Manuals and technical guides Avoid exposing to extreme fluctuations of temperature. 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 Healthcare Professionals This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Heart. (This site is Exclusively Sponsored by BRACCO). January 2016;102(2):107-113. Search by the product name (e.g., Evolut) or model number. It is possible that some of the products on the other site are not approved in your region or country. Typically devices associated with implantation (e.g., catheter, introducer) are included. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Full commercial launch is anticipated in early calendar year 2022. General Clinical long-term durability has not been established for the bioprosthesis. It is possible that some of the products on the other sitenot be licensed for sale in Canada. Heart. You just clicked a link to go to another website. Medtronic Canada does not review or control the content on the other website, and is not responsible for any business dealings or transactions you have there. We currently do not have this item in stock, but we can email you as soon as it is available. Avoid exposing to extreme fluctuations of temperature. 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. 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. Methods. 9850 NW 41st Street, Suite 450, Doral, FL 33178 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. 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. Safety Info ID# Safety Topic / Subject Article Text 179: Heart Valves and Annuloplasty Rings: Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera. Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. With an updated browser, you will have a better Medtronic website experience. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. Reproduced with Permission from the GMDN Agency. The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. 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. 4 Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery. available. 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 For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Healthcare Professionals August 2006;92(8);1022-1029. 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. The fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant. Broadest annulus range based on CT derived diameters for self-expanding valves. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. ClinicalTrials.gov Identifier: NCT02701283 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. 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. Epub 2017 Oct 27. Find additional feature information, educational resources, and tools. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . See the Evolut R System. You just clicked a link to go to another website. 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. Access instructions for use and other technical manuals in the Medtronic Manual Library. Prior to the procedure, measure the patients creatinine level. Patients must present with transarterial access vessel diameters of 5mm when using models ENVEOR-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 5.5mm when using model ENVEOR-N-US or 6mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site 60mm from the basal plane for both systems. Avoid freezing. It is possible that some of the products on the other site are not approved in your region or country. Home Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. See how the external tissue wrap on the Evolut PRO TAVI performs. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Device Dimensions Operating and Storage Conditions Device Identifiers FDA Pre-market Approvals/Notifications & deNovo Premarket Approval: P130021 FDA Product Code NPT Aortic valve, prosthesis, percutaneously delivered Sterilization Device Entry Metadata On-Brand Devices [Evolut PRO+] Trademark Results [Evolut] 2022 FDA.report A steel oxygen tank is never permitted inside of the MRI system room. 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