Find additional feature information, educational resources, and tools. 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. Healthcare Professionals PRODUCT DETAILS EXCEPTIONAL DESIGN Conduct the procedure under fluoroscopy. 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). Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. If you continue, you may go to a site run by someone else. 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 Your use of the other site is subject to the terms of use and privacy statement on that site. With an updated browser, you will have a better Medtronic website experience. Excessive contrast media may cause renal failure. 2020 Medtronic. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. Update my browser now. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Third attempt must be a complete recapture and retrieval from patient. The Evolut PRO valve features an external tissue wrap added to the proven platform design. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Less information (see less). Access instructions for use and other technical manuals in the Medtronic Manual Library. Home At some point, the Medtronic TAVR valve may need tobe replaced. Circulation. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. Patients who do not are more likely to have a stroke. Products Search by the product name (e.g., Evolut) or model number. Reach out to LifeLine CardioVascular Tech Support with questions. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. $G` 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). Heart. Seleccione su regin. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. You may also call800-961-9055 for a copy of a manual. Cardiovascular All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Keep appointments with your doctor. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. 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. 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 Transcatheter Aortic Heart Valves. Update my browser now. 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. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). If you continue, you may go to a site run by someone else. . The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Heart. Healthcare Professionals Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. 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. Avoid prolonged or repeated exposure to the vapors. Reach out to LifeLine CardioVascular Tech Support with questions. Implanting a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis in a degenerated surgical bioprosthetic valve (transcatheter aortic valve in surgical aortic valve [TAV-in-SAV]) should be avoided in the following conditions: The degenerated surgical bioprosthetic valve presents with: a significant concomitant paravalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g., wire form frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer-labeled inner diameter < 17 mm. 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. Meet the Evolut R System. Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. November 2016;18(11):67. Cardiovascular With an updated browser, you will have a better Medtronic website experience. 3: Conditional 5 More. 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. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US Manuals and technical guides More information (see more) Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: All other brands are trademarks of a Medtronic company. Object Category Heart Valves and Annuloplasty Rings. In addition, patient age should be considered as long-term durability of the valve has not been established. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Cardiovascular SPECIFICATIONS Evolut PRO+ TAV R BIOPROSTHESIS Evolut PRO+ 23 mm Valve Evolut PRO+ 26 mm Valve Model Number: EVPROPLUS-23US Size: 23 mm Aortic annulus diameter: 17*/18-20 mm Model Number: EVPROPLUS-26US Size: 26 mm Aortic annulus diameter: 20-23 mm LOADING SYSTEM Evolut PRO+ Loading System Model Number: L-EVPROP2329US Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Heart Valves and Annuloplasty Rings More. Healthcare Professionals The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Healthcare Professionals Update my browser now. Go . MRI Resources, For clinicians whose patients have a Medtronic system. Update my browser now. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Access instructions for use and other technical manuals in the Medtronic Manual Library. More information (see more) Allows access down to5.0 mm vessels with2329 mm valves. The EnVeo PRO delivery system assists in accurate positioning of the valve. The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. Broadest annulus range* * Third party brands are trademarks of their respective owners. Curr Treat Options Cardiovasc Med. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. See how the external tissue wrap on the Evolut PRO TAV performs. Pibarot P, Dumesnil JG. Object Status Conditional 8. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. * Third party brands are trademarks of their respective owners. Home T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. You may also call 800-961-9055for a copy of a manual. 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. MRI-Related Heating In non-clinical testing, the implant/device produced the following temperature rises during MRI performed for 15-minutes (i.e. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. PRODUCT DETAILS EXCEPTIONAL DESIGN Important Safety Information. 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. Evolut PRO System Sealing + Performance Select country / region and language . 2020 Medtronic. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Third attempt must be a complete recapture and retrieval from patient. Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. Indications, Safety, and Warnings Product Details hbbd``b`kS`o%@y)x Evolut FX. 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. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. The external wrap increases surface contact with native anatomy, providing advanced sealing. 2010; 121:2123-2129. Pibarot P, Dumesnil JG. Raise your expectations for what is possiblewith the Evolut FX system. Healthcare Professionals 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. With an updated browser, you will have a better Medtronic website experience. 