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. 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. 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 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. From CoreValve to Evolut PRO: Reviewing the Journey of Self - PubMed 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. Evolut FX. Refer to the Instructions for Use for available sizes. MRI Resources | Medtronic Cardiovascular Find more detailed TAVRinformation, educationalresources, and tools. Patients The external wrap increases surface contact with native anatomy, providing advanced sealing. PDF Summary of Safety and Effectiveness Data I. General Information 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 Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Products Find additional feature information, educational resources, and tools. With an updated browser, you will have a better Medtronic website experience. 4544 0 obj <> endobj January 2016;102(2):107-113. It is possible that some of the products on the other site are not approved in your region or country. Transcatheter Aortic Heart Valves 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. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Cardiovascular Healthcare Professionals endstream endobj startxref Cardiovascular t X Medtronic MRI Resource Library: Region More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Avoid prolonged or repeated exposure to the vapors. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Broadest annulus range* Cardiovascular MRI Verify | Medtronic Prosthesis-patient mismatch: definition, clinical impact, and prevention. Home With an updated browser, you will have a better Medtronic website experience. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Medtronic Launches Head-to-Head TAVR Study Comparing the Corevalve Broadest annulus range based on CT-derived diameters. With an updated browser, you will have a better Medtronic website experience. 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. The EnVeo PRO delivery system assists in accurate positioning of the valve. Evolut FX 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. Home You may also call 800-961-9055 for a copy of a manual. 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 Click OK to confirm you are a Healthcare Professional. Home Products Access instructions for use and other technical manuals in the Medtronic Manual Library. We are here for you. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Evolut PRO China Clinical Study - Full Text View - ClinicalTrials.gov Pibarot P, Dumesnil JG. For best results, use Adobe Acrobat Reader with the browser. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. For applicable products, consult instructions for use on manuals.medtronic.com. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Healthcare Professionals Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Indications, Safety, and Warnings Product Details 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. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. endstream endobj 4545 0 obj <. 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. 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. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Your doctor can let you know which risks will most likely apply to you. 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. Patients who do not are more likely to have a stroke. Or, you may contact technical support online. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Reach out to LifeLine CardioVascular Tech Supportwith questions. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . Evolut FX - Transcatheter Aortic Heart Valves | Medtronic November 1, 1999;34(5):1609-1617. Transcatheter Aortic Heart Valves 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. 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. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. 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.
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