Cardiovascular You may also call 800-961-9055 for a copy of a manual. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR), 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. 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. 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. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Transcatheter Aortic Heart Valves United States of America * Country / Region. MRI-Related Heating In non-clinical testing, the implant/device produced the following temperature rises during MRI performed for 15-minutes (i.e. Update my browser now. 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. 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. Healthcare Professionals Object Category Heart Valves and Annuloplasty Rings. What is a Medtronic valve? The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. It is possible that some of the products on the other site are not approved in your region or country. 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. With an updated browser, you will have a better Medtronic website experience. Pibarot P, Dumesnil JG. The EnVeo PRO delivery system assists in accurate positioning of the valve. 4588 0 obj <>stream TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Home The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. 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. Medtronic MRI Resource Library Technical Information for Healthcare Professionals. 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). If you continue, you may go to a site run by someone else. With an updated browser, you will have a better Medtronic website experience. PRODUCT DETAILS EXCEPTIONAL DESIGN - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. 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. Up to 80% deployment. Cardiovascular 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. Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. 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 Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Evolut PRO. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Reach out to LifeLine CardioVascular Tech Support with questions. 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). Broadest annulus range based onCT-derived diameters. Explore our valve design and theperformance of the Evolut platform over time. November 2016;18(11):67. T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. See the Evolut R System. With an updated browser, you will have a better Medtronic website experience. Object Status Conditional 8. Conduct the procedure under fluoroscopy. With an updated browser, you will have a better Medtronic website experience. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. 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. For applicable products, consult instructions for use on manuals.medtronic.com. 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 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 Click OK to confirm you are a Healthcare Professional. Manuals can be viewed using a current version of any major internet browser. 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. Update my browser now. Evaluate bioprosthesis performance as needed during patient follow-up. Evolut FX system enhancements make TAVR procedures easier to visualize and more predictable. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Home Recapture and reposition * Third party brands are trademarks of their respective owners. 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 Evolut PRO+. Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. Reach out to LifeLine CardioVascular Tech Supportwith questions. The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. 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. Flameng, W, et al. Healthcare Professionals hb```lu eah(x B More information (see more) Prior to the procedure, measure the patients creatinine level. With an updated browser, you will have a better Medtronic website experience. Circulation. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. Meet the Evolut R System. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Please select your region. 2010; 121:2123-2129. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 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 Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. All other brands are trademarks of a Medtronic company. 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 supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 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 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. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX Keep appointments with your doctor. 3: Conditional 5 More. English. 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 bioprosthesis size must be appropriate to fit the patients anatomy. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Access instructions for use and other technical manuals in the Medtronic Manual Library. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Heart Valves and Annuloplasty Rings More. Indications, Safety, and Warnings Product Details The valve can be partially or fully recaptured up to three times prior to the point of no recapture. 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. 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. Update my browser now. Flameng, W, et al. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Curr Treat Options Cardiovasc Med. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Your doctor can let you know which risks will most likely apply to you. including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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. All other brands are trademarks of a Medtronic company. 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. Safety Info ID# Safety Topic / Subject Article Text 179: . Third attempt must be a complete recapture and retrieval from patient. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. The external wrap increases surface contact with native anatomy, providing advanced sealing. Search by the product name (e.g., Evolut) or model number. Evolut FX TAVR/TAVI Deployment Video Transcatheter Aortic Heart Valves Search by the product name (e.g., Evolut) or model number. Manuals and technical guides Broadest annulus range based on CT derived diameters. Update my browser now. 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. Transcatheter Aortic Heart Valves If you continue, you may go to a site run by someone else. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. J Am Coll Cardiol. At some point, the Medtronic TAVR valve may need tobe replaced. Please talk to your doctor to decide whether this therapy is right for you. Heart. Update my browser now. Selecione a sua regio. Broadest annulus range* Products Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Manuals can be viewed using a current version of any major internet browser. 2023 Medtronic . Click OK to confirm you are a Healthcare Professional. 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. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Bench testing may not be indicative of clinical performance. endstream endobj startxref EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Proper sizing of the devices is the responsibility of the physician. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. January 2016;102(2):107-113. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. 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. Transcatheter Aortic Heart Valves 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. In addition, patient age should be considered as long-term durability of the valve has not been established. performance of the Evolut platform over time. Products Patients who do not are more likely to have a stroke. Cardiovascular 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 . Products Language Remember My Preferences. 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. Healthcare Professionals Medtronic, www.medtronic.com Home Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. 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. 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). PDF View Shellock R & D Services, Inc. email: . 4544 0 obj <> endobj The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Medtronic, www.medtronic.com. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. 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 Update my browser now. Home Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. PRODUCT DETAILS EXCEPTIONAL DESIGN You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Broadest annulus range based on CT derived diameters. Refer to the Instructions for Use for available sizes. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. Lowest delivery profile Reach out to LifeLine CardioVascular Tech Support with questions. `)\;>! Home Cardiovascular Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. %PDF-1.5 % Evolut FX Click OK to confirm you are a Healthcare Professional. Home Up to 80% deployment. $G` Find more detailed TAVRinformation, educationalresources, and tools. 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. 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.

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