Antibiotics maybe recommendedfor patients who are at risk of infections. Transcatheter Aortic Heart Valves The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Medtronic MRI Verify allows you to look up the MR conditionality of a patient's Medtronic cardiac implantable electronic device based on the information available. Manuals can be viewed using a current version of any major internet browser. Update my browser now. 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. Medtronic Evolut TAVR System Shows Strong Performance at Two Years in 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 ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Manuals can be viewed using a current version of any major internet browser. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Third attempt must be a complete recapture and retrieval from patient. See how the external tissue wrap on the Evolut PRO TAVI performs. 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 <17 mm or >30 mm; 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. October 14, 2020 Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. Object Info: - MRI Safety Broadest annulus range based on CT derived diameters. January 2016;102(2):107-113. Find more detailed TAVRinformation, educationalresources, and tools. 2023 Medtronic . English. 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. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Evolut PRO System Sealing + Performance PDF Summary of Safety and Effectiveness Data I. General Information Your use of the other site is subject to the terms of use and privacy statement on that site. * Third party brands are trademarks of their respective owners. Indications, Safety, & Warnings. Title Transcatheter Aortic Valve Replacement (TAVR) with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement (SAVR) Product Name Medtronic TAVR System: xEvolut PRO Transcatheter Aortic Valve (TAV) 23, 26, and 29 mm xEvolut R 23, 26, 29, and 34 Prevent kinking of the catheter when removing it from the packaging. - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. Patients - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Third attempt must be a complete recapture and retrieval from patient. Less information (see less). Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Object Status: EVPROPLUS-29US: Medtronic Evolut Pro+ Transcatheter Aortic Valve 29mm 4564 0 obj <>/Filter/FlateDecode/ID[<2C0E24D68A9BFB4295F1AF0A6EE224DC>]/Index[4544 45]/Info 4543 0 R/Length 94/Prev 676184/Root 4545 0 R/Size 4589/Type/XRef/W[1 2 1]>>stream Find additional feature information, educational resources, and tools. These legacy and new design features provide the following sealing mechanisms: The Evolut TAVI platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. Pibarot P, Dumesnil JG. Access instructions for use and other technical manuals in the Medtronic Manual Library. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email.

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