medtronic evolut pro valve mri safety

hbbd``b`kS`o%@y)x Complications at the area where the doctor cutthe skin or related to cutting the skin, includingbut not limited to: Hematoma blood collecting under the skin, Pseudoaneurysm blood collecting on theoutside of a vessel wall causing a balloon-likewidening, Irreversible nerve damage permanentdamage to nerves, Compartment syndrome squeezing ofnerves and muscles in a closed space thatcould cause muscle or nerve damage, Stenosis narrowing of a blood vessel(artery), Mitral valve regurgitation blood leakingbackward through the valve between the leftlower chamber of the heart to the left upperchamber of the heart, Hypotension or hypertension low or highblood pressure, Bowel ischemia decreased blood supply tothe intestines. See how the external tissue wrap on the Evolut PRO TAVI performs. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: 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. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. Important Safety Information. 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. 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. Heart Valves and Annuloplasty Rings More. Access instructions for use and other technical manuals in the Medtronic Manual Library. 4588 0 obj <>stream Heart. Patients Prevent kinking of the catheter when removing it from the packaging. Size: 29mm; Aortic Annulus Diameter: 23-26mm; For Use With. 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. You may also call 800-961-9055 for a copy of a manual. 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 bioprosthesis size must be appropriate to fit the patients anatomy. Smooth, controlled, precise, and predictable. Home If you continue, you may go to a site run by someone else. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. 0 For best results, use Adobe Acrobat Reader with the browser. Healthcare Professionals 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. - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Home Medtronic, www.medtronic.com 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. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Home It is possible that some of the products on the other site are not approved in your region or country. General Clinical long-term durability has not been established for the bioprosthesis. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. Circulation. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . With an updated browser, you will have a better Medtronic website experience. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI November 1, 1999;34(5):1609-1617. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Cardiovascular $/R$J101 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 Click OK to confirm you are a Healthcare Professional. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). For best results, use Adobe Acrobat Reader with the browser. Cardiovascular `)\;>! 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. Healthcare Professionals More information (see more) Access instructions for use and other technical manuals in the Medtronic Manual Library. Find additional feature information, educational resources, and tools. Products Search by the product name (e.g., Evolut) or model number. Evolut PRO+. Products 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. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Update my browser now. Broadest annulus range based on CT derived diameters. Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. Medtronic, www.medtronic.com. January 2016;102(2):107-113. Please talk to your doctor to decide whether this therapy is right for you. Your use of the other site is subject to the terms of use and privacy statement on that site. Search by the product name (e.g., Evolut) or model number. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. 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: definition, clinical impact, and prevention. August 2006;92(8);1022-1029. Healthcare Professionals Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name Keep appointments with your doctor. 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. Reach out to LifeLine CardioVascular Tech Supportwith questions. 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. Damage may result from forceful handling of the catheter. Products Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. Broadest annulus range based onCT-derived diameters. Heart. PDF View Shellock R & D Services, Inc. email: . 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. You just clicked a link to go to another website. Third attempt must be a complete recapture and retrieval from patient. 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). See the Evolut R System. The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Products Avoid prolonged or repeated exposure to the vapors. Less information (see less). Prior to the procedure, measure the patients creatinine level. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. Heart. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. All other brands are trademarks of a Medtronic company. Transcatheter Aortic Heart Valves Follow all care instructions to ensure the best possible results. 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. Curr Treat Options Cardiovasc Med. The Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap on all valve sizes. Object Status Conditional 8. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). Third attempt must be a complete recapture and retrieval from patient. It is possible that some of the products on the other site are not approved in your region or country. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Skip to main content English J Am Coll Cardiol. With an updated browser, you will have a better Medtronic website experience. How long it lasts varies from patient to patient. Anatomical characteristics should be considered when using the valve in this population. Healthcare Professionals Your dentist and all doctors need to know about your Medtronic TAVR valve. Excessive contrast media may cause renal failure. Manuals can be viewed using a current version of any major internet browser. Cardiovascular 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. Shellock R & D Services, Inc. email: [email protected]. In addition, patient age should be considered as long-term durability of the valve has not been established. Your doctor can let you know which risks will most likely apply to you. 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. 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. Find more detailed TAVRinformation, educationalresources, and tools. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. * Third party brands are trademarks of their respective owners. Flameng, W, et al. Pibarot P, Dumesnil JG. Search by the product name (e.g., Evolut) or model number. DUBLIN, Aug. 24, 2021 / PRNewswire (opens new window) / -- Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Cardiovascular TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 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. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. August 2006;92(8);1022-1029. Safety Topic / Subject Heart Valves and Annuloplasty Rings. 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. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . Select country / region and language . Or, you may contact technical support online. 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 (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W Healthcare Professionals 2020 Medtronic. 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. Indications, Safety, & Warnings. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. See how the external tissue wrap on the Evolut PRO TAV performs. 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. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. 3: Conditional 5 More. For applicable products, consult instructions for use on manuals.medtronic.com. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Broadest annulus range* Less information (see less). Evolut FX. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Update my browser now. 2020 Medtronic. More information (see more) 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 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). 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. Manuals and technical guides including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Manuals can be viewed using a current version of any major internet browser. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. 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. 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. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Find more detailed TAVRinformation, educationalresources, and tools. Search by the product name (e.g., Evolut) or model number. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 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. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. Evolut PRO System Sealing + Performance Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Search by the product name (e.g., Evolut) or model number. 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. It is possible that some of the products on the other site are not approved in your region or country. Less information (see less). Update my browser now. t X Your use of the other site is subject to the terms of use and privacy statement on that site. Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US. The external wrap increases surface contact with native anatomy, providing advanced sealing. At some point, the Medtronic TAVR valve may need tobe replaced. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Home 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. With an updated browser, you will have a better Medtronic website experience. PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS More information (see more) Reach out to LifeLine CardioVascular Tech Support with questions. 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. Cardiovascular Update my browser now. 4544 0 obj <> endobj 2010; 121:2123-2129. We are here for you. Home $G` The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy You may also call 800-961-9055for a copy of a manual. T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. 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. Pibarot P, Dumesnil JG. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Circulation. %PDF-1.5 % Seleccione su regin. Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. November 2016;18(11):67. For applicable products, consult instructions for use on manuals.medtronic.com. Explore our valve design and theperformance of the Evolut platform over time. Lowest delivery profile Evolut FX Products Healthcare Professionals Products 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. Transcatheter Aortic Valve Replacement (TAVR) Transcatheter Aortic Heart Valves Transcatheter Aortic Heart Valves Access instructions for use and other technical manuals in the Medtronic Manual Library. Update my browser now. What is a Medtronic valve? 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. This could make you feel sick or cause death. November 2016;18(11):67. Cardiovascular The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. 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. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Radiopaque gold markers provide a reference for deployment depth and commissure location. Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. Recapture and reposition 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.

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