PRODUCT DETAILS EXCEPTIONAL DESIGN
Transcatheter Aortic Heart Valves
1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM 4544 0 obj
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Prevent kinking of the catheter when removing it from the packaging. Reach out to LifeLine CardioVascular Tech Supportwith questions. Circulation.
The external wrap increases surface contact with native anatomy, providing advanced sealing. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Transcatheter aortic valve replacement (TAVR), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Cardiogenic shock failure of the heart topump enough blood to the body organs, Cardiac tamponade the constriction orinability of the heart to pump due to buildup ofblood or fluidaround the lining of the heart, Perforation of the myocardium or vessel ahole in the heart muscle or a blood vessel, Partial or complete block of coronary artery(that supplies blood to the heart), Ascending aorta trauma injury to the largeblood vessel leading blood away from the heart, Additional cardiac surgery, vascular surgery, orintervention, including removal of the TAV. Transcatheter Aortic Heart Valves | Medtronic Raise your expectations for what is possiblewith the Evolut FX system. Click OK to confirm you are a Healthcare Professional. Lowest delivery profile
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.
2020 Medtronic. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. Broadest annulus range*
August 2006;92(8);1022-1029. Radiopaque gold markers provide a reference for deployment depth and commissure location.
Pibarot P, Dumesnil JG. Proper sizing of the devices is the responsibility of the physician.
Language Remember My Preferences. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat.
Healthcare Professionals Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately.
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For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Healthcare Professionals If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve.
CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI
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November 2016;18(11):67.
You just clicked a link to go to another website. 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. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Update my browser now. We are here for you.
Radiopaque gold markers provide a reference for deployment depth and commissure location.
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 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.
Broadest annulus range based onCT-derived diameters. Find more detailed TAVRinformation, educationalresources, and tools. 4588 0 obj
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The Evolut PRO+ system offers the lowest delivery profile for 2329 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealingwith an external tissue wrap on all valve sizes.
If you continue, you may go to a site run by someone else. 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. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement.
Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus.
Evolut PRO System Sealing + Performance Curr Treat Options Cardiovasc Med. $/R$J101 Search by the product name (e.g., Evolut) or model number.
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For applicable products, consult instructions for use on manuals.medtronic.com.
Home The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Healthcare Professionals Cardiovascular Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure.
With an updated browser, you will have a better Medtronic website experience. 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 <4.0m/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. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. With an updated browser, you will have a better Medtronic website experience.
With an updated browser, you will have a better Medtronic website experience. Lowest delivery profile
Update my browser now. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Access instructions for use and other technical manuals in the Medtronic Manual Library. Unfavorable reaction by the body (allergicreaction) to: Antiplatelet agents blood-thinningmedicines that keep blood clots from forming, Contrast medium a substance used toincrease the visualization of body structuressuch as X-ray dye. November 2016;18(11):67.
Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Premarket Approval (PMA) - Food and Drug Administration T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k
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Healthcare Professionals It is possible that some of the products on the other site are not approved in your region or country. performance of the Evolut platform over time. * Third party brands are trademarks of their respective owners. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure.
Broadest annulus range based on CT derived diameters.
Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic
After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Reach out to LifeLine CardioVascular Tech Support with questions.
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.
These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system.
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Home The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures.
Object Category Heart Valves and Annuloplasty Rings. * Third party brands are trademarks of their respective owners. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Cardiovascular 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile.
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. Object Info: - MRI Safety Less information (see less).
Refer to the Instructions for Use for available sizes. Third attempt must be a complete recapture and retrieval from patient. Manuals can be viewed using a current version of any major internet browser. Products Keep appointments with your doctor.
- (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5,
l@ !W Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa.
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.
Medtronic Announces CE Mark of Evolut PRO+ TAVI System for Treatment 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.
Broadest annulus range*
PDF PRO TAVR SPECIFICATIONS - asiapac.medtronic.com Indications, Safety, and Warnings Product Details Cardiovascular
For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Explore our valve design and theperformance of the Evolut platform over time. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft.
If you continue, you may go to a site run by someone else.
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Less information (see less). including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. With an updated browser, you will have a better Medtronic website experience.
During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. 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. More information (see more)
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.
A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. Less information (see less). Find additional feature information, educational resources, and tools. Patients PDF Summary of Safety and Effectiveness Data I. General Information
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. Update my browser now. Seleccione su regin. Evolut PRO+ - Transcatheter Aortic Heart Valves | Medtronic
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US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products.
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.
AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com.
Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. $G` In addition, patient age should be considered as long-term durability of the valve has not been established. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. What is Evolut pro valve made of? - Studybuff
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). Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US 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.
With an abnormal growth in the heart or arteries, Whose failing valve is too small or too big, Whose arteries are too small for the device, Whose arteries that deliver blood to the heart maybe blockedby the device, Whose arteries that deliver blood to the heart need tobe treated, Whose arteries that deliver blood to the brain need tobe treated, Who have a reaction to some imaging solutions, cannot take medications that reduce the risk of blood clots, or who have a reaction to somemetals, Who have severe problems with bleeding or bloodclotting, Who have specific types of surgical valves implanted in the pulmonaryvalve, Who have specific types of surgical valves implanted in the mitralvalve, Who have thick heart muscles, making it difficult for the heart to pumpblood, Who have thick heart muscles that block the heart from pumpingblood, Who need to have a surgical procedure on theiraorta. Transcatheter Aortic Heart Valves If you continue, you may go to a site run by someone else.
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. Treatments & Therapies Medtronic MRI Resource Library Technical Information for Healthcare Professionals. Prosthesis-patient mismatch: definition, clinical impact, and prevention. All other brands are trademarks of a Medtronic company. Home Heart.
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.