This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. 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 Update my browser now. Find additional feature information, educational resources, and tools. Typically devices associated with implantation (e.g., catheter, introducer) are included. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. Home Prevent kinking of the catheter when removing it from the packaging. Evolut PRO System Sealing + Performance By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Products Flameng, W, et al. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. 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. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . A steel oxygen tank is never permitted inside of the MRI system room. Quickly search hundreds of MRI safety related articles. Heart. The EnVeo PRO delivery system assists in accurate positioning of the valve. 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 EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. If you continue, you will leave this site and go to a site run by someone else. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Epub 2017 Oct 27. Access instructions for use and other technical manuals in the Medtronic Manual Library. Heart. Safety Topics ; Home; help (full/part words) . 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). Visit Amazon.com for more information or to order. GMDN Names and Definitions: Copyright GMDN Agency 2015. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. 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. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. 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. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. Update my browser now. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Third attempt must be a complete recapture and retrieval from patient. Reach out to lifeline cardiovascular tech support with questions. Update my browser now. For information, visit MagneticResonanceSafetyTesting.com NEW for 2022 MRI Textbook Reproduced with Permission from the GMDN Agency. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Lowest delivery profile - (03:26). Heart Valves and Annuloplasty Rings More. 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. Programs for MR personnel include: "Introduction to MRI Safety", "Basic MRI Safety Training", and "Advanced MRI Safety Training For Healthcare Professionals". for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. 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 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. 1.5, 3: Conditional 8 More. Home Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Reproduced with Permission from the GMDN Agency. You just clicked a link to go to another website. Anatomical characteristics should be considered when using the valve in this population. 9850 NW 41st Street, Suite 450, Doral, FL 33178 Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Your Resource for MRI Safety, Bioeffects,& Patient Management. Avoid exposing to extreme fluctuations of temperature. If you continue, you may go to a site run by someone else. Read our disclaimer for details. Click OK to confirm you are a Healthcare Professional. 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. Healthcare Professionals Broadest annulus range* The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. 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. J Am Coll Cardiol. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the valve Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. Aortic valve, prosthesis, percutaneously delivered. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Find safety related information pertaining to thousands of specific implants or devices. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. 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, Evolut PRO+ TAVI System Damage may result from forceful handling of the catheter. Heart. 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. 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. Up to 80% deployment. Home Cardiovascular Find additional feature information, educational resources, and tools. 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. 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