See how the external tissue wrap on the Evolut PRO TAV performs.
Proper sizing of the devices is the responsibility of the physician.
2020 Medtronic. Healthcare Professionals Flameng, W, et al. The valve can be partially or fully recaptured up to three times prior to the point of no recapture.
EVOLUT PRO+ SYSTEM Transcatheter Aortic Valve Implantation (TAVI) The next generation Evolut TM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster.
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THE List - MRI Safety The Evolut R valve was built on the proven design of our CoreValve platform and features a supra-annular, self-expanding nitinol frame with a low delivery profile. SPECIFICATIONS Evolut PRO+ TAV R BIOPROSTHESIS Evolut PRO+ 23 mm Valve Evolut PRO+ 26 mm Valve Model Number: EVPROPLUS-23US Size: 23 mm Aortic annulus diameter: 17*/18-20 mm Model Number: EVPROPLUS-26US Size: 26 mm Aortic annulus diameter: 20-23 mm LOADING SYSTEM Evolut PRO+ Loading System Model Number: L-EVPROP2329US
The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule.
Medtronic MRI Resource Library: Home
Conduct the procedure under fluoroscopy. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment.
Manuals and technical guides
Broadest annulus range*
November 2016;18(11):67. Manuals can be viewed using a current version of any major internet browser. Go .
Update my browser now. Your doctor can let you know which risks will most likely apply to you. Heart. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure.
Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic Broadest annulus range based on CT derived diameters. Third attempt must be a complete recapture and retrieval from patient. Transcatheter Aortic Heart Valves
Reach out to LifeLine CardioVascular Tech Support with questions.
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The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. 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).
Home For applicable products, consult instructions for use on manuals.medtronic.com. Find more detailed TAVRinformation, educationalresources, and tools.
Please talk to your doctor to decide whether this therapy is right for you. Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With.
Evolut FX system enhancements make TAVR procedures easier to visualize and more predictable.
Complications at the area where the doctor cutthe skin or related to cutting the skin, includingbut not limited to: Hematoma blood collecting under the skin, Pseudoaneurysm blood collecting on theoutside of a vessel wall causing a balloon-likewidening, Irreversible nerve damage permanentdamage to nerves, Compartment syndrome squeezing ofnerves and muscles in a closed space thatcould cause muscle or nerve damage, Stenosis narrowing of a blood vessel(artery), Mitral valve regurgitation blood leakingbackward through the valve between the leftlower chamber of the heart to the left upperchamber of the heart, Hypotension or hypertension low or highblood pressure, Bowel ischemia decreased blood supply tothe intestines. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. 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. The Evolut PRO valve features an external tissue wrap added to the proven platform design. 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.
CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI
MRI safety information | Edwards Lifesciences
Lowest delivery profile
- (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang 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. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Evolut FX
It is possible that some of the products on the other site are not approved in your region or country. How long it lasts varies from patient to patient. Indications, Safety, & Warnings. 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. 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.
Transcatheter Aortic Heart Valves
THE List - MRI Safety
The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market.
Transcatheter Aortic Heart Valves | Medtronic Cardiovascular 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.
2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z.
AccessGUDID - DEVICE: Evolut PRO+ (00763000211127)
Evolut FX TAVR/TAVI Deployment Video
Evolut PRO+ - Transcatheter Aortic Heart Valves | Medtronic The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. performance of the Evolut platform over time. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). If you continue, you may go to a site run by someone else. Home
- (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Evolut FX.
If you continue, you may go to a site run by someone else. Evolut PRO. 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.
3: Conditional 5 More.
You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name.
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. Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. Transcatheter Aortic Heart Valves.
Healthcare Professionals
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What is Evolut pro valve made of? - Studybuff
Update my browser now. Please select your region. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Evaluate bioprosthesis performance as needed during patient follow-up. 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.
Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
2010; 121:2123-2129.
PDF Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk
Home Healthcare Professionals Select country / region and language . The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Cardiovascular The bioprosthesis size must be appropriate to fit the patients anatomy. 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). Radiopaque gold markers provide a reference for deployment depth and commissure location. The EnVeo PRO delivery system assists in accurate positioning of the valve. Pibarot P, Dumesnil JG. Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. Language Remember My Preferences.
Up to 80% deployment.
The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Medtronic MRI Resource Library Technical Information for Healthcare Professionals.
MRI Verify | Medtronic Third attempt must be a complete recapture and retrieval from patient. You may also call800-961-9055 for a copy of a manual.
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.
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. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range.
Broadest annulus range based onCT-derived diameters. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. * Third party brands are trademarks of their respective owners. Selezionare la propria regione. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Keep appointments with your doctor. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS
Allows access down to5.0 mm vessels with2329 mm valves. 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 supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA).