Bleiziffer S, Eichinger WB, Hettich I, et al. 9850 NW 41st Street, Suite 450, Doral, FL 33178 Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. In addition, patient age should be considered as long-term durability of the valve has not been established. Update my browser now. Search by the product name (e.g., Evolut) or model number. 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. 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 . Less information (see less). Up to 80% deployment. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Cardiovascular Access instructions for use and other technical manuals in the Medtronic Manual Library. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI Advanced sealing Manual Library Instructions for use and product manuals for healthcare professionals 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. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. For best results, use Adobe Acrobat Reader with the browser. Excessive contrast media may cause renal failure. Medtronic, www.medtronic.com Aortic valve, prosthesis, percutaneously delivered. Manuals can be viewed using a current version of any major internet browser. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. 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. MRIsafety.com is Exclusively Sponsored by BRACCO, MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Home If you continue, you may go to a site run by someone else. Find additional feature information, educational resources, and tools. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Broadest annulus range* 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. With an updated browser, you will have a better Medtronic website experience. 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. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. You just clicked a link to go to another website. Aortic transcatheter heart valve bioprosthesis, stent-like framework. The Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. For applicable products, consult instructions for use on manuals.medtronic.com. 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. Update my browser now. Cardiovascular Reach out to LifeLine CardioVascular Tech Supportwith questions. Heart. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Anatomical characteristics should be considered when using the valve in this population. Healthcare Professionals Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. It is possible that some of the products on the other site are not approved in your region or country. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Read our disclaimer for details. 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. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. If you continue, you may go to a site run by someone else. For applicable products, consult instructions for use on manuals.medtronic.com. Aortic transcatheter heart valve bioprosthesis, stent-like framework. General Clinical long-term durability has not been established for the bioprosthesis. available. 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. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. January 2016;102(2):107-113. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. A steel oxygen tank is never permitted inside of the MRI system room. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". The bioprosthesis size must be appropriate to fit the patients anatomy. Today, the Evolut PRO+ valve design means no tradeoffs. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 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. Broadest annulus range based on CT derived diameters. Broadest annulus range based on CT derived diameters. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. Heart. 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. August 2006;92(8);1022-1029. Up to 80% deployment. 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. The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging 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. 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). With an updated browser, you will have a better Medtronic website experience. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. GMDN Definition. GO TO THE LIBRARY (opens new window) Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. +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. 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. 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. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Avoid prolonged or repeated exposure to the vapors. Find more detailed TAVRinformation, educationalresources, and tools. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. Typically devices associated with implantation (e.g., catheter, introducer) are included. Cardiovascular Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. All other brands are trademarks of a Medtronic company. Home GMDN Names and Definitions: Copyright GMDN Agency 2015. document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Third attempt must be a complete recapture and retrieval from patient. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Less information (see less). Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Evolut PRO+ Reach out to lifeline cardiovascular tech support with questions. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook You just clicked a link to go to another website. Training is available through AppliedRadiology.com. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. Safety Topics ; Home; help (full/part words) . 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. For information, visit MagneticResonanceSafetyTesting.com. 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 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 . During the procedure, monitor contrast media usage. Transcatheter Aortic Heart Valves. Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years. Contact Us; About Us; Group; Manuals and technical guides In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. 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. Fewer instances of prosthesis-patient mismatch (PPM), which has been correlated to improved long-term survival, A large EOA provides improved flow, less resistance, and better long-term durability. Access instructions for use and other technical manuals in the Medtronic Manual Library. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. Third attempt must be a complete recapture and retrieval from patient. 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: 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. 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. It is possible that some of the products on the other sitenot be licensed for sale in Canada. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. 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 GMDN Names and Definitions: Copyright GMDN Agency 2015. Proper sizing of the devices is the responsibility of the physician. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Download MRI pre-screening forms for patients and MR personnel. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM Broadest annulus range based on CT derived diameters for self-expanding valves. Click OK to confirm you are a Healthcare Professional. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. With an updated browser, you will have a better Medtronic website experience. If you continue, you will leave this site and go to a site run by someone else. November 2016;18(11):67. Up to 80% deployment. 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. 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. An office chair was in the wrong place - at ANY time! 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. 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