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. All other brands are trademarks of a Medtronic company. 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. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Bench testing may not be indicative of clinical performance. Transcatheter Aortic Heart Valves Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. Healthcare Professionals The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. Dysfunctions of a Medtronic TAVR valve,including but not limited to: Valve frame does not open (expand) allthe way, Pannus the formation of scar tissuethat may cover or block the valve fromfunctioning normally, Wear, tear, or movement forward (prolapse)or backward (retraction) from the normalposition of the valve leaflets, A break in the stitches (sutures) of the valveframe or leaflets, Leakage through or around the valve orvalve frame, Incorrect position of the valve, either toohigh or too low, Regurgitation backward flow of bloodthrough the valve, Stenosis narrowing of the opening ofthe valve, Valve migration upward or downwardmovement of the device from where itwasoriginally placed, Embolism an abnormal particle (air, bloodclots) floating in the blood stream or attachedto an object, including the valve or deliverysystem component, Infection of the heart, blood, or other areas, Thrombosis (including valve thrombosis) blood clot, including a blood clot on the valve, Individual or multi-organ insufficiency or failure. Cardiovascular TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. With an abnormal growth in the heart or arteries, Whose failing valve is too small or too big, Whose arteries are too small for the device, Whose arteries that deliver blood to the heart maybe blockedby the device, Whose arteries that deliver blood to the heart need tobe treated, Whose arteries that deliver blood to the brain need tobe treated, Who have a reaction to some imaging solutions, cannot take medications that reduce the risk of blood clots, or who have a reaction to somemetals, Who have severe problems with bleeding or bloodclotting, Who have specific types of surgical valves implanted in the pulmonaryvalve, Who have specific types of surgical valves implanted in the mitralvalve, Who have thick heart muscles, making it difficult for the heart to pumpblood, Who have thick heart muscles that block the heart from pumpingblood, Who need to have a surgical procedure on theiraorta. 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. 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. 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 Language Remember My Preferences. Skip to main content English %%EOF endstream endobj 4545 0 obj <. Find more detailed TAVRinformation, educationalresources, and tools. TAVR currentlyis approvedfor patients withheart diseasedue to symptomatic severe aortic stenosis of the native valve, and patients with a failingsurgical aortic valve who are at high risk or extreme riskdue to symptomatic, severe aortic stenosis for complications during surgery. November 2016;18(11):67. 2010; 121:2123-2129. Find more detailed TAVRinformation, educationalresources, and tools. Home Less information (see less). We are here for you. The EnVeo PRO delivery system assists in accurate positioning of the valve. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI 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. Click OK to confirm you are a Healthcare Professional. Curr Treat Options Cardiovasc Med. Refer to the Instructions for Use for available sizes. X'AD`4.$ 2 EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Bleiziffer S, Eichinger WB, Hettich I, et al. Products Up to 80% deployment. Selezionare la propria regione. Products Your dentist and all doctors need to know about your Medtronic TAVR valve. 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 Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. What is a Medtronic valve? 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. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Find more detailed TAVRinformation, educationalresources, and tools. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Evolut PRO System Sealing + Performance You just clicked a link to go to another website. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Broadest annulus range* Lowest delivery profile Patients Search by the product name (e.g., Evolut) or model number. Heart. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. More information (see more) 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. Home Manuals can be viewed using a current version of any major internet browser. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. 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. It is possible that some of the products on the other site are not approved in your region or country. Veuillez slectionner votre rgion. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX Up to 80% deployment. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. English. 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. 4544 0 obj <> endobj Indications, Safety, & Warnings. Or, you may contact technical support online. Smooth, controlled, precise, and predictable. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Epub 2017 Oct 27. Damage may result from forceful handling of the catheter. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. The bioprosthesis size must be appropriate to fit the patients anatomy. Prevent kinking of the catheter when removing it from the packaging. 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. Evaluate bioprosthesis performance as needed during patient follow-up. See how the external tissue wrap on the Evolut PRO TAVI performs. 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. Flameng, W, et al. August 2006;92(8);1022-1029. 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. 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. Healthcare Professionals Brand Name: Evolut PRO+ Version or Model: EVPROPLUS-29US Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC COREVALVE LLC Primary DI Number: 00763000211127 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527231 * Terms of Use The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. 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. 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.
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