evolut pro plus mri safety
Your use of the other site is subject to the terms of use and privacy statement on that site. Read our disclaimer for details. 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 FX system incorporates the same supra-annular valve design that has shown hemodynamic performance superior to surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Epub 2017 Oct 27. Heart Valves and Annuloplasty Rings More. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. With an updated browser, you will have a better Medtronic website experience. Bleiziffer S, Eichinger WB, Hettich I, et al. Excessive contrast media may cause renal failure. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Reproduced with Permission from the GMDN Agency. Healthcare Professionals For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Home Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Avoid exposing to extreme fluctuations of temperature. 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. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. More information (see more) Healthcare Professionals Home Broadest annulus range based on CT derived diameters. 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. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Evolut PRO. It is possible that some of the products on the other site are not approved in your region or country. 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. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Broadest annulus range based on CT derived diameters for self-expanding valves. Heart. Home Up to 80% deployment. Your use of the other site is subject to the terms of use and privacy statement on that site. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Broadest annulus range* 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. 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 With an updated browser, you will have a better Medtronic website experience. 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. Aortic transcatheter heart valve bioprosthesis, stent-like framework. 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 DUBLIN, Aug. 24, 2021 /PRNewswire/ --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. Curr Treat Options Cardiovasc Med. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. GMDN Names and Definitions: Copyright GMDN Agency 2015. Full commercial launch is anticipated in early calendar year 2022. +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. If you continue, you will leave this site and go to a site run by someone else. For best results, use Adobe Acrobat Reader with the browser. 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 The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. With an updated browser, you will have a better Medtronic website experience. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. You may also call800-961-9055 for a copy of a manual. 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 . Aortic transcatheter heart valve bioprosthesis, stent-like framework. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. Typically devices associated with implantation (e.g., catheter, introducer) are included. 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. +353 (0)1 4047 113 info@evolut.ie. Avoid prolonged or repeated exposure to the vapors. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. 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. Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. Manuals can be viewed using a current version of any major internet browser. Designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis. English and Spanish forms are Heart. During the procedure, monitor contrast media usage. Healthcare Professionals 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 General Clinical long-term durability has not been established for the bioprosthesis. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience GMDN Preferred Term Name. The bioprosthesis size must be appropriate to fit the patients anatomy. Up to 80% deployment. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. If you continue, you may go to a site run by someone else. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook - (03:26). Cardiovascular Quickly search hundreds of MRI safety related articles. "The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimize paravalvular leak. In addition, patient age should be considered as long-term durability of the valve has not been established. 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. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Manual Library Instructions for use and product manuals for healthcare professionals Avoid exposing to extreme fluctuations of temperature. 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. Evaluate bioprosthesis performance as needed during patient follow-up. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Central/Eastern Europe, Middle East & Africa. Additional Details Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US Size: 29mm Aortic Annulus Diameter: 23-26mm For Use With Loading System: L-EVPROP2329US Delivery Catheter System: D-EVPROP2329US 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. November 1, 1999;34(5):1609-1617. Avoid freezing. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 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. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC <1,000cells/mm3), thrombocytopenia (platelet count <50,000cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17mm or >30mm; transarterial access unable to accommodate an 18Fr introducer sheath or the 14Fr equivalent EnVeo InLine Sheath when using models ENVEOR-US/D-EVPROP2329US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 20Fr introducer sheath or the 16Fr equivalent EnVeo InLine Sheath when using model ENVEOR-N-US or transarterial access unable to accommodate a 22Fr introducer sheath or the 18Fr equivalent Evolut PRO+ InLine Sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient. For information, visit MagneticResonanceSafetyTesting.com. 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. 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. Flameng, W, et al. 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. Cardiovascular If 2 of these factors are present, consider an alternative access route to prevent vascular complications. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Aortic valve, prosthesis, percutaneously delivered. 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. You just clicked a link to go to another website. Third attempt must be a complete recapture and retrieval from patient. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. More information (see more) Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Frank.ShellockREMOVE@MRIsafety.com. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. GO TO THE LIBRARY (opens new window) ClinicalTrials.gov Identifier: NCT02701283 CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Up to 80% deployment. Damage may result from forceful handling of the catheter. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Search by the product name (e.g., Evolut) or model number. More information (see more) Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Prior to the procedure, measure the patients creatinine level. Prevent kinking of the catheter when removing it from the packaging. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. 2020 Medtronic. Typically devices associated with implantation (e.g., catheter, introducer) are included. All other brands are trademarks of a Medtronic company. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Home Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland Click OK to confirm you are a Healthcare Professional. 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. 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.