Recapture and reposition Products You just clicked a link to go to another website. Radiopaque gold markers provide a reference for deployment depth and commissure location. Selezionare la propria regione. The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic CoreValve Evolut Pro and Pro . More information (see more) More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. See how the external tissue wrap on the Evolut PRO TAV performs. With an updated browser, you will have a better Medtronic website experience. See how the external tissue wrap on the Evolut PRO TAVI performs. 3: Conditional 5 More. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. 2020 Medtronic. For applicable products, consult instructions for use on manuals.medtronic.com. MRI Resources, For clinicians whose patients have a Medtronic system. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. We are here for you. Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. Reach out to LifeLine CardioVascular Tech Supportwith questions. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. Evolut PRO System Sealing + Performance The Evolut PRO valve features an external tissue wrap added to the proven platform design. Curr Treat Options Cardiovasc Med. Update my browser now. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Patients Bitte whlen Sie Ihre Region. Home The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Products T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s Raise your expectations for what is possiblewith the Evolut FX system. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Patients who do not are more likely to have a stroke. 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. Home PRODUCT DETAILS EXCEPTIONAL DESIGN 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. Reach out to LifeLine CardioVascular Tech Support with questions. Less information (see less). Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX 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* Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Transcatheter Aortic Heart Valves. Your use of the other site is subject to the terms of use and privacy statement on that site. The bioprosthesis size must be appropriate to fit the patients anatomy. August 2006;92(8);1022-1029. 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 Up to 80% deployment. 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. If you continue, you may go to a site run by someone else. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . 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). With an updated browser, you will have a better Medtronic website experience. Selecione a sua regio. The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. You just clicked a link to go to another website. 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. 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. 2023 Medtronic . It is possible that some of the products on the other site are not approved in your region or country. All other brands are trademarks of a Medtronic company. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Your use of the other site is subject to the terms of use and privacy statement on that site. August 2006;92(8);1022-1029. Healthcare Professionals Manuals can be viewed using a current version of any major internet browser. 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. Home Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Home 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. Find more detailed TAVRinformation, educationalresources, and tools. 2010; 121:2123-2129. 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. Object Status Conditional 8. With an updated browser, you will have a better Medtronic website experience. 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. For applicable products, consult instructions for use on manuals.medtronic.com. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. United States of America * Country / Region. Up to 80% deployment. It is possible that some of the products on the other site are not approved in your region or country. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Object Category Heart Valves and Annuloplasty Rings. Update my browser now. Safety Info ID# Safety Topic / Subject Article Text 179: . 4588 0 obj <>stream Broadest annulus range based onCT-derived diameters. Treatments & Therapies Meet the Evolut R System. 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. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. You may also call 800-961-9055for a copy of a manual. Access instructions for use and other technical manuals in the Medtronic Manual Library. $G` 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. Transcatheter Aortic Heart Valves 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. 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 EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Manuals can be viewed using a current version of any major internet browser. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Recapture and reposition After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Cardiovascular 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. 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. 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. 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 The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. This could make you feel sick or cause death. 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. Strength 1.5, 3. Access instructions for use and other technical manuals in the Medtronic Manual Library. Third attempt must be a complete recapture and retrieval from patient. 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. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Excessive contrast media may cause renal failure. Find more detailed TAVRinformation, educationalresources, and tools. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. 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. See the Evolut R System. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. 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. Avoid prolonged or repeated exposure to the vapors. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. 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. 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. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Home Please select your region. Search by the product name (e.g., Evolut) or model number. The EnVeo PRO delivery system assists in accurate positioning of the valve. Broadest annulus range* 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Conduct the procedure under fluoroscopy. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. Products Medtronic, www.medtronic.com Veuillez slectionner votre rgion. 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. Up to 80% deployment. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name Less information (see less). Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. t X The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe. Indications, Safety, and Warnings Product Details Update my browser now. January 2016;102(2):107-113. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Epub 2017 Oct 27. Keep appointments with your doctor. Transcatheter Aortic Heart Valves With an updated browser, you will have a better Medtronic website experience. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). Radiopaque gold markers provide a reference for deployment depth and commissure location. For best results, use Adobe Acrobat Reader with the browser. 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. Home Cardiovascular Not doing so could result in injury or death. The external wrap increases surface contact with native anatomy, providing advanced sealing. More information (see more) - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. `)\;>! Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Safety Topic / Subject Heart Valves and Annuloplasty Rings. Evolut FX TAVR/TAVI Deployment Video Flameng, W, et al. Evolut FX Products The external wrap increases surface contact with native anatomy, providing advanced sealing.