performance of the Evolut platform over time. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. Medtronic MRI Resource Library: Home This library contains technical information on whether an MRI scan can be performed and how to perform a scan on patients with Medtronic implantable devices. The Evolut R valve was built on the proven design of our CoreValve platform and features a supra-annular, self-expanding nitinol frame with a low delivery profile. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Third attempt must be a complete recapture and retrieval from patient. Manuals and technical guides Medtronic Launches Head-to-Head TAVR Study Comparing the Corevalve MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Heart Valves and Annuloplasty Rings More. Recapture and reposition All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. PDF View Shellock R & D Services, Inc. email: . Indications, Safety, and Warnings - Evolut FX | Medtronic Heart. Transcatheter Aortic Heart Valves. Find additional feature information, educational resources, and tools. With an updated browser, you will have a better Medtronic website experience. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Pibarot P, Dumesnil JG. per pulse sequence) in 1.5-Tesla and 3-Tesla MR systems, using an MR system reported, whole body averaged SAR of 2-W/kg or less, as follows: Highest temperature changes EVPROPLUS-29US: Medtronic Evolut Pro+ Transcatheter Aortic Valve 29mm MRI Verify | Medtronic More information (see more) The Evolut PRO+ system offers the lowest delivery profile for 2329 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealingwith an external tissue wrap on all valve sizes. More information (see more) 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. All other brands are trademarks of a Medtronic company. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Safety Topic / Subject Heart Valves and Annuloplasty Rings. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Bench testing may not be indicative of clinical performance. Search by the product name (e.g., Evolut) or model number. 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. All other brands are trademarks of a Medtronic company. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Heart. Healthcare Professionals US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. 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. Bitte whlen Sie Ihre Region. Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve Evolut PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR). November 2016;18(11):67. 2020 Medtronic. 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. Update my browser now. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment Your use of the other site is subject to the terms of use and privacy statement on that site. 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% The valve can be partially or fully recaptured up to three times prior to the point of no recapture. For applicable products, consult instructions for use on manuals.medtronic.com. Home With an updated browser, you will have a better Medtronic website experience. Keep appointments with your doctor. . Less information (see less). Evolut FX - Transcatheter Aortic Heart Valves | Medtronic Indications, Safety, & Warnings. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Re-engineered delivery system expands flexibility for360 range of motion and increases conformability to the anatomy for a 50% reduction in tracking forces*1 in challenging anatomies. Avoid prolonged or repeated exposure to the vapors. More information (see more) The bioprosthesis size must be appropriate to fit the patients anatomy. Curr Treat Options Cardiovasc Med. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Your use of the other site is subject to the terms of use and privacy statement on that site. hb```lu eah(x B More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. For applicable products, consult instructions for use on manuals.medtronic.com. Object Category Heart Valves and Annuloplasty Rings. See the Evolut R System. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Search by the product name (e.g., Evolut) or model number. Skip to main content English Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. For applicable products, consult instructions for use on manuals.medtronic.com. 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. %%EOF Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Transcatheter Aortic Heart Valves Update my browser now. January 2016;102(2):107-113. Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. Click OK to confirm you are a Healthcare Professional. Click OK to confirm you are a Healthcare Professional. Cardiovascular CoreValve and Evolut TAVR Systems | Medtronic TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis, CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI, CORFLO UltraNon-weightedFeeding TubeStylet RemovedPolyurethangeViasys Healthcard SystemsWheeling, IL, CORFLO, ULTRA 7Enteral Feeding TubeViasys MedSystemsWheeling, IL, Corkscrew Suture Anchor, PEEK Arthrex, www.arthrex.com, Corkscrew Suture Anchor, Titanium, Stainless Steel Arthrex, www.arthrex.com, CorMARK, Biopsy MarkerHologic, www.hologic.com, CorMarkTissue Marker14 gaugeEthicon EndosurgeryCincinnati, OH, CORNERSTONE PSR ImplantMedtronic, Inc., www.medtronic.com- Please refer to the labeling documents available at www.medtronic.com/mri, Coroflex ISAR NEO Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Coroflex ISAR Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Corograft Arterial Graft L-HydroLabcor Laboratorios Ltda., www.labcor.com, CORolla TAA DeviceCorAssist Cardiovascular Ltd., www.corassist.com, Coronary Vein MarkerMed-Edge, Inc., www.med-edge.info, Cortical bone screw4.5 x 36 mm (titanium alloy)orthopedic implantDePuy ACE Medical Co.El Segundo, CA, Cortical bone screwlarge (titanium alloy)orthopedic implantZimmerWarsaw, I, Cortical bone screwsmall (titanium alloy)orthopedic implantZimmerWarsaw, I, corVCD (implant for vessel coupling)corLife GBR, www.corlife.eu, Corvita EndoluminalGraft for AbdominalAortic Aneurysm27 x 120coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Cosgrove-Edwards Annuloplasty RingModel 4600, heart valveBaxter Healthcare CorporationISanta Ana, CA. Access instructions for use and other technical manuals in the Medtronic Manual Library.
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