The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). `)\;>! Smooth, controlled, precise, and predictable. Radiopaque gold markers provide a reference for deployment depth and commissure location. 4588 0 obj <>stream 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. Curr Treat Options Cardiovasc Med. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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. Broadest annulus range* You may also call800-961-9055 for a copy of a manual. 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. Transcatheter Aortic Heart Valves For applicable products, consult instructions for use on manuals.medtronic.com. 3: Conditional 5 More. More information (see more) Follow all care instructions to ensure the best possible results. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Skip to main content English Evaluate bioprosthesis performance as needed during patient follow-up. You just clicked a link to go to another website. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. X'AD`4.$ 2 Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. Up to 80% deployment. Avoid prolonged or repeated exposure to the vapors. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. These legacy and new design features provide the following sealing mechanisms: The Evolut TAVR platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. Healthcare Professionals From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Home Heart. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. MRI Verify | Medtronic Proper sizing of the devices is the responsibility of the physician. All other brands are trademarks of a Medtronic company. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. Indications, Safety, and Warnings Product Details Click OK to confirm you are a Healthcare Professional. Broadest annulus range based onCT-derived diameters. Evolut FX TAVR/TAVI Deployment Video Reach out to LifeLine CardioVascular Tech Support with questions. 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 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. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. For best results, use Adobe Acrobat Reader with the browser. Keep appointments with your doctor. With an updated browser, you will have a better Medtronic website experience. Healthcare Professionals For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic endstream endobj 4545 0 obj <. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. This could make you feel sick or cause death. $/R$J101 Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). Recapture and reposition Evolut PRO System Sealing + Performance Products Your use of the other site is subject to the terms of use and privacy statement on that site. Evolut PRO China Clinical Study - Full Text View - ClinicalTrials.gov The EnVeo PRO delivery system assists in accurate positioning of the valve. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. Heart. Selezionare la propria regione. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. For applicable products, consult instructions for use on manuals.medtronic.com. 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. The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. Circulation. Conduct the procedure under fluoroscopy. Transcatheter Aortic Heart Valves 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. Object Info: - MRI Safety The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic CoreValve Evolut Pro and Pro . Language Remember My Preferences. Medtronic Launches Head-to-Head TAVR Study Comparing the Corevalve Access instructions for use and other technical manuals in the Medtronic Manual Library. 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. 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). Heart Valves and Annuloplasty Rings More. Transcatheter Aortic Heart Valves %%EOF 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 <4.0m/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. 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. Heart. Update my browser now. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered .