2010; 121:2123-2129. Products For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. November 2016;18(11):67. hbbd``b`kS`o%@y)x Reach out to LifeLine CardioVascular Tech Support with questions. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. J Am Coll Cardiol. TAVR currentlyis approvedfor patients withheart diseasedue to symptomatic severe aortic stenosis of the native valve, and patients with a failingsurgical aortic valve who are at high risk or extreme riskdue to symptomatic, severe aortic stenosis for complications during surgery. With an updated browser, you will have a better Medtronic website experience. November 1, 1999;34(5):1609-1617. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS Reach out to LifeLine CardioVascular Tech Support with questions. Home See the Evolut R System. 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. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Click OK to confirm you are a Healthcare Professional. 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 < 17 mm. Broadest annulus range* Title Transcatheter Aortic Valve Replacement (TAVR) with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement (SAVR) Product Name Medtronic TAVR System: xEvolut PRO Transcatheter Aortic Valve (TAV) 23, 26, and 29 mm xEvolut R 23, 26, 29, and 34 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. 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. 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. It is possible that some of the products on the other site are not approved in your region or country. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 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. Search by the product name (e.g., Evolut) or model number. Broadest annulus range based on CT derived diameters. Manuals can be viewed using a current version of any major internet browser. General Clinical long-term durability has not been established for the bioprosthesis. See how the external tissue wrap on the Evolut PRO TAV performs. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Medtronic MRI Resource Library Technical Information for Healthcare Professionals. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Please talk to your doctor to decide whether this therapy is right for you. It is possible that some of the products on the other site are not approved in your region or country. 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% Cardiovascular - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Access instructions for use and other technical manuals in the Medtronic Manual Library. More information (see more) Update my browser now. Circulation. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. With an updated browser, you will have a better Medtronic website experience. Select country / region and language . More information (see more) Home Explore our valve design and theperformance of the Evolut platform over time. For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. Home PRODUCT DETAILS EXCEPTIONAL DESIGN Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Transcatheter Aortic Heart Valves With an updated browser, you will have a better Medtronic website experience. August 2006;92(8);1022-1029. English. Curr Treat Options Cardiovasc Med. Pibarot P, Dumesnil JG. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Search by the product name (e.g., Evolut) or model number. With an updated browser, you will have a better Medtronic website experience. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Update my browser now. Avoid prolonged or repeated exposure to the vapors. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Healthcare Professionals Not doing so could result in injury or death. PRODUCT DETAILS EXCEPTIONAL DESIGN More information (see more) All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Heart. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Damage may result from forceful handling of the catheter. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name 4544 0 obj <> endobj What is a Medtronic valve? You may also call 800-961-9055 for a copy of a manual. 4564 0 obj <>/Filter/FlateDecode/ID[<2C0E24D68A9BFB4295F1AF0A6EE224DC>]/Index[4544 45]/Info 4543 0 R/Length 94/Prev 676184/Root 4545 0 R/Size 4589/Type/XRef/W[1 2 1]>>stream Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. We are here for you. Products 3: Conditional 5 More. During the procedure, monitor contrast media usage. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Antibiotics maybe recommendedfor patients who are at risk of infections. The external wrap increases surface contact with native anatomy, providing advanced sealing. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Evaluate bioprosthesis performance as needed during patient follow-up. Language Remember My Preferences. 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). Search by the product name (e.g., Evolut) or model number. Up to 80% deployment. Evolut PRO. The EnVeo PRO delivery system assists in accurate positioning of the valve. Update my browser now. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. Your use of the other site is subject to the terms of use and privacy statement on that site. See how the external tissue wrap on the Evolut PRO TAVI performs. Seleccione su regin. 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. Less information (see less). Transcatheter Aortic Heart Valves Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. If you continue, you may go to a site run by someone else. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Selezionare la propria regione. Prior to the procedure, measure the patients creatinine level. With an updated browser, you will have a better Medtronic website experience. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX 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. 2020 Medtronic. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. 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. 2010; 121:2123-2129. See how the external tissue wrap on the Evolut PRO TAVI performs. 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. 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. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Refer to the Instructions for Use for available sizes. Medtronic, www.medtronic.com. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. 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. 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. August 2006;92(8);1022-1029. 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). Broadest annulus range based on CT derived diameters. Safety Topic / Subject Heart Valves and Annuloplasty Rings. 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. Radiopaque gold markers provide a reference for deployment depth and commissure location. How long it lasts varies from patient to patient. 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. With an updated browser, you will have a better Medtronic website experience. DUBLIN, Aug. 24, 2021 / PRNewswire (opens new window) / -- Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Products Or, you may contact technical support online. November 2016;18(11):67. 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. Evolut FX TAVR/TAVI Deployment Video If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. The Evolut PRO valve features an external tissue wrap added to the proven platform design. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. For best results, use Adobe Acrobat Reader with the browser. Healthcare Professionals Skip to main content English It is possible that some of the products on the other site are not approved in your region or country. 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. Excessive contrast media may cause renal failure. 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. This could make you feel sick or cause death. Cardiovascular $/R$J101 Meet the Evolut R System. Cardiovascular Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. * Third party brands are trademarks of their respective owners. With an updated browser, you will have a better Medtronic website experience. 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. Third attempt must be a complete recapture and retrieval from patient. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Patients Transcatheter Aortic Heart Valves Click OK to confirm you are a Healthcare Professional. If you continue, you may go to a site run by someone else. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (e.g., STS predicted risk of operative mortality score 8% or at a 15% risk of mortality at 30 days). Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Please select your region. Cardiovascular Update my browser now. Find additional feature information, educational resources, and tools. Third attempt must be a complete recapture and retrieval from patient. Update my browser now. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Conduct the procedure under fluoroscopy. Strength 1.5, 3. `)\;>! Flameng, W, et al. 2023 Medtronic . These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. The bioprosthesis size must be appropriate to fit the patients anatomy. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. X'AD`4.$ 2 MRI-Related Heating In non-clinical testing, the implant/device produced the following temperature rises during MRI performed for 15-minutes (i.e. Indications, Safety, and Warnings Product Details Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 2020 Medtronic. Home Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. 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. 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. All other brands are trademarks of a Medtronic company. Home 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. %%EOF 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 delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. 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 Find more detailed TAVRinformation, educationalresources, and tools. 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. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W Flameng, W, et al. Lowest delivery profile You just clicked a link to go to another website. 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. Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. More information (see more) %PDF-1.5 % The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Bitte whlen Sie Ihre Region. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Third attempt must be a complete recapture and retrieval from patient. Medtronic, www.medtronic.com Products 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. Up to 80% deployment. 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. United States of America * Country / Region. Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. 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 Valve Replacement (TAVR) 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. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Follow all care instructions to ensure the best possible results. For applicable products, consult instructions for use on manuals.medtronic.com. 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