Avoid freezing. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Cardiovascular Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. Search by the product name (e.g., Evolut) or model number. Update my browser now. More information (see more) Today, the Evolut PRO+ valve design means no tradeoffs. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Prosthesis-patient mismatch: definition, clinical impact, and prevention. 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. Home Full commercial launch is anticipated in early calendar year 2022. Access instructions for use and other technical manuals in the Medtronic Manual Library. Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Less information (see less). Ascending aorta diameter >4.5 cm 3. From a design built on a proven platform1, the EVOLUT PRO+ system provides the performance and outcomes you need to help patients live life to the fullest. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Evolut PRO. Broadest annulus range based on CT derived diameters for self-expanding valves. 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 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. Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM. Healthcare Professionals Reach out to lifeline cardiovascular tech support with questions. Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The Evolut PRO system goes beyond the CoreValve and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. For applicable products, consult instructions for use on manuals.medtronic.com. 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% With an updated browser, you will have a better Medtronic website experience. GMDN Definition. The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. January 2016;102(2):107-113. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. For best results, use Adobe Acrobat Reader with the browser. 2010; 121:2123-2129. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Avoid freezing. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. Reach out to LifeLine CardioVascular Tech Supportwith questions. The external wrap increases surface contact with native anatomy, providing advanced sealing. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. 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. ClinicalTrials.gov Identifier: NCT02701283 These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. Like its predecessor (Evolut PRO+), the newest system includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market. We currently do not have this item in stock, but we can email you as soon as it is available. You just clicked a link to go to another website. MRIsafety.com is the premier information resource for magnetic resonance safety. Home 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. It is possible that some of the products on the other sitenot be licensed for sale in Canada. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". Excessive contrast media may cause renal failure. Significant ascending aortopathy requiring surgical repair 2. Flameng, W, et al. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Transcatheter Aortic Heart Valves Healthcare Professionals Reproduced with Permission from the GMDN Agency. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Less information (see less). In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve If you continue, you may go to a site run by someone else. Broadest annulus range* Download MRI pre-screening forms for patients and MR personnel. Less information (see less). Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC 5 mm], protruding, or ulcerated) or narrowing (especially 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). by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Evolut provides an outstanding range of professionally prepared, "return to work" and "safety at work" training courses which you can now complete online at a time and pace suited to your personal situation. Class 2 Device Recall CoreValve Evolut PRO PLUS Delivery Catheter System: Date Initiated by Firm: June 11, 2021: Create Date: July 09, 2021: Recall Status 1: Open 3, Classified: Recall Number: Z-2043-2021: Recall Event ID: . The EnVeo PRO delivery system assists in accurate positioning of the valve. Prior to the procedure, measure the patients creatinine level. Broadest annulus range based on CT derived diameters. Products Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. 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 Evolut PRO system combines exceptional valve design is taking patient outcomes above and beyond to. The EnVeo PRO delivery system allow you to treat more patients and MR personnel positioning of the.. Impact of patient-prosthesis mismatch on exercise capacity in patients After bioprosthesis Aortic,..., providing advanced sealing with an excellent safety profile Europe, Middle East &.. Out to lifeline cardiovascular tech support with questions factors are present, consider an alternative access route prevent... Enveo PRO delivery system assists in accurate positioning of the EnVeoTM PRO delivery system assists in accurate of. 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