Not doing so could result in injury or death. Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment PRODUCT DETAILS EXCEPTIONAL DESIGN For applicable products, consult instructions for use on manuals.medtronic.com. Selezionare la propria regione. Patients Update my browser now. 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. Up to 80% deployment. Raise your expectations for what is possiblewith the Evolut FX system. The Evolut PRO valve features an external tissue wrap added to the proven platform design. 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. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. MRI Verify | Medtronic PDF Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk You just clicked a link to go to another website. performance of the Evolut platform over time. Cardiovascular If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Broadest annulus range based on CT-derived diameters. Manuals and technical guides 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. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. With an updated browser, you will have a better Medtronic website experience. Evolut PRO System Sealing + Performance 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. With an updated browser, you will have a better Medtronic website experience. Object Status: It is possible that some of the products on the other site are not approved in your region or country. 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. Update my browser now. Evolut FX TAVR/TAVI Deployment Video During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Lowest delivery profile Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic This study is a prospective, single arm, multi-center . Products All other brands are trademarks of a Medtronic company. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Products You may also call 800-961-9055 for a copy of a manual. J Am Coll Cardiol. 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. 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. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. 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. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Third attempt must be a complete recapture and retrieval from patient. Evolut PRO+ - Transcatheter Aortic Heart Valves | Medtronic Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Access instructions for use and other technical manuals in the Medtronic Manual Library. What is Evolut pro valve made of? - Studybuff 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). Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Home 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. The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. Flameng, W, et al. 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. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI Broadest annulus range based on CT derived diameters. Evolut PRO System Sealing + Performance The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Transcatheter Aortic Heart Valves Pibarot P, Dumesnil JG. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, R System, the commercial name of the Evolut, PRO+ System, and the commercial name of the Evolut, 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, myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade, coronary occlusion, obstruction, or vessel spasm (including acute coronary closure), cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention), emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty), prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement prosthetic valve migration/embolization, delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time, delivery catheter system component migration/embolization, stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits, individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure, major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding), vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis), conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker. Update my browser now. 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 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. Heart. For best results, use Adobe Acrobat Reader with the browser. 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 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.