Access instructions for use and other technical manuals in the Medtronic Manual Library. Visit: IMRSER Videos. Transcatheter Aortic Heart Valves You just clicked a link to go to another website. GMDN Preferred Term Name GMDN Definition; Aortic transcatheter heart valve bioprosthesis, stent-like framework An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral . Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. About MedtronicMedtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies alleviating pain, restoring health and extending life for millions of people around the world. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Training is available through AppliedRadiology.com. During the procedure, monitor contrast media usage. Aortic valve, prosthesis, percutaneously delivered. Search by the product name (e.g., Evolut) or model number. These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years. Home Find safety related information pertaining to thousands of specific implants or devices. Potential risks associated with the implantation of the CoreValve Evolut R, Evolut PRO+, or Evolut FX transcatheter aortic valve may include, but are not limited to, the following: Please reference the CoreValve Evolut R, Evolut PRO+, and Evolut FX Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events. Skip to main content English Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Heart Valves and Annuloplasty Rings More. For best results, use Adobe Acrobat Reader with the browser. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Typically devices associated with implantation (e.g., catheter, introducer) are included. Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," said Jeffrey Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. August 2006;92(8);1022-1029. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Up to 80% deployment. If you continue, you will leave this site and go to a site run by someone else. It is possible that some of the products on the other site are not approved in your region or country. The EnVeo PRO delivery system assists in accurate positioning of the valve. Damage may result from forceful handling of the catheter. 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. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . Transcatheter Aortic Heart Valves. Prevent kinking of the catheter when removing it from the packaging. An office chair was in the wrong place - at ANY time! Cardiovascular For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook 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 Advanced sealing 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Anatomical characteristics should be considered when using the valve in this population. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. 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. 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. More information (see more) 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. For best results, use Adobe Acrobat Reader with the browser. 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. +1 (305) 500-9328, Evolut FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. Find additional feature information, educational resources, and tools. GMDN Preferred Term Name. * Third party brands are trademarks of their respective owners. For information, visit MagneticResonanceSafetyTesting.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% Home Curr Treat Options Cardiovasc Med. for access down to 5.0 mm vessels with the 23-29 mm valves. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. Medtronic, www.medtronic.com. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . Home Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Your use of the other site is subject to the terms of use and privacy statement on that site. GMDN Names and Definitions: Copyright GMDN Agency 2015. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. Your use of the other site is subject to the terms of use and privacy statement on that site. It provides the lowest delivery profile and added surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. Data on file (>20 clinical trials with over 20000 patients enrolled). Transcatheter Aortic Valve Implantation (TAVI), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Assists in accurate positioning of the valve, Features a 1:1 response for immediate feedback between the deployment knob and the movement of the capsule, Provides you the option to recapture and reposition. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience 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. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. 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. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. 2020 Medtronic. For applicable products, consult instructions for use on manuals.medtronic.com. Heart. November 2016;18(11):67. Actual results may differ materially from anticipated results. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Healthcare Professionals Update my browser now. Download MRI pre-screening forms for patients and MR personnel. Avoid freezing. Update my browser now. If you continue, you may go to a site run by someone else. Central/Eastern Europe, Middle East & Africa. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. With an updated browser, you will have a better Medtronic website experience. for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. 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 (e.g., STS predicted risk of operative mortality score 8% or at a 15% risk of mortality at 30 days). 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. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Search by the product name (e.g., Evolut) or model number. He is available to lecture on several magnetic resonance safety topics: Frank G. Shellock, Ph.D. is a physiologist with more than 30 years of experience conducting laboratory and clinical investigations in the field of magnetic resonance imaging. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Broadest annulus range based on CT derived diameters. 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