Access instructions for use and other technical manuals in the Medtronic Manual Library.
The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. November 2016;18(11):67. Broadest annulus range*
Evolut PRO+ Transcatheter Aortic Valve | Medtronic Less information (see less).
AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Object Info: - MRI Safety Your dentist and all doctors need to know about your Medtronic TAVR valve. Home Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Transcatheter Aortic Heart Valves Indications, Safety, & Warnings. 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.
hb```lu eah(x B Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. The safety and efficacy of Medtronic's CoreValve system has been evaluated in more than a dozen clinical trials, including Medtronic's CoreValve U.S. Pivotal Trial (1,389 subjects followed for five years) and the SURTAVI trial (1,660 subjects followed for two years with a plan for ten-year follow-up).
Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Update my browser now.
The bioprosthesis size must be appropriate to fit the patients anatomy. Evolut PRO+ - Transcatheter Aortic Heart Valves | Medtronic AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience For best results, use Adobe Acrobat Reader with the browser.
Damage may result from forceful handling of the catheter. Search by the product name (e.g., Evolut) or model number. 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). The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Smooth, controlled, precise, and predictable.
Home Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR).
Heart. All other brands are trademarks of a Medtronic company.
THE List - MRI Safety
These legacy and new design features provide the following sealing mechanisms: The Evolut TAVR platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients.
See how the external tissue wrap on the Evolut PRO TAV performs. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name.
CoreValve and Evolut TAVR Systems | Medtronic Find more detailed TAVRinformation, educationalresources, and tools.
Or, you may contact technical support online. 3: Conditional 5 More.
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