Search by the product name (e.g., Evolut) or model number. Less information (see less). We are here for you. The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe. 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. Transcatheter Aortic Heart Valves Home 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. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. 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. All other brands are trademarks of a Medtronic company. Please talk to your doctor to decide whether this therapy is right for you. 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. Flameng, W, et al. 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. Reach out to LifeLine CardioVascular Tech Support with questions. hb```lu eah(x B Cardiovascular 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. You may also call800-961-9055 for a copy of a manual. English. Medtronic, www.medtronic.com. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. 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% See how the external tissue wrap on the Evolut PRO TAVI performs. 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. Update my browser now. Transcatheter Aortic Heart Valves With an updated browser, you will have a better Medtronic website experience. Broadest annulus range* Your doctor can let you know which risks will most likely apply to you. More information (see more) 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 Circulation. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. `)\;>! For best results, use Adobe Acrobat Reader with the browser. %%EOF Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . Or, you may contact technical support online. Up to 80% deployment. 4588 0 obj <>stream Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US Cardiovascular 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. Medtronic MRI Resource Library Technical Information for Healthcare Professionals. 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. Recapture and reposition More information (see more) Home Medtronic, www.medtronic.com AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR), 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. Refer to the Instructions for Use for available sizes. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and has the ability to treat the broadest annulus range* of any commercially available TAVR system. Heart. 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 subclavian access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either 5.5mm when using models ENVEOR-L-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 6mm when using model ENVEOR-N-US or 6.5mm when using models D-EVPROP34US/D-EVOLUTFX-34. If you continue, you may go to a site run by someone else. Evolut FX Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Healthcare Professionals You may also call 800-961-9055 for a copy of a manual. Excessive contrast media may cause renal failure. See how the external tissue wrap on the Evolut PRO TAV performs. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. With an updated browser, you will have a better Medtronic website experience. Strength 1.5, 3. 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. * Third party brands are trademarks of their respective owners. Home Search by the product name (e.g., Evolut) or model number. Broadest annulus range based on CT derived diameters. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. You just clicked a link to go to another website. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. The external wrap increases surface contact with native anatomy, providing advanced sealing. With an updated browser, you will have a better Medtronic website experience. Prevent kinking of the catheter when removing it from the packaging. Language Remember My Preferences. January 2016;102(2):107-113. Home The bioprosthesis size must be appropriate to fit the patients anatomy. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. 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. Less information (see less). Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic 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. Cardiovascular November 1, 1999;34(5):1609-1617. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. The Evolut PRO valve features an external tissue wrap added to the proven platform design. November 2016;18(11):67. For applicable products, consult instructions for use on manuals.medtronic.com. Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. Access instructions for use and other technical manuals in the Medtronic Manual Library. Broadest annulus range* PRODUCT DETAILS EXCEPTIONAL DESIGN 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 require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. This study is a prospective, single arm, multi-center . Transcatheter Aortic Heart Valves 2010; 121:2123-2129. With an updated browser, you will have a better Medtronic website experience. 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. 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. Follow all care instructions to ensure the best possible results. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Update my browser now. 2020 Medtronic. 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. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Less information (see less). 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 . Conduct the procedure under fluoroscopy. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang Authors Dhruv Mahtta 1 , Islam Y Elgendy 2 , Anthony A Bavry 3 4 Affiliations 1 Department of Medicine, University of Florida, Gainesville, FL, USA. 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. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30 for right subclavian/axillary access or >70 for femoral and left subclavian/axillary access. Access instructions for use and other technical manuals in the Medtronic Manual Library. See how the external tissue wrap on the Evolut PRO TAVI performs. Reach out to LifeLine CardioVascular Tech Support with questions. Transcatheter Aortic Heart Valves. Bitte whlen Sie Ihre Region. 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. Click OK to confirm you are a Healthcare Professional. See how the external tissue wrap on the Evolut PRO TAV performs. If you continue, you may go to a site run by someone else. 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. 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. Transcatheter Aortic Heart Valves Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. See the Evolut R System. Heart. It is possible that some of the products on the other site are not approved in your region or country. Broadest annulus range based on CT-derived diameters. Evaluate bioprosthesis performance as needed during patient follow-up. In addition, patient age should be considered as long-term durability of the valve has not been established. Explore our valve design and theperformance of the Evolut platform over time. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. X'AD`4.$ 2 With an updated browser, you will have a better Medtronic website experience. Bench testing may not be indicative of clinical performance. 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. Evolut FX system enhancements make TAVR procedures easier to visualize and more predictable. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. 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. Manuals can be viewed using a current version of any major internet browser. Treatments & Therapies What is a Medtronic valve? Damage may result from forceful handling of the catheter. Broadest annulus range based onCT-derived diameters. 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. Curr Treat Options Cardiovasc Med. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Healthcare Professionals Important Safety Information - Transcatheter Aortic Valve Replacement (TAVR) | Medtronic Your browser is out of date With an updated browser, you will have a better Medtronic website experience. Please select your region. With an updated browser, you will have a better Medtronic website experience. 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). Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Bleiziffer S, Eichinger WB, Hettich I, et al. 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. Transcatheter Aortic Heart Valves Healthcare Professionals The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. Broadest annulus range based on CT derived diameters. Pibarot P, Dumesnil JG. 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 Update my browser now. Go . - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. J Am Coll Cardiol. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. For best results, use Adobe Acrobat Reader with the browser. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. 2023 Medtronic . including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Manuals and technical guides Cardiovascular endstream endobj 4545 0 obj <. 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. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Meet the Evolut R System. 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. 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. Manuals can be viewed using a current version of any major internet browser. Broadest annulus range based on CT derived diameters. Healthcare Professionals Not doing so could result in injury or death. 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. Indications, Safety, and Warnings Product Details 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. 3: Conditional 5 More. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. The Evolut PRO valve features an external tissue wrap added to the proven platform design. At some point, the Medtronic TAVR valve may need tobe replaced. Products TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. * Third party brands are trademarks of their respective owners. Update my browser now. 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. Object Status Conditional 8. Heart Valves and Annuloplasty Rings More. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Patients must present with transarterial access vessel diameters of 5mm when using models ENVEOR-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 5.5mm when using model ENVEOR-N-US or 6mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site 60mm from the basal plane for both systems. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Healthcare Professionals United States of America * Country / Region. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Transcatheter aortic valve replacement (TAVR), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Cardiogenic shock failure of the heart topump enough blood to the body organs, Cardiac tamponade the constriction orinability of the heart to pump due to buildup ofblood or fluidaround the lining of the heart, Perforation of the myocardium or vessel ahole in the heart muscle or a blood vessel, Partial or complete block of coronary artery(that supplies blood to the heart), Ascending aorta trauma injury to the largeblood vessel leading blood away from the heart, Additional cardiac surgery, vascular surgery, orintervention, including removal of the TAV. With an updated browser, you will have a better Medtronic website experience. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Reach out to LifeLine CardioVascular Tech Supportwith questions. 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). Indications, Safety, & Warnings. Pibarot P, Dumesnil JG. Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. Click OK to confirm you are a Healthcare Professional. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Third attempt must be a complete recapture and retrieval from patient. With an updated browser, you will have a better Medtronic website experience. Products Third attempt must be a complete recapture and retrieval from patient. Evolut PRO+.
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