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. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. During rinsing, do not touch the leaflets or squeeze the bioprosthesis. Click “OK” to confirm you are a Healthcare Professional. This site uses cookies to store information on your computer. INDICATIONS. During the procedure, monitor contrast media usage. For subclavian access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using Models ENVPRO-14-US/ENVEOR-L-US/D-EVPROP2329US or ≥ 6 mm when using Models ENVPRO-16-US and ENVEOR-N-US or ≥ 6.5 mm when using Model D-EVPROP34US. Do not use the trigger for deploying or recapturing because it could cause inaccurate placement of the bioprosthesis. The CoreValve Evolut R and PRO systems are contraindicated for patients presenting with any of the following conditions: Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (titanium or nickel), or sensitivity to contrast media, which cannot be adequately pre-medicated; ongoing sepsis, including active endocarditis; and pre-existing mechanical heart valve in the aortic position. TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), https://europe.medtronic.com/xd-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22017, Transcatheter Aortic Valve Implantation (TAVI). Implanting a CoreValve Evolut R, Evolut PRO, or Evolut PRO+ 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. With an updated browser, you will have a better Medtronic website experience. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Refer to the specific balloon catheter manufacturer’s labeling for proper instruction on the use of balloon catheter devices. General Implantation of the CoreValve Evolut R, PRO, and PRO+ systems should be performed only by physicians who have received Medtronic CoreValve Evolut R, PRO, or PRO+ training. Get the latest research from NIH: https://www.nih.gov/coronavirus. In the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilatation of the bioprosthesis may improve valve function and sealing. Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. The CoreValve and Evolut transcatheter aortic valve replacement (TAVR) devices have been evaluated in more than a dozen clinical trials. Some are essential to make our site work; others help us improve the user experience. 2020 May;28(5):253-265. doi: 10.1007/s12471-020-01414-0. Conduct the procedure under fluoroscopy. Do not attempt to reload a damaged bioprosthesis. In addition, patient age should be considered as long-term durability of the valve has not been established. TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act, 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, 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.

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