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J Am Coll Cardiol. Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Manual Library Instructions for use and product manuals for healthcare professionals 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. The bioprosthesis size must be appropriate to fit the patients anatomy. 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. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. Training is available through AppliedRadiology.com. 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. Full commercial launch is anticipated in early calendar year 2022. 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. See how the external tissue wrap on the Evolut PRO TAVI performs. An office chair was in the wrong place - at ANY time! Contact Us; About Us; Group; Aortic valve, prosthesis, percutaneously delivered. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. 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 . Find additional feature information, educational resources, and tools. Aortic valve, prosthesis, percutaneously delivered, Storage Environment Temperature: more than 0 Degrees Celsius. As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). Aortic transcatheter heart valve bioprosthesis, stent-like framework. Heart Valves and Annuloplasty Rings More. From a design built on a proven platform1, the EVOLUT PRO+ system provides the performance and outcomes you need to help patients live life to the fullest. 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. Click OK to confirm you are a Healthcare Professional. Click OK to confirm you are a Healthcare Professional. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. 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: Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. For applicable products, consult instructions for use on manuals.medtronic.com. With an updated browser, you will have a better Medtronic website experience. Broadest annulus range* 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. Broadest annulus range based on CT derived diameters. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. 1.5, 3: Conditional 8 More. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient 40mmHg, or a peak aortic-jet velocity 4.0m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient <40mmHg, and a peak aortic-jet velocity <4.0 m/s; with untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve; patients with liver failure (Child-Pugh Class C); with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; patients who are pregnant or breastfeeding. It is possible that some of the products on the other site are not approved in your region or country. With an updated browser, you will have a better Medtronic website experience. Circulation. 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. Aortic transcatheter heart valve bioprosthesis, stent-like framework. GO TO THE LIBRARY (opens new window) Medtronic, www.medtronic.com The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. Limited commercial release is planned for the fall with a full launch anticipated in early 2022. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Visit: IMRSER Videos. 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 . - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. 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. Click OK to confirm you are a Healthcare Professional. Products GMDN Names and Definitions: Copyright GMDN Agency 2015. With a design built on the proven Evolut platform, the Evolut PRO+ system features: Lowest delivery profile Products Home Access instructions for use and other technical manuals in the Medtronic Manual Library. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Broadest annulus range based on CT derived diameters. Transcatheter Aortic Heart Valves Cardiovascular All other brands are trademarks of a Medtronic company. November 1, 1999;34(5):1609-1617. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Medtronic, www.medtronic.com. Healthcare Professionals GMDN Definition. Search by the product name (e.g., Evolut) or model number. for access down to 5.0 mm vessels with the 23-29 mm valves. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. The Confida Brecker guidewire (CBG) is specifically designed for TAVI procedures. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. It is possible that some of the products on the other site are not approved in your region or country. Damage may result from forceful handling of the catheter. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. * Third party brands are trademarks of their respective owners. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . If you continue, you may go to a site run by someone else. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. 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% Find additional feature information, educational resources, and tools. Frank.ShellockREMOVE@MRIsafety.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. Healthcare Professionals Heart. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. 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. Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. 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