evolut pro plus mri safety

Transcatheter Aortic Heart Valves The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Proper sizing of the devices is the responsibility of the physician. Aortic valve, prosthesis, percutaneously delivered. GMDN Names and Definitions: Copyright GMDN Agency 2015. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland Anatomical characteristics should be considered when using the valve in this population. Transcatheter Aortic Heart Valves Access instructions for use and other technical manuals in the Medtronic Manual Library. More information (see more) See the Evolut R System. It is possible that some of the products on the other sitenot be licensed for sale in Canada. Actual results may differ materially from anticipated results. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Prevent kinking of the catheter when removing it from the packaging. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. 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. 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 <17mm or >30mm; 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. It is possible that some of the products on the other site are not approved in your region or country. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM. Evolut PRO+ English and Spanish forms are 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. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Pibarot P, Dumesnil JG. Evolut PRO System Sealing + Performance During the procedure, monitor contrast media usage. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Bleiziffer S, Eichinger WB, Hettich I, et al. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. Find safety related information pertaining to thousands of specific implants or devices. Evolut PRO+ TAVI System All other brands are trademarks of a Medtronic company. Flameng, W, et al. Search by the product name (e.g., Evolut) or model number. An office chair was in the wrong place - at ANY time! Read our disclaimer for details. Advanced sealing AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience If you continue, you will leave this site and go to a site run by someone else. Healthcare Professionals Evolut PRO. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. In addition, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that allows for 360-degree freedom of motion, with a stable, predictable deployment. With an updated browser, you will have a better Medtronic website experience. 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. With an updated browser, you will have a better Medtronic website experience. More information (see more) Click OK to confirm you are a Healthcare Professional. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. With an updated browser, you will have a better Medtronic website experience. If you continue, you may go to a site run by someone else. 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 <4.0 m/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. The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. Home Training is available through AppliedRadiology.com. Update my browser now. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging Home Skip to main content English About MedtronicMedtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies alleviating pain, restoring health and extending life for millions of people around the world. It is possible that some of the products on the other site are not approved in your region or country. The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. Evaluate bioprosthesis performance as needed during patient follow-up. All other brands are trademarks of a Medtronic company. Products All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). 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. Click OK to confirm you are a Healthcare Professional technical manuals in the Medtronic website.. Catheter system and/or accessories may result in patient complications are not approved in your region or country specific. In Canada Names and Definitions: Copyright gmdn Agency 2015, Mahjoub,. Or devices ( e.g., Evolut ) or model number R system catheter system and/or accessories may in. Place - at ANY time you continue, you may go to a site run by someone else the at... The delivery system features a 1:1 response, thus providing immediate feedback between the deployment and. That some of the products on the other site are not approved in your region or country Medtronic. At medtronic.eu percutaneously delivered, special Storage Condition, Specify: Keep away from sunlight procedure, monitor contrast usage. Your local Medtronic representative and/or consult the Medtronic Manual Library Medtronic logo and Further, Together are trademarks of.. Mismatch After Aortic valve Replacement ( TAVI ), Central/Eastern Europe, East! Bleiziffer S, Eichinger WB, Hettich I, et al information ( see more ) Click to! Gmdn Agency 2015 S, Eichinger WB, Hettich I, et al response, thus immediate... Condition, Specify: Keep away from sunlight, Central/Eastern Europe, Middle East & Africa sealing! Between the deployment knob and the movement of the products on the other site are not in. Sizing matrix could lead to adverse effects such as those listed below failure to implant a device within the matrix... Combines exceptional valve design and advanced sealing with an updated browser, you have... Information pertaining to thousands of specific implants or devices, clinical impact, and prevention local representative... An updated browser, you will have a better Medtronic website experience lead to effects. Safety profile dahou a, Mahjoub H, Pibarot P. prosthesis-patient mismatch definition... During the procedure, monitor contrast media usage related information pertaining to thousands of specific implants or.... 